Trial Outcomes & Findings for The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3) (NCT NCT03583099)
NCT ID: NCT03583099
Last Updated: 2024-09-19
Results Overview
Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
COMPLETED
NA
2004 participants
Baseline to 12 months
2024-09-19
Participant Flow
Unit of analysis: Practices
Participant milestones
| Measure |
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
Enhanced Usual Care: COPD Education
Practice clinicians received COPD education only.
|
|---|---|---|
|
Overall Study
STARTED
|
1118 51
|
886 48
|
|
Overall Study
Primary Analysis Population
|
226 49
|
161 44
|
|
Overall Study
COMPLETED
|
802 51
|
613 46
|
|
Overall Study
NOT COMPLETED
|
316 0
|
273 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
Baseline characteristics by cohort
| Measure |
Intervention Arm: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=51 practices
Intervention Arm: Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
Enhanced Usual Care Arm: COPD Education
n=48 practices
Enhanced Usual Care Arm: Practice clinicians received basic COPD education only.
|
Total
n=99 practices
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 9 • n=1118 Participants
|
63 Years
STANDARD_DEVIATION 9 • n=886 Participants
|
62 Years
STANDARD_DEVIATION 9 • n=2004 Participants
|
|
Sex: Female, Male
Female
|
677 Participants
n=1118 Participants
|
530 Participants
n=886 Participants
|
1207 Participants
n=2004 Participants
|
|
Sex: Female, Male
Male
|
441 Participants
n=1118 Participants
|
356 Participants
n=886 Participants
|
797 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Non-Latino
|
984 Participants
n=1118 Participants
|
711 Participants
n=886 Participants
|
1695 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
89 Participants
n=1118 Participants
|
149 Participants
n=886 Participants
|
238 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Don't Know/Prefer not to answer
|
45 Participants
n=1118 Participants
|
22 Participants
n=886 Participants
|
67 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Missing Data
|
0 Participants
n=1118 Participants
|
2 Participants
n=886 Participants
|
2 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
362 Participants
n=1118 Participants
|
236 Participants
n=886 Participants
|
598 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
White
|
642 Participants
n=1118 Participants
|
514 Participants
n=886 Participants
|
1156 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Other than White or Black/African American
|
62 Participants
n=1118 Participants
|
44 Participants
n=886 Participants
|
106 Participants
n=2004 Participants
|
|
Race/Ethnicity, Customized
Don't know/Prefer not to answer
|
52 Participants
n=1118 Participants
|
90 Participants
n=886 Participants
|
142 Participants
n=2004 Participants
|
|
Body Max Index (BMI)
|
33 kg/m2
STANDARD_DEVIATION 8 • n=1118 Participants
|
33 kg/m2
STANDARD_DEVIATION 8 • n=886 Participants
|
33 kg/m2
STANDARD_DEVIATION 8 • n=2004 Participants
|
|
Enrollment Date
Before March 20, 2019
|
284 Participants
n=1118 Participants
|
80 Participants
n=886 Participants
|
364 Participants
n=2004 Participants
|
|
Enrollment Date
March 20, 2019 - November 19, 2019
|
277 Participants
n=1118 Participants
|
301 Participants
n=886 Participants
|
578 Participants
n=2004 Participants
|
|
Enrollment Date
Sep 20, 2019 - Mar 19, 2020
|
264 Participants
n=1118 Participants
|
307 Participants
n=886 Participants
|
571 Participants
n=2004 Participants
|
|
Enrollment Date
Mar 20, 2020 or later
|
293 Participants
n=1118 Participants
|
198 Participants
n=886 Participants
|
491 Participants
n=2004 Participants
|
|
Education
Less than high school
|
128 Participants
n=1118 Participants
|
118 Participants
n=886 Participants
|
246 Participants
n=2004 Participants
|
|
Education
High school or GED
|
298 Participants
n=1118 Participants
|
231 Participants
n=886 Participants
|
529 Participants
n=2004 Participants
|
|
Education
Vocational school or some college
|
310 Participants
n=1118 Participants
|
197 Participants
n=886 Participants
|
507 Participants
n=2004 Participants
|
|
Education
College degree
|
250 Participants
n=1118 Participants
|
218 Participants
n=886 Participants
|
468 Participants
n=2004 Participants
|
|
Education
Professional or graduate degree
|
127 Participants
n=1118 Participants
|
118 Participants
n=886 Participants
|
245 Participants
n=2004 Participants
|
|
Education
Missing Data
|
5 Participants
n=1118 Participants
|
4 Participants
n=886 Participants
|
9 Participants
n=2004 Participants
|
|
Employment
Working part-time or full-time
|
198 Participants
n=1118 Participants
|
141 Participants
n=886 Participants
|
339 Participants
n=2004 Participants
|
|
Employment
Not working for reason other than disability
|
488 Participants
n=1118 Participants
|
368 Participants
n=886 Participants
|
856 Participants
n=2004 Participants
|
|
Employment
Not working due to disability
|
427 Participants
n=1118 Participants
|
376 Participants
n=886 Participants
|
803 Participants
n=2004 Participants
|
|
Employment
Missing
|
5 Participants
n=1118 Participants
|
1 Participants
n=886 Participants
|
6 Participants
n=2004 Participants
|
|
Health insurance
