DISCUSS COPD: De-implementing Inhaled Steroids to Improve Care and Safety in COPD

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02896257
• Collaborator: (none)
• Enrollment: 181
• Locations: 2
• Arms: 2
• Actual Duration (Months): 57.8
• Patients Per Site: 90.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This Quality Enhancement Research Initiative (QuERI) project is designed to determine efficacy and acceptance of an intervention method to provide primary care providers with patient-tailored electronic consults and corresponding unsigned orders for de-implementation of inhaled corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.

Condition or Disease	Intervention/Treatment	Phase
Treatment of Chronic Obstructive Pulmonary Disease	Other: Guideline treatment recommendations	N/A

Detailed Description

Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. Approximately half of those who carry a diagnosis of COPD are prescribed inhaled corticosteroids (ICS), despite ICS having no role among those patients without fixed airflow obstruction (AFO) and a limited role among those who do. Guidelines explicitly state that ICS for COPD patients should be limited to those with severe AFO and those with frequent exacerbations. Even this benefit comes at a cost, as ICS use has been shown in multiple randomized controlled trials to increase rates of pneumonia. After prolonged exposure, ICS is also associated with higher bone fracture risk, incidence of cataracts and poor diabetes control. Among patients without disease or with mild-moderate AFO and low risk of exacerbation, ICS have no demonstrated efficacy, but retain the risk of harm. For this reason, evidence-based guidelines specifically recommend against their use in mild-moderate AFO.

The goal of this project is to improve the delivery and safety of care by de-implementing the ineffective use of ICS among Veterans with a diagnosis of COPD who otherwise lack a clinical indication for the medication. The primary aim is to reduce ICS use among Veterans with limited clinical indication for the medication. Investigators will test an intervention to de-implement unnecessary use of inhaled corticosteroids in Veterans with chronic obstructive pulmonary disease (COPD) by having pulmonologists assume more responsibility for supporting COPD patients. The investigators will compare a substitution approach using proactive patient-tailored electronic consult (E-consult) compared to usual care with a single-session education outreach, which represents a non-intensive unlearning approach. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to either receive the intervention or not receive the intervention. For patients within intervention PACTs, the project clinicians will leverage the VA's integrated healthcare informatics system using specialist support through proactive patient-tailored electronic consults (E-consult) and inputting unsigned orders on behalf of Primary Care Providers (PCPs) to recommend and facilitate de-implementation of ICS. Primary care providers will have final say in accepting (signing), modifying, or declining the recommendations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-271)
• Actual Study Start Date: Sep 6, 2016
• Actual Primary Completion Date: Jul 29, 2019
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Proactive patient-tailored electronic consult (E-consult) Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.	Other: Guideline treatment recommendations; Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
No Intervention: Usual care Standard practice (usual care). Primary care providers treat their patients as usual.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. [Assessed at 6 months post primary care visit defined as (index date + 180 days)]

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

Secondary Outcome Measures

1. Rate of COPD Exacerbation [Within 6 months defined as (index date +1 day) to (index date + 180 days)]

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

2. Rate of Pneumonia [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.

3. Mortality [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)

4. Number of Patients Recommended to Stop Inhaled Corticosteroids [Collected at time of recommendation/order entry]

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

5. Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers [Assessed during 6 months following index date]

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

6. Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date [Assessed at 6 months post index date]

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

7. Number of Patients for Whom Recommendations Are Made [Collected at time or recommendation order entry]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Provider:

Primary care provider (medical doctor/osteopathic physician, nurse practitioner, physician assistant [MD/DO, NP, PA]) assigned to a PACT from VA Puget Sound Health Care System or Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA).

Patient:

• Patient is a Veteran who is assigned a VA PCP and has received Rx for an inhaled corticosteroid within the past 180 days.

• Patient has an inpatient or outpatient diagnosis of COPD in the prior two years.

• Patient has undergone spirometry in the past 5 years that indicates either no airflow obstruction or mild to moderate airflow obstruction indicated by a forced expiratory volume 1 (FEV1)/[greater of forced vital capacity (FVC) or vital capacity (VC)] =< 0.7 & FEV1% predicted >= 30%.

Exclusion Criteria:

Patients:

• Very severe airflow obstruction (<30% FEV1 % predicted)

• Severe disease as indicated by 1 inpatient COPD exacerbation in the year prior

• Severe disease as indicated by 2 outpatient COPD exacerbations in the year prior

• International Classification of Diseases (ICD) 9 and/or 10 diagnosed or clinically indicated asthmatics

• Significant bronchodilator response on spirometry (>12% increase in FEV1 post bronchodilator; >375 mL post-bronchodilator improvement)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts	United States	01730
2	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: David H. Au, MD MS, VA Puget Sound Health Care System Seattle Division, Seattle, WA
• Principal Investigator: Laura Feemster, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 1, 2021

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02896257
• Other Study ID Numbers: QUX 16-009; QUE 15-271
• First Posted: Sep 12, 2016
• Last Update Posted: Jan 5, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Quality Improvement; Quality Enhancement Research Initiatives; QuERI; Interventional; Multicenter; Inhaled corticosteroids; Pneumonia; Safety; De-implementation; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Diseases, Chronic Obstructive COPD
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Recruitment Details

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.

