Trial Outcomes & Findings for De-implementing Inhaled Steroids to Improve Care and Safety in COPD (NCT NCT02896257)

Last Updated: 2023-07-27

Results Overview

Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.

Recruitment status

COMPLETED

Study phase

Target enrollment

181 participants

Primary outcome timeframe

Assessed at 6 months post primary care visit defined as (index date + 180 days)

Results posted on

2023-07-27

Participant Flow

Prior to study start, we stratified all primary care teams based on site, provider type, and median number of eligible patients. Primary care teams were the unit of randomization, and providers were randomized along with their primary care team in a 1:1 ratio. For new providers, the unit of randomization was at the level of the PCP (stratified by site, provider type and median number of eligible patients).Only PCPs were considered enrolled. Patients were not considered enrolled in this study.

Prior to study start, we identified 139 primary care teams eligible for randomization; 2 primary care teams lost their associated provider prior to study start, leaving 137 primary care teams for initial randomization. Periodically, the Corporate Data Warehouse was queried to determine active primary care providers(PCPs) and their care teams. New PCPs and new care teams were added, resulting in a total of 220 distinct PCP-primary care team combinations.

Unit of analysis: PCP-Primary Care Teams

Participant milestones

Participant milestones
Measure	Usual Care Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Providers STARTED	88 111	93 109
Providers PCPs Assigned to 1 Primary Care Team	68 68	79 79
Providers PCPs Assigned to Two Primary Care Teams	18 36	12 24
Providers PCPs Assigned to 3 Primary Care Teams	1 3	2 6
Providers PCPs Assigned to Four Primary Care Teams	1 4	0 0
Providers COMPLETED	67 76	65 72
Providers NOT COMPLETED	21 35	28 37
Patients STARTED	344 111	342 109
Patients COMPLETED	281 76	269 72
Patients NOT COMPLETED	63 35	73 37

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Providers Without eligible patients	21	28
Patients PFT entry criteria not met	43	50
Patients No capacity to review	8	11
Patients Appointment rescheduled/cancelled	5	7
Patients PCP not assigned a clinic	4	0
Patients No history of COPD	0	1
Patients Deceased between review and index date	0	1
Patients No ICS Rx upon review	1	1
Patients Protocol Violation	2	1
Patients Hospice care	0	1

Baseline Characteristics

Data not collected from providers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Patients n=281 Participants Standard practice (usual care). Primary care providers treat their patients as usual.	Intervention Patients n=269 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.	Usual Care Providers n=88 Participants Standard practice (usual care). Primary care providers treat their patients as usual.	Intervention Providers n=93 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.	Total n=731 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=281 Participants • Data not collected from providers.	0 Participants n=269 Participants • Data not collected from providers.	—	—	0 Participants n=550 Participants • Data not collected from providers.
Age, Categorical Between 18 and 65 years	75 Participants n=281 Participants • Data not collected from providers.	58 Participants n=269 Participants • Data not collected from providers.	—	—	133 Participants n=550 Participants • Data not collected from providers.
Age, Categorical >=65 years	206 Participants n=281 Participants • Data not collected from providers.	211 Participants n=269 Participants • Data not collected from providers.	—	—	417 Participants n=550 Participants • Data not collected from providers.
Age, Continuous	69.1 years STANDARD_DEVIATION 8.8 • n=281 Participants • Data not collected from providers.	70.7 years STANDARD_DEVIATION 9.0 • n=269 Participants • Data not collected from providers.	—	—	69.9 years STANDARD_DEVIATION 8.9 • n=550 Participants • Data not collected from providers.
Sex: Female, Male Female	7 Participants n=281 Participants • Data not collected from providers.	5 Participants n=269 Participants • Data not collected from providers.	—	—	12 Participants n=550 Participants • Data not collected from providers.
Sex: Female, Male Male	274 Participants n=281 Participants • Data not collected from providers.	264 Participants n=269 Participants • Data not collected from providers.	—	—	538 Participants n=550 Participants • Data not collected from providers.
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=281 Participants • Data not collected from providers.	5 Participants n=269 Participants • Data not collected from providers.	—	—	9 Participants n=550 Participants • Data not collected from providers.
Ethnicity (NIH/OMB) Not Hispanic or Latino	271 Participants n=281 Participants • Data not collected from providers.	257 Participants n=269 Participants • Data not collected from providers.	—	—	528 Participants n=550 Participants • Data not collected from providers.
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=281 Participants • Data not collected from providers.	7 Participants n=269 Participants • Data not collected from providers.	—	—	13 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=281 Participants • Data not collected from providers.	5 Participants n=269 Participants • Data not collected from providers.	—	—	7 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) Asian	1 Participants n=281 Participants • Data not collected from providers.	1 Participants n=269 Participants • Data not collected from providers.	—	—	2 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=281 Participants • Data not collected from providers.	1 Participants n=269 Participants • Data not collected from providers.	—	—	5 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) Black or African American	15 Participants n=281 Participants • Data not collected from providers.	12 Participants n=269 Participants • Data not collected from providers.	—	—	27 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) White	244 Participants n=281 Participants • Data not collected from providers.	227 Participants n=269 Participants • Data not collected from providers.	—	—	471 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) More than one race	0 Participants n=281 Participants • Data not collected from providers.	0 Participants n=269 Participants • Data not collected from providers.	—	—	0 Participants n=550 Participants • Data not collected from providers.
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=281 Participants • Data not collected from providers.	23 Participants n=269 Participants • Data not collected from providers.	—	—	38 Participants n=550 Participants • Data not collected from providers.
Region of Enrollment United States	281 Participants n=281 Participants • Data not collected from providers.	269 Participants n=269 Participants • Data not collected from providers.	—	—	550 Participants n=550 Participants • Data not collected from providers.
Smoking Former or Never Smoker	155 Participants n=281 Participants • Data not collected from providers.	162 Participants n=269 Participants • Data not collected from providers.	—	—	317 Participants n=550 Participants • Data not collected from providers.
Smoking Current Smoker	115 Participants n=281 Participants • Data not collected from providers.	93 Participants n=269 Participants • Data not collected from providers.	—	—	208 Participants n=550 Participants • Data not collected from providers.
Smoking Missing	11 Participants n=281 Participants • Data not collected from providers.	14 Participants n=269 Participants • Data not collected from providers.	—	—	25 Participants n=550 Participants • Data not collected from providers.
Provider type Physicians	—	—	57 Participants n=88 Participants • Data not applicable to patient participants.	60 Participants n=93 Participants • Data not applicable to patient participants.	117 Participants n=181 Participants • Data not applicable to patient participants.
Provider type Advanced Practice Providers	—	—	31 Participants n=88 Participants • Data not applicable to patient participants.	33 Participants n=93 Participants • Data not applicable to patient participants.	64 Participants n=181 Participants • Data not applicable to patient participants.
Site Site 1	67 Participants n=281 Participants	57 Participants n=269 Participants	12 Participants n=88 Participants	12 Participants n=93 Participants	148 Participants n=731 Participants
Site Site 2	214 Participants n=281 Participants	212 Participants n=269 Participants	76 Participants n=88 Participants	81 Participants n=93 Participants	583 Participants n=731 Participants
Mean number of eligible patients	—	—	4.0 number of patients STANDARD_DEVIATION 3.5 • n=88 Participants • Data not applicable to patient participants.	4.1 number of patients STANDARD_DEVIATION 3.6 • n=93 Participants • Data not applicable to patient participants.	4.1 number of patients STANDARD_DEVIATION 3.5 • n=181 Participants • Data not applicable to patient participants.