Private or both private and public insurance
|
562 Participants
n=1118 Participants
|
467 Participants
n=886 Participants
|
1029 Participants
n=2004 Participants
|
|
Health insurance
Public insurance or no insurance
|
532 Participants
n=1118 Participants
|
407 Participants
n=886 Participants
|
939 Participants
n=2004 Participants
|
|
Health insurance
Other/Don't know
|
24 Participants
n=1118 Participants
|
12 Participants
n=886 Participants
|
36 Participants
n=2004 Participants
|
|
Participants with a history of asthma
True
|
913 Participants
n=1118 Participants
|
723 Participants
n=886 Participants
|
1636 Participants
n=2004 Participants
|
|
Participants with a history of asthma
False
|
203 Participants
n=1118 Participants
|
162 Participants
n=886 Participants
|
365 Participants
n=2004 Participants
|
|
Participants with a history of asthma
Missing
|
2 Participants
n=1118 Participants
|
1 Participants
n=886 Participants
|
3 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
No asthma, and no respiratory medication
|
825 Participants
n=1118 Participants
|
661 Participants
n=886 Participants
|
1486 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
No asthma, but short-acting bronchodilator (SABD) or maintenance respiratory medication
|
87 Participants
n=1118 Participants
|
62 Participants
n=886 Participants
|
149 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
No asthma with no respiratory medication
|
67 Participants
n=1118 Participants
|
45 Participants
n=886 Participants
|
112 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
Asthma with SABD only
|
59 Participants
n=1118 Participants
|
54 Participants
n=886 Participants
|
113 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
Asthma with maintenance respiratory medication
|
77 Participants
n=1118 Participants
|
62 Participants
n=886 Participants
|
139 Participants
n=2004 Participants
|
|
Asthma and respiratory medication
Missing Data
|
3 Participants
n=1118 Participants
|
2 Participants
n=886 Participants
|
5 Participants
n=2004 Participants
|
|
Cigarette smoking
Never
|
518 Participants
n=1118 Participants
|
456 Participants
n=886 Participants
|
974 Participants
n=2004 Participants
|
|
Cigarette smoking
Former
|
373 Participants
n=1118 Participants
|
283 Participants
n=886 Participants
|
656 Participants
n=2004 Participants
|
|
Cigarette smoking
Current
|
223 Participants
n=1118 Participants
|
146 Participants
n=886 Participants
|
369 Participants
n=2004 Participants
|
|
Cigarette smoking
Missing
|
4 Participants
n=1118 Participants
|
1 Participants
n=886 Participants
|
5 Participants
n=2004 Participants
|
|
Maintenance respiratory medication
None
|
1014 Participants
n=1118 Participants
|
798 Participants
n=886 Participants
|
1812 Participants
n=2004 Participants
|
|
Maintenance respiratory medication
Inhaled Corticosteroids (ICS) alone
|
31 Participants
n=1118 Participants
|
22 Participants
n=886 Participants
|
53 Participants
n=2004 Participants
|
|
Maintenance respiratory medication
Long-acting brochodilator (LABA) and ICS
|
63 Participants
n=1118 Participants
|
55 Participants
n=886 Participants
|
118 Participants
n=2004 Participants
|
|
Maintenance respiratory medication
Other combination of LABA, Long-acting beta2-agonist (LAMA), and ICS
|
9 Participants
n=1118 Participants
|
10 Participants
n=886 Participants
|
19 Participants
n=2004 Participants
|
|
Maintenance respiratory medication
Missing Data
|
1 Participants
n=1118 Participants
|
1 Participants
n=886 Participants
|
2 Participants
n=2004 Participants
|
|
Short-acting bronchodilator Use
True
|
197 Participants
n=1118 Participants
|
154 Participants
n=886 Participants
|
351 Participants
n=2004 Participants
|
|
Short-acting bronchodilator Use
False
|
920 Participants
n=1118 Participants
|
731 Participants
n=886 Participants
|
1651 Participants
n=2004 Participants
|
|
Short-acting bronchodilator Use
Missing Data
|
1 Participants
n=1118 Participants
|
1 Participants
n=886 Participants
|
2 Participants
n=2004 Participants
|
|
Number of participants with a COPD Assessment Test (CAT) Score ≥ 10
CAT score < 10
|
517 Participants
n=1118 Participants
|
451 Participants
n=886 Participants
|
968 Participants
n=2004 Participants
|
|
Number of participants with a COPD Assessment Test (CAT) Score ≥ 10
CAT score ≥ 10
|
600 Participants
n=1118 Participants
|
435 Participants
n=886 Participants
|
1035 Participants
n=2004 Participants
|
|
Number of participants with a COPD Assessment Test (CAT) Score ≥ 10
Missing Data
|
1 Participants
n=1118 Participants
|
0 Participants
n=886 Participants
|
1 Participants
n=2004 Participants
|
|
Number of participants with Modified Medical Research Council dyspnea score ≥ 2
True
|
831 Participants
n=1118 Participants
|
682 Participants
n=886 Participants
|
1513 Participants
n=2004 Participants
|
|
Number of participants with Modified Medical Research Council dyspnea score ≥ 2
False
|
285 Participants
n=1118 Participants
|
202 Participants
n=886 Participants
|
487 Participants
n=2004 Participants
|
|
Number of participants with Modified Medical Research Council dyspnea score ≥ 2
Missing
|
2 Participants
n=1118 Participants
|
2 Participants
n=886 Participants
|
4 Participants
n=2004 Participants
