Trial Outcomes & Findings for Promoting Veteran-Centered Colorectal Cancer Screening (NCT NCT02027545)
NCT ID: NCT02027545
Last Updated: 2023-05-03
Results Overview
The primary dependent variable in the analysis was whether screening was ordered within two weeks after the clinic visit (dichotomous). Screening orders were determined by manual record review of electronic health records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
436 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Decision Aid
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
175
|
|
Overall Study
COMPLETED
|
258
|
173
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Decision Aid
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
|---|---|---|
|
Overall Study
Failed to sign HIPAA
|
0
|
2
|
|
Overall Study
Failed to attend study visit
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Promoting Veteran-Centered Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Decision Aid
n=258 Participants
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
n=173 Participants
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
253 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
226 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Indian or Alaskan Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
258 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Prior Screening
None
|
50 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Prior Screening
FOBT/FIT
|
165 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Prior Screening
Colonoscopy
|
43 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 0-4.9
|
69 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 5-9.9
|
86 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 10-14.9
|
57 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 15-19.9
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 20-24.9
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 25-29.9
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Screening Benefit
Participants with Screening Benefit 30-35.0
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Mean Benefit from Screening
|
11.3 Cancers prevented per 1,000 pts screened
STANDARD_DEVIATION 8.1 • n=5 Participants
|
11.3 Cancers prevented per 1,000 pts screened
STANDARD_DEVIATION 8.0 • n=7 Participants
|
11.3 Cancers prevented per 1,000 pts screened
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Marital Status
Married
|
162 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Marital Status
Separated/Divorced
|
54 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Marital Status
Never Married
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Marital Status
Missing
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
Did not complete high school
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Education
High school/GED
|
80 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Education
Vocational, technical, or business training
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Education
1-3 years of college
|
80 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Education
Graduated college or 4 or more years of college
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Education
Graduate or professional school
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
Missing
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThe primary dependent variable in the analysis was whether screening was ordered within two weeks after the clinic visit (dichotomous). Screening orders were determined by manual record review of electronic health records.
Outcome measures
| Measure |
Decision Aid
n=258 Participants
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
n=173 Participants
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
|---|---|---|
|
Number of Participants With CRC Screening Ordered
|
162 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 2 weeksDefined as the degree to which screening orders align with expected screening benefit, such that individuals with low screening benefit receive screening orders at a lower rate than those with high screening benefit. We hypothesized that Veterans randomized to the intervention (decision aid) would receive screening orders that were more concordant with screening benefit than those randomized to the control. The expected benefit of screening (reduction in CRC incidence) was calculated using the MISCAN-Colon model. For a given patient, this value was a function of age, gender, health status, and prior screening history. The regression analysis included screening orders as the dependent variable, and, study arm, expected benefit, and an interaction term between study arm and expected benefit as the independent variables. The p-value reported is for the interaction term.
Outcome measures
| Measure |
Decision Aid
n=258 Participants
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
n=173 Participants
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
|---|---|---|
|
Concordance Between Screening Orders and Screening Benefit
|
162 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 6 monthsScreening test completion was collected through manual review of electronic medical records.
Outcome measures
| Measure |
Decision Aid
n=256 Participants
Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.
1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
No Decision Aid
n=173 Participants
Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.
1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.
|
|---|---|---|
|
Number of Participants With CRC Screening Utilized
|
106 Participants
|
96 Participants
|
Adverse Events
Decision Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Decision Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sameer D. Saini, MD, MS
VA Ann Arbor Healthcare System
Phone: 734-845-5865
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place