PRIMARY outcome

Timeframe: Assessed at 6 months post primary care visit defined as (index date + 180 days)

Population: Patient participants that are assigned to usual care or intervention primary care providers.

Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.

Outcome measures

Outcome measures
Measure	Usual Care n=281 Participants Primary care providers treat their patients as usual.	Intervention n=269 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.	94 Participants	174 Participants

SECONDARY outcome

Timeframe: Within 6 months defined as (index date +1 day) to (index date + 180 days)

Population: Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.

Rate of COPD exacerbation within 6 months starting the day after index date.

Outcome measures

Outcome measures
Measure	Usual Care n=281 Participants Primary care providers treat their patients as usual.	Intervention n=268 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Rate of COPD Exacerbation	0.11 Events per 6 months of person-time	0.09 Events per 6 months of person-time

SECONDARY outcome

Timeframe: Within 6 months defined as (index date +1 day) to (index date + 180 days)

Rate of pneumonia within 6 months starting the day after index date.

Outcome measures

Outcome measures
Measure	Usual Care n=281 Participants Primary care providers treat their patients as usual.	Intervention n=268 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Rate of Pneumonia	0.03 Events per 6 months of person-time	0.02 Events per 6 months of person-time

SECONDARY outcome

Timeframe: Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)

Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)

Outcome measures

Outcome measures
Measure	Usual Care n=281 Participants Primary care providers treat their patients as usual.	Intervention n=268 Participants Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Mortality	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Collected at time of recommendation/order entry

Population: Patient participants assigned to intervention PCPs.

Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids

Outcome measures

Outcome measures
Measure	Usual Care n=269 Participants Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Number of Patients Recommended to Stop Inhaled Corticosteroids	181 Participants	—

SECONDARY outcome

Timeframe: Assessed during 6 months following index date

Population: Recommendations to discontinue inhaled corticosteroids. A recommendation to discontinue inhaled corticosteroids was made only once per patient.

Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers

Outcome measures

Outcome measures
Measure	Usual Care n=181 Participants Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers	92.3 Percentage of recommendations	—

SECONDARY outcome

Timeframe: Assessed at 6 months post index date

Population: Patients where ICS discontinuation recommendation was accepted.

Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date

Outcome measures

Outcome measures
Measure	Usual Care n=167 Participants Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date	24 Participants	—

SECONDARY outcome

Timeframe: Collected at time or recommendation order entry

Population: We identified 269 patients meeting entry and exclusion criteria cared for by a primary care provider assigned to the intervention group. Of these, 262 received an electronic consult with recommendations for guideline concordant COPD care.

Among patients assigned to intervention providers, number of patients for whom recommendations are made.

Outcome measures

Outcome measures
Measure	Usual Care n=269 Participants Primary care providers treat their patients as usual.	Intervention Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Number of Patients for Whom Recommendations Are Made	262 Participants	—

Adverse Events

Usual Care

Serious events: 41 serious events

Other events: 0 other events

Deaths: 9 deaths

Intervention

Serious events: 30 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care n=281 participants at risk Standard practice (usual care). Primary care providers treat their patients as usual.	Intervention n=269 participants at risk Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids. Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
Respiratory, thoracic and mediastinal disorders Inpatient COPD Exacerbation	2.1% 6/281 • 6 months Adverse events were not collected from providers.	2.6% 7/269 • 6 months Adverse events were not collected from providers.
Respiratory, thoracic and mediastinal disorders Outpatient COPD Exacerbation	10.7% 30/281 • 6 months Adverse events were not collected from providers.	8.6% 23/269 • 6 months Adverse events were not collected from providers.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.8% 8/281 • 6 months Adverse events were not collected from providers.	1.9% 5/269 • 6 months Adverse events were not collected from providers.

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Au

VA Puget Sound Health Care System

Phone: 206-764-2504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place