|
|
Acute respiratory illness in the past 12 months before baseline
True
|
151 Participants
n=1118 Participants
|
121 Participants
n=886 Participants
|
272 Participants
n=2004 Participants
|
|
Acute respiratory illness in the past 12 months before baseline
False
|
966 Participants
n=1118 Participants
|
763 Participants
n=886 Participants
|
1729 Participants
n=2004 Participants
|
|
Acute respiratory illness in the past 12 months before baseline
Missing
|
1 Participants
n=1118 Participants
|
2 Participants
n=886 Participants
|
3 Participants
n=2004 Participants
|
|
Forced Vital Capacity (FVC) percent of predicted value
|
82 percent predicted
STANDARD_DEVIATION 16 • n=1087 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
84 percent predicted
STANDARD_DEVIATION 18 • n=870 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
83 percent predicted
STANDARD_DEVIATION 17 • n=1957 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
|
Forced Expiratory Volume in 1 second (FEV1), percent of predicted value
|
81 percent predicted
STANDARD_DEVIATION 16 • n=1087 Participants • Missing data from 16 participants in the Enhance Usual Care Arm: COPD education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
82 percent predicted
STANDARD_DEVIATION 19 • n=870 Participants • Missing data from 16 participants in the Enhance Usual Care Arm: COPD education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
81 percent predicted
STANDARD_DEVIATION 17 • n=1957 Participants • Missing data from 16 participants in the Enhance Usual Care Arm: COPD education. Missing data from 31 participants in the Intervention Arm: COPD education plus CAPTURE education and patient-level CAPTURE screening results.
|
|
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) mean
|
77 percent
STANDARD_DEVIATION 8 • n=1087 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education Missing data from 31 participants in the Intervention Arm: COPD Education plus CAPTURE education and patient-level CAPTURE screening results
|
76 percent
STANDARD_DEVIATION 8 • n=870 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education Missing data from 31 participants in the Intervention Arm: COPD Education plus CAPTURE education and patient-level CAPTURE screening results
|
76 percent
STANDARD_DEVIATION 8 • n=1957 Participants • Missing data from 16 participants in the Enhanced Usual Care Arm: COPD Education Missing data from 31 participants in the Intervention Arm: COPD Education plus CAPTURE education and patient-level CAPTURE screening results
|
|
Spirometry classification
Normal spirometry
|
478 Participants
n=1118 Participants
|
382 Participants
n=886 Participants
|
860 Participants
n=2004 Participants
|
|
Spirometry classification
Preserved ratio, impaired spirometry
|
372 Participants
n=1118 Participants
|
278 Participants
n=886 Participants
|
650 Participants
n=2004 Participants
|
|
Spirometry classification
Spirometry-defined COPD
|
180 Participants
n=1118 Participants
|
164 Participants
n=886 Participants
|
344 Participants
n=2004 Participants
|
|
Spirometry classification
Undetermined
|
88 Participants
n=1118 Participants
|
62 Participants
n=886 Participants
|
150 Participants
n=2004 Participants
|
|
CAPTURE question 5 response
None
|
810 Participants
n=1118 Participants
|
672 Participants
n=886 Participants
|
1482 Participants
n=2004 Participants
|
|
CAPTURE question 5 response
Once
|
154 Participants
n=1118 Participants
|
109 Participants
n=886 Participants
|
263 Participants
n=2004 Participants
|
|
CAPTURE question 5 response
Two or more
|
154 Participants
n=1118 Participants
|
105 Participants
n=886 Participants
|
259 Participants
n=2004 Participants
|
|
Practice Baseline Characteristic: Practice Type
Part of large health system, Accountable Care Organization (ACO), or similar
|
17 practices
n=51 practices
|
18 practices
n=48 practices
|
35 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice Type
Part of academic medical center/health system
|
15 practices
n=51 practices
|
13 practices
n=48 practices
|
28 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice Type
Federally Qualified Health Center
|
10 practices
n=51 practices
|
8 practices
n=48 practices
|
18 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice Type
Independent practice
|
6 practices
n=51 practices
|
3 practices
n=48 practices
|
9 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice Type
Other
|
2 practices
n=51 practices
|
5 practices
n=48 practices
|
7 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice Type
Missing
|
1 practices
n=51 practices
|
1 practices
n=48 practices
|
2 practices
n=99 practices
|
|
Practice Baseline Characteristic: Number of primary care clinicians
0 - 4
|
17 practices
n=51 practices
|
17 practices
n=48 practices
|
34 practices
n=99 practices
|
|
Practice Baseline Characteristic: Number of primary care clinicians
5 -0
|
21 practices
n=51 practices
|
15 practices
n=48 practices
|
36 practices
n=99 practices
|
|
Practice Baseline Characteristic: Number of primary care clinicians
10 or more
|
11 practices
n=51 practices
|
14 practices
n=48 practices
|
25 practices
n=99 practices
|
|
Practice Baseline Characteristic: Number of primary care clinicians