Pre-assignment Detail

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.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Primary care providers treat their patients as usual.	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Period Title: Providers
STARTED	88	93
PCPs Assigned to 1 Primary Care Team	68	79
PCPs Assigned to Two Primary Care Teams	18	12
PCPs Assigned to 3 Primary Care Teams	1	2
PCPs Assigned to Four Primary Care Teams	1	0
COMPLETED	67	65
NOT COMPLETED	21	28
Period Title: Providers
STARTED	344	342
COMPLETED	281	269
NOT COMPLETED	63	73

Baseline Characteristics

Arm/Group Title	Usual Care Patients	Intervention Patients	Usual Care Providers	Intervention Providers	Total
Arm/Group Description	Standard practice (usual care). Primary care providers treat their patients as usual.	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.	Standard practice (usual care). Primary care providers treat their patients as usual.	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 of all reporting groups
Overall Participants	281	269	88	93	731
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	75 26.7%	58 21.6%	133 151.1%
>=65 years	206 73.3%	211 78.4%	417 473.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.1 (8.8)	70.7 (9.0)	69.9 (8.9)
Sex: Female, Male (Count of Participants)
Female	7 2.5%	5 1.9%	12 13.6%
Male	274 97.5%	264 98.1%	538 611.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 1.4%	5 1.9%	9 10.2%
Not Hispanic or Latino	271 96.4%	257 95.5%	528 600%
Unknown or Not Reported	6 2.1%	7 2.6%	13 14.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%	5 1.9%	7 8%
Asian	1 0.4%	1 0.4%	2 2.3%
Native Hawaiian or Other Pacific Islander	4 1.4%	1 0.4%	5 5.7%
Black or African American	15 5.3%	12 4.5%	27 30.7%
White	244 86.8%	227 84.4%	471 535.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	15 5.3%	23 8.6%	38 43.2%
Region of Enrollment (Count of Participants)
United States	281 100%	269 100%	550 625%
Smoking (Count of Participants)
Former or Never Smoker	155 55.2%	162 60.2%	317 360.2%
Current Smoker	115 40.9%	93 34.6%	208 236.4%
Missing	11 3.9%	14 5.2%	25 28.4%
Provider type (Count of Participants)
Physicians	57 20.3%	60 22.3%	117 133%
Advanced Practice Providers	31 11%	33 12.3%	64 72.7%
Site (Count of Participants)
Site 1	67 23.8%	57 21.2%	12 13.6%	12 12.9%	148 20.2%
Site 2	214 76.2%	212 78.8%	76 86.4%	81 87.1%	583 79.8%
Mean number of eligible patients (number of patients) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of patients]	4.0 (3.5)	4.1 (3.6)	4.1 (3.5)

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.
Description	Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.
Time Frame	Assessed at 6 months post primary care visit defined as (index date + 180 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Primary care providers treat their patients as usual.	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	281	269
Count of Participants [Participants]	94 33.5%	174 64.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments	Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.66
	Confidence Interval	(2-Sided) 95%; 2.50 to 5.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Rate of COPD Exacerbation
Description	Rate of COPD exacerbation within 6 months starting the day after index date.
Time Frame	Within 6 months defined as (index date +1 day) to (index date + 180 days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Primary care providers treat their patients as usual.	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	281	268
Number [Events per 6 months of person-time]	0.11	0.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Regression, Logistic
	Comments	Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.44 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Rate of Pneumonia
Description	Rate of pneumonia within 6 months starting the day after index date.
Time Frame	Within 6 months defined as (index date +1 day) to (index date + 180 days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Primary care providers treat their patients as usual.	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	281	268
Number [Events per 6 months of person-time]	0.03	0.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Regression, Logistic
	Comments	Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; 0.20 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mortality
Description	Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)
Time Frame	Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Primary care providers treat their patients as usual.	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	281	268
Count of Participants [Participants]	9 3.2%	10 3.7%

5. Secondary Outcome

Title	Number of Patients Recommended to Stop Inhaled Corticosteroids
Description	Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
Time Frame	Collected at time of recommendation/order entry

Outcome Measure Data

Analysis Population Description

Patient participants assigned to intervention PCPs.

Arm/Group Title	Intervention
Arm/Group Description	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	269
Count of Participants [Participants]	181 64.4%

6. Secondary Outcome

Title	Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers
Description	Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers
Time Frame	Assessed during 6 months following index date

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention
Arm/Group Description	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	181
Number [Percentage of recommendations]	92.3

7. Secondary Outcome

Title	Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date
Description	Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date
Time Frame	Assessed at 6 months post index date

Outcome Measure Data

Analysis Population Description

Patients where ICS discontinuation recommendation was accepted.

Arm/Group Title	Intervention
Arm/Group Description	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	167
Count of Participants [Participants]	24 8.5%

8. Secondary Outcome

Title	Number of Patients for Whom Recommendations Are Made
Description	Among patients assigned to intervention providers, number of patients for whom recommendations are made.
Time Frame	Collected at time or recommendation order entry

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention
Arm/Group Description	Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Measure Participants	269
Count of Participants [Participants]	262 93.2%

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Adverse events were not collected from providers.
Arm/Group Title	Usual Care		Intervention
Arm/Group Description	Standard practice (usual care). Primary care providers treat their patients as usual.		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.
All Cause Mortality
	Usual Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/281 (3.2%)		10/269 (3.7%)
Serious Adverse Events
	Usual Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/281 (14.6%)		30/269 (11.2%)
Respiratory, thoracic and mediastinal disorders
Inpatient COPD Exacerbation	6/281 (2.1%)		7/269 (2.6%)
Outpatient COPD Exacerbation	30/281 (10.7%)		23/269 (8.6%)
Pneumonia	8/281 (2.8%)		5/269 (1.9%)
Other (Not Including Serious) Adverse Events
	Usual Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/281 (0%)		0/269 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.