Missing
|
2 practices
n=51 practices
|
2 practices
n=48 practices
|
4 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice is a residency site
Yes
|
13 practices
n=51 practices
|
7 practices
n=48 practices
|
20 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice is a residency site
No
|
37 practices
n=51 practices
|
40 practices
n=48 practices
|
77 practices
n=99 practices
|
|
Practice Baseline Characteristic: Practice is a residency site
Missing
|
1 practices
n=51 practices
|
1 practices
n=48 practices
|
2 practices
n=99 practices
|
|
Practice Baseline Characteristic: Spirometry is performed in-house
Yes
|
28 practices
n=51 practices
|
30 practices
n=48 practices
|
58 practices
n=99 practices
|
|
Practice Baseline Characteristic: Spirometry is performed in-house
No
|
22 practices
n=51 practices
|
17 practices
n=48 practices
|
39 practices
n=99 practices
|
|
Practice Baseline Characteristic: Spirometry is performed in-house
Missing
|
1 practices
n=51 practices
|
1 practices
n=48 practices
|
2 practices
n=99 practices
|
|
Practice Baseline Characteristic: Rural location
Yes
|
10 practices
n=51 practices
|
8 practices
n=48 practices
|
18 practices
n=99 practices
|
|
Practice Baseline Characteristic: Rural location
No
|
41 practices
n=51 practices
|
40 practices
n=48 practices
|
81 practices
n=99 practices
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsProportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD
|
41.9 percent
Interval 34.0 to 49.7
|
45.9 percent
Interval 38.3 to 53.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Participants who completed the 12-month follow-up survey, which required them to survive, were included in this analysis.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing
|
19.6 percent
Interval 13.0 to 26.3
|
30.0 percent
Interval 22.2 to 37.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD
|
12.4 percent
Interval 6.2 to 18.6
|
13.7 percent
Interval 8.6 to 18.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsRespiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication
|
27.9 percent
Interval 21.5 to 34.4
|
25.2 percent
Interval 19.2 to 31.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment
|
12.3 percent
Interval 7.8 to 16.8
|
17.4 percent
Interval 11.8 to 23.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation
|
7.00 percent
Interval 2.9 to 11.2
|
6.40 percent
Interval 2.4 to 10.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.
|
90.8 percent
Interval 86.4 to 95.2
|
84.5 percent
Interval 79.4 to 89.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline who had complete follow-up data for all elements of the composite endpoints available were analyzed for this measure.
Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. OR 1\) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=25 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=49 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.
|
85.90 percent
Interval 73.93 to 97.87
|
83.37 percent
Interval 82.7 to 84.03
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing
|
24.19 percent
Interval 8.8 to 39.58
|
37.52 percent
Interval 24.67 to 50.37
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD
|
23.77 percent
Interval 8.8 to 38.74
|
24.62 percent
Interval 13.48 to 35.78
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication
|
30.22 percent
Interval 15.88 to 44.57
|
37.05 percent
Interval 26.73 to 47.37
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment
|
13.98 percent
Interval 0.36 to 27.61
|
21.58 percent
Interval 9.55 to 33.62
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.
|
10.16 percent
Interval -1.57 to 21.88
|
12.01 percent
Interval 2.62 to 21.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation
|
63.96 percent
Interval 44.78 to 83.15
|
71.98 percent
Interval 58.59 to 85.36
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline who had follow-up data available for referral information for smoking cessation programs were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=25 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=50 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program
|
40.70 percent
Interval 20.46 to 60.95
|
30.36 percent
Interval 16.69 to 44.03
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline who had follow-up data available for referral information for a smoking quit line were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=25 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=49 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line
|
59.54 percent
Interval 37.88 to 81.19
|
55.60 percent
Interval 39.32 to 71.88
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants currently smoking at baseline who had follow-up data for newly prescribed medication for smoking cessation were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=25 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=49 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.
|
55.90 percent
Interval 35.97 to 75.83
|
55.14 percent
Interval 40.73 to 69.55
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: There was missing data from 2 participants in the Enhanced Usual Care arm and missing data from 4 participants in the Intervention arm.
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=159 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=222 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants
|
-0.93 CAT score point scale
Interval -2.21 to 0.34
|
-1.25 CAT score point scale
Interval -2.33 to -0.18
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Experience Exacerbations.
|
15.3 percent
Interval 9.7 to 20.8
|
23.9 percent
Interval 17.2 to 30.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint) Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.
|
48.25 percent
Interval 31.56 to 64.94
|
50.05 percent
Interval 33.83 to 66.27
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing
|
23.04 percent
Interval 9.91 to 36.17
|
17.42 percent
Interval 5.72 to 29.13
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD
|
13.58 percent
Interval 2.18 to 24.97
|
24.26 percent
Interval 10.39 to 38.12
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication
|
38.42 percent
Interval 23.34 to 53.5
|
24.87 percent
Interval 11.58 to 38.16
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment
|
9.76 percent
Interval 0.72 to 18.8
|
10.14 percent
Interval 0.95 to 19.33
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.
|
12.61 percent
Interval 6.1 to 19.11
|
5.63 percent
Interval -0.79 to 12.06
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=39 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=40 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination
|
94.28 percent
Interval 85.74 to 102.82
|
93.22 percent
Interval 84.33 to 102.11
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.
|
36.2 percent
Interval 26.6 to 45.9
|
34.5 percent
Interval 24.1 to 44.8
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing
|
15.1 percent
Interval 9.1 to 21.2
|
17.4 percent
Interval 10.2 to 24.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.
|
10.1 percent
Interval 4.9 to 15.3
|
15.9 percent
Interval 9.4 to 22.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication
|
22.7 percent
Interval 16.1 to 29.3
|
19.8 percent
Interval 12.1 to 27.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment
|
8.1 percent
Interval 2.5 to 13.7
|
7.6 percent
Interval 2.3 to 12.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.
|
7.8 percent
Interval 3.6 to 12.0
|
4.0 percent
Interval 0.7 to 7.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=119 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=126 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.
|
89.8 percent
Interval 83.6 to 95.9
|
87.6 percent
Interval 81.4 to 93.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint
|
28.66 percent
Interval 17.13 to 40.2
|
27.02 percent
Interval 16.48 to 37.57
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing
|
11.16 percent
Interval 4.13 to 18.2
|
17.25 percent
Interval 9.16 to 25.34
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD With a New Diagnosis of COPD
|
8.45 percent
Interval 2.0 to 14.89
|
11.36 percent
Interval 4.38 to 18.34
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication
|
14.92 percent
Interval 6.87 to 22.97
|
17.29 percent
Interval 9.13 to 25.45
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment
|
5.53 percent
Interval -0.62 to 11.68
|
5.89 percent
Interval 0.03 to 11.74
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.
|
7.50 percent
Interval 1.72 to 13.27
|
3.49 percent
Interval -0.39 to 7.37
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=80 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=86 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.
|
87.07 percent
Interval 78.36 to 95.79
|
85.04 percent
Interval 76.43 to 93.64
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.
|
30.4 percent
Interval 24.3 to 36.4
|
30.4 percent
Interval 25.2 to 35.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.
|
15.9 percent
Interval 10.5 to 21.2
|
18.5 percent
Interval 14.1 to 22.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.
|
5.8 percent
Interval 2.5 to 9.2
|
7.4 percent
Interval 4.3 to 10.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication
|
17.5 percent
Interval 12.6 to 22.5
|
17.4 percent
Interval 12.9 to 21.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment
|
11.2 percent
Interval 7.5 to 14.9
|
13.4 percent
Interval 9.8 to 17.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.
|
4.6 percent
Interval 1.3 to 7.8
|
4.4 percent
Interval 1.9 to 7.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=189 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=271 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.
|
85.1 percent
Interval 78.9 to 91.4
|
85.2 percent
Interval 80.2 to 90.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC\<0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.
|
32.6 percent
Interval 23.9 to 41.3
|
28.4 percent
Interval 21.6 to 35.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.
|
14.9 percent
Interval 8.6 to 21.2
|
18.8 percent
Interval 13.1 to 24.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD
|
5.7 percent
Interval 1.7 to 9.6
|
4.8 percent
Interval 1.5 to 8.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication
|
21.0 percent
Interval 13.0 to 29.1
|
12.3 percent
Interval 7.1 to 17.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment
|
10.8 percent
Interval 5.9 to 15.7
|
6.0 percent
Interval 2.8 to 9.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.
|
5.0 percent
Interval 1.1 to 9.0
|
5.4 percent
Interval 1.6 to 9.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=127 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=186 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.
|
89.1 percent
Interval 83.2 to 95.0
|
80.4 percent
Interval 73.9 to 86.8
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Proportion of CAPTURE+ participants enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
36.04 percent
Interval 19.64 to 52.44
|
52.81 percent
Interval 41.97 to 63.65
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
Proportion of CAPTURE+ participants enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
42.0 percent
Interval 33.5 to 50.5
|
45.7 percent
Interval 36.9 to 54.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
|
18.45 percent
Interval -7.2 to 44.1
|
28.86 percent
Interval 13.7 to 44.02
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
|
19.6 percent
Interval 12.8 to 26.3
|
30.4 percent
Interval 21.2 to 39.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD
|
12.70 percent
Interval 3.46 to 21.93
|
13.11 percent
Interval 6.46 to 19.75
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD
|
12.1 percent
Interval 5.4 to 18.7
|
14.8 percent
Interval 8.5 to 21.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
|
22.79 percent
Interval 6.23 to 39.34
|
24.15 percent
Interval 14.09 to 34.21
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
|
28.4 percent
Interval 21.4 to 35.4
|
26.1 percent
Interval 19.2 to 33.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
7.30 percent
Interval -6.18 to 20.77
|
19.78 percent
Interval 8.65 to 30.91
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
12.7 percent
Interval 8.1 to 17.3
|
16.9 percent
Interval 10.5 to 23.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
|
6.06 percent
Interval -4.6 to 16.72
|
11.34 percent
Interval 3.31 to 19.37
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
|
6.8 percent
Interval 2.4 to 11.1
|
5.2 percent
Interval 1.0 to 9.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
|
95.39 percent
Interval 82.91 to 108.87
|
88.30 percent
Interval 78.14 to 98.46
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
|
89.9 percent
Interval 85.2 to 94.5
|
83.3 percent
Interval 77.7 to 89.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=29 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=53 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination
|
82.70 percent
Interval 69.16 to 96.24
|
71.66 percent
Interval 59.76 to 83.57
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019
|
-1.30 CAT score point scale
Interval -6.5 to 3.9
|
-2.44 CAT score point scale
Interval -5.08 to 0.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019
|
-0.92 CAT score point scale
Interval -2.28 to 0.44
|
-0.92 CAT score point scale
Interval -2.15 to 0.31
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations.
|
8.78 percent
Interval -2.61 to 20.18
|
26.62 percent
Interval 16.12 to 37.13
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations.
|
15.9 percent
Interval 10.0 to 21.7
|
23.7 percent
Interval 15.8 to 31.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed 1 year follow-up prior to the COVID-19 pandemic onset.
Proportion of participants with clinically significant COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
|
0 percent
Only one participant was in the Enhanced Usual Care group (insufficient data for confidence limits)
|
42.8 percent
Interval 6.2 to 79.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsProportion of participants with clinically significant COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
|
49.69 percent
Interval 32.76 to 66.63
|
51.76 percent
Interval 33.74 to 69.77
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed 1 year follow-up prior to the COVID-19 pandemic onset.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
|
0 percent
Only one participant was in the Enhanced Usual Care group (insufficient data for confidence limits)
|
14.3 percent
Interval 0.0 to 40.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
|
23.66 percent
Interval 10.19 to 37.14
|
18.14 percent
Interval 5.02 to 31.26
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
|
0 percent
Only one participant was in the Enhanced Usual Care group (insufficient data for confidence limits)
|
14.3 percent
Interval 0.0 to 40.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD
|
13.96 percent
Interval 2.28 to 25.65
|
26.62 percent
Interval 10.75 to 42.49
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
|
0 percent
Only one participant was in the Enhanced Usual Care group (insufficient data for confidence limits)
|
42.8 percent
Interval 6.2 to 79.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
|
39.33 percent
Interval 24.21 to 54.45
|
21.04 percent
Interval 7.4 to 34.68
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
|
0 percent
Only one participant was in the Enhanced Usual Care group (insufficient data for confidence limits)
|
14.3 percent
Interval 0.0 to 40.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
|
9.98 percent
Interval 0.75 to 19.21
|
9.31 percent
Interval -0.38 to 19.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program.
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
|
12.02 percent
Interval 5.03 to 19.01
|
6.54 percent
Interval -0.94 to 14.03
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Clinically significant COPD = post-bronchodilator FEV1/FVC \<0.7, plus: 1) FEV1 \< 60% predicted or 2) \> 1 exacerbation like event in the last year. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=1 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=7 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
|
100 percent
100% (1 out of 1 participants) received recommendations for or administration of influenza vaccine. In this case, the raw number of 100% is reported without corresponding (unavailable) confidence limits.
|
100 percent
100% (7 out of 7 participants) received recommendations for or administration of influenza vaccine. In this case, the raw number of 100% is reported without corresponding (unavailable) confidence limits.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=38 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=33 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination
|
94.00 percent
Interval 85.24 to 102.77
|
91.13 percent
Interval 79.88 to 102.39
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Proportion of participants with spirometric COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
|
29.18 percent
Interval 8.37 to 49.98
|
16.03 percent
Interval 0.59 to 31.46
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Proportion of participants with spirometric COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
|
37.2 percent
Interval 27.0 to 47.4
|
37.0 percent
Interval 25.7 to 48.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, subject will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
|
0 percent
0% (0 out of 8 participants) received referral for or completed of clinical spirometry testing. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
NA percent
Only 1 of 17 subjects was referred for or completed spirometry testing (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of spirometric COPD subjects in practices and potential correlation of outcomes between individuals in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
16.2 percent
Interval 10.0 to 22.4
|
19.3 percent
Interval 11.3 to 27.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
|
13.71 percent
Interval -5.55 to 32.96
|
5.10 percent
Interval -4.64 to 14.64
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
|
9.9 percent
Interval 4.4 to 15.4
|
17.5 percent
Interval 10.4 to 24.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
|
14.93 percent
Interval 0.12 to 29.73
|
15.75 percent
Interval 0.71 to 30.79
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
|
23.5 percent
Interval 16.4 to 30.6
|
20.1 percent
Interval 11.7 to 28.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, participant will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description)
|
0 percent
0% (0 out of 8 participants) were referred to a specialist for respiratory evaluation/treatment. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
NA percent
Only 1 of 17 subjects was referred for or completed spirometry testing (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of spirometric COPD subjects in practices and potential correlation of outcomes between individuals in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
8.7 percent
Interval 2.8 to 14.6
|
7.6 percent
Interval 1.9 to 13.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program.
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
|
8.4 percent
Interval 4.0 to 12.8
|
4.5 percent
Interval 0.8 to 8.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=8 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=17 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
|
88.42 percent
Interval 67.34 to 109.51
|
88.25 percent
Interval 73.23 to 103.27
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=111 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=109 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
|
90.1 percent
Interval 83.7 to 96.4
|
87.5 percent
Interval 80.6 to 94.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory Mild COPD = post-bronch FEV1/FVC\<0.7 plus 1) FEV1 ≥ 60% and 2) No prior COPD exacerbation The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) aren't based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcome between subjects in same practice
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab
|
NA percent
Only 2 out of 7 subjects were referred for or completed spirometry testing (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of spirometric COPD subjects in practices and potential correlation of outcomes between subjects in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
0 percent
0% (0 out of 10 participants) met the components of the primary endpoint. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Proportion of participants with mild COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
|
28.9 percent
Interval 18.7 to 39.1
|
30.8 percent
Interval 17.9 to 43.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Mild COPD = post-bronch FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
|
0 percent
0% of participants in this analysis were referred for or competition of spirometry testing. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
0 percent
0% of participants in this analysis were referred for or competition of spirometry testing. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
12.5 percent
Interval 6.2 to 18.9
|
20.1 percent
Interval 10.3 to 29.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
|
NA percent
Only 1 subject was referred for or completed spirometry testing (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of spirometric COPD subjects in practices and potential correlation of outcomes between individuals in the same practice and aren't reported. In general, raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
0 percent
0% of participants in this analysis received a new diagnosis of COPD In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
|
7.9 percent
Interval 1.9 to 13.9
|
12.8 percent
Interval 4.3 to 21.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and c
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description)
|
NA percent
Only 1 out of 7 subjects was referred for or completed spirometry testing (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of spirometric COPD subjects in practices and potential correlation of outcomes between individuals in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
0 percent
0% (0 out of 10 participants) received referral for or completed of clinical spirometry testing. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
|
15.0 percent
Interval 8.2 to 21.9
|
19.6 percent
Interval 9.2 to 30.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
0 percent
No participants were referred to a respiratory specialist (insufficient for model convergence).
|
0 percent
No participants were referred to a respiratory specialist (insufficient for model convergence).
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
6.1 percent
Interval 0.6 to 11.5
|
6.7 percent
Interval 0.3 to 13.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program (insufficient for model convergence).
|
0 percent
No participants were referred for or competition of pulmonary rehabilitation program (insufficient for model convergence).
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
8.2 percent
Interval 1.8 to 14.7
|
4.0 percent
Interval -0.2 to 8.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=7 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=10 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
|
82.7 percent
Interval 50.04 to 115.35
|
77.75 percent
Interval 49.8 to 105.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=73 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=76 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
|
87.4 percent
Interval 77.2 to 97.7
|
86.3 percent
Interval 77.7 to 94.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
66.7 percent
Interval 35.3 to 98.0
|
29.03 percent
Interval 15.4 to 42.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
28.8 percent
Interval 23.1 to 34.6
|
31.2 percent
Interval 25.7 to 36.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
41.27 percent
Interval 16.95 to 65.6
|
18.21 percent
Interval 17.49 to 18.93
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
14.4 percent
Interval 9.3 to 19.6
|
17.6 percent
Interval 12.6 to 22.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD
|
9.05 percent
Interval -6.59 to 24.68
|
7.33 percent
Interval 1.99 to 12.67
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD
|
5.5 percent
Interval 2.2 to 8.8
|
7.5 percent
Interval 4.0 to 11.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
|
55.27 percent
Interval 24.42 to 86.12
|
13.17 percent
Interval 4.04 to 22.31
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
|
15.8 percent
Interval 11.4 to 20.3
|
18.3 percent
Interval 13.3 to 23.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
29.87 percent
Interval 5.46 to 54.27
|
17.60 percent
Interval 10.39 to 24.81
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
10.2 percent
Interval 6.6 to 13.7
|
12.6 percent
Interval 8.4 to 16.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
0 percent
No participants were referred for competition of pulmonary rehabilitation program (insufficient for model convergence) in the Enhanced Usual Care Arm.
|
NA percent
Only 4 participants were referred for competition of pulmonary rehabilitation program (insufficient for model convergence) in the Intervention Arm.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
4.7 percent
Interval 1.4 to 8.0
|
3.5 percent
Interval 0.8 to 6.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Preserved ratio, impaired spirometry (PRISm) = participants without spirometrically defined COPD who have post-bronch FEV1 \< 80% predicted. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=9 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=45 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
|
100 percent
100% (9 out of 9 participants) received recommendations for or administration of influenza vaccine. In this case, the raw number of 100% is reported without corresponding (unavailable) confidence limits.
|
NA percent
Only 5 of 45 subjects didn't receive a recommendation for the vaccine (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of vaccine administration in practices and potential correlation of outcomes between individuals in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=180 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
|
84.3 percent
Interval 77.8 to 90.9
|
84.7 percent
Interval 79.2 to 90.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
35.2 percent
Interval 33.2 to 37.1
|
35.8 percent
Interval 23.1 to 48.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
|
33.7 percent
Interval 23.5 to 43.9
|
25.5 percent
Interval 16.2 to 34.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
25.1 percent
Interval 21.7 to 28.5
|
21.7 percent
Interval 13.1 to 30.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
|
13.1 percent
Interval 6.1 to 20.2
|
17.1 percent
Interval 9.6 to 24.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
SNO = post-bronch FEV1/FVC ≥ 0.7 and post-bronch FEV1 ≥ 80% predicted and a COPD Assessment Test (CAT) score ≥ 10. The CAT is scored 0-40. Higher score = more severe COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits not based on raw data proportions. Reported units are on the scale from 0% - 100%. Ie. 50 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie 10 = Intervention met outcome 10% \> EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
|
0 percent
0% (0 of 20 participants) received a new diagnosis of COPD. In this case, the raw number of 0% is reported without corresponding (unavailable) confidence limits.
|
NA percent
Only 4 of 74 participants received a new diagnosis of COPD (insufficient for GEE model convergence). Raw proportions don't sufficiently account for different numbers of new COPD diagnoses in practices, and potential correlation of outcomes between individuals in the same practice and aren't reported. Raw proportions and corresponding GEE based model estimates for these proportions aren't equivalent in cluster randomized trials with different sample sizes in each cluster.
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
|
6.7 percent
Interval 2.2 to 11.1
|
4.4 percent
Interval 0.2 to 8.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication
|
15.2 percent
Interval -3.5 to 33.8
|
14.8 percent
Interval 7.8 to 21.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 were analyzed for this measure.
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication
|
22.7 percent
Interval 13.6 to 31.8
|
10.6 percent
Interval 3.7 to 17.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
9.9 percent
Interval 8.5 to 11.2
|
8.1 percent
Interval 4.3 to 11.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
|
11.7 percent
Interval 5.5 to 18.0
|
4.5 percent
Interval 0.1 to 8.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
5.0 percent
Interval -1.2 to 11.3
|
4.1 percent
Interval -0.7 to 8.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
|
5.6 percent
Interval 0.7 to 10.4
|
6.2 percent
Interval 0.8 to 11.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=74 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
|
94.8 percent
Interval 88.6 to 101.0
|
87.4 percent
Interval 79.6 to 95.1
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=107 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=112 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
|
88.2 percent
Interval 81.7 to 94.8
|
77.0 percent
Interval 68.6 to 85.4
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only Capture positive participants currently smoking at baseline who had follow-up data available for over-the-counter patches/gum cessation programs were analyzed for this measure.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=25 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=49 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation
|
56.18 percent
Interval 37.39 to 74.98
|
41.52 percent
Interval 28.48 to 54.57
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsCAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=161 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=226 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Who Experience Hospitalizations
Hospitalized for respiratory illness during follow-up
|
2 Participants
|
4 Participants
|
|
Proportion of CAPTURE+ Participants Who Experience Hospitalizations
No hospitalized for respiratory illness during follow-up
|
158 Participants
|
221 Participants
|
|
Proportion of CAPTURE+ Participants Who Experience Hospitalizations
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Analysis population is CAPTURE positive participants selected for follow-up. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=225 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=331 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Number of Enrolled CAPTURE+ Participants Who Experience Mortality
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=13 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=46 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations
|
0.0 percent
No patients were hospitalized for respiratory illnesses (insufficient variability for confidence limits).
|
0.0 percent
No patients were hospitalized for respiratory illnesses (insufficient variability for confidence limits).
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=148 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=180 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations
|
1.5 percent
Interval -0.3 to 3.4
|
2.1 percent
Interval 0.1 to 4.2
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Analysis population is CAPTURE positive participants selected for follow-up and enrolled prior to March 20, 2019. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=20 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=72 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Analysis population is CAPTURE positive participants selected for follow-up and enrolled after March 20, 2019. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Outcome measures
| Measure |
Enhanced Usual Care Arm: COPD Education
n=205 Participants
Practice clinicians received basic COPD education only.
|
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
n=259 Participants
Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results.
|
|---|---|---|
|
Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality.
|
2 Participants
|
2 Participants
|
Adverse Events
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results
Enhanced Usual Care Arm: COPD Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place