Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD

Study Overview
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Brief Summary
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Background: Over 26 million Americans have chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in the United States. Unfortunately, few patients receive proven therapies and many receive therapies known to have safer alternatives. One major reason is the competing demands of primary care providers (PCPs) who manage 90% of patients with COPD. The research team has developed a population management approach where pulmonary specialists provide evidence-based recommendations as an E-consult with unsigned orders to PCPs. PCPs can then quickly review the E-consult and sign, modify, or discontinue these orders. The investigators found this intervention led to marked improvements in the quality-of-care delivered and patients' COPD-related quality-of-life. While promising, this approach is limited by a paucity of pulmonary providers nationwide. Clinical pharmacists are 20 times more prevalent as pulmonary specialists and some regions of VA (VISN 17, COPD Cares) have assigned clinical pharmacists a role in the management of patients with COPD. However, the relative effectiveness of pharmacist-led management is yet to be established. Study Description: This study tests population management for COPD provided by pharmacists relative to pulmonary specialists. The investigators are conducting a cluster randomized clinical trial at five medical centers and their associated clinics within the Department of Veterans Affair. Study staff will randomize PCPs to population management conducted by either pulmonary specialists or pharmacists. Within PCPs' panels, study staff will use VA electronic health record to identify patients with evidence of COPD. Pulmonologists and pharmacists will review these patients and provide guideline-based recommendations to PCPs. Pulmonary specialists and pharmacists will then deliver evidence-based recommendations through E-consults coupled with unsigned orders for primary care providers to sign, modify or decline. Outcomes: Investigators will assess if proactive, population management recommendations by clinical pharmacists and pulmonary specialists lead to non-inferior outcomes for patients with COPD. The primary outcome will be a composite endpoint of COPD exacerbation, pneumonia, hospitalization, or death six month after intervention. Secondary outcomes will include 1) the proportion of guideline recommended therapies received by patients, 2) COPD-related quality-of-life as measured by the Clinical COPD Questionnaire, and 3) PCP acceptance of recommendations, and 4) each individual outcome within the primary composite endpoint above.

Official Title
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Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Population-health management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants may be PCP physicians and advance practice providers (APP) practicing at participating sites, and their patients who are diagnosed with or treated for COPD based on the following criteria: Recent discharge from hospital for COPD exacerbation Recent outpatient exacerbation (emergency room (ER), primary care) Received prescription for an inhaled corticosteroid (ICS) but does not meet criteria for ICS use Diagnosis of COPD and/or treatment and active smoker not receiving smoking cessation aide Treatment for COPD without evidence of spirometry within 10 years, or no airflow obstruction on existing spirometry
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacist led<br>Pharmacists will conduct population health management for patients with COPD | Other: Population-health management<br>* Population-health management<br>|
| Active Comparator: Pulmonologist led<br>Pulmonologists will conduct population health management for patients with COPD | Other: Population-health management<br>* Population-health management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome) |  | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD-related quality- of-life | Clinical COPD Questionnaire (CCQ). The CCQ includes 10 items encompassing three domains (symptoms, functional state, and mental state). Response options range from never to almost all the time and are scored from 0-to-6. The total score is calculated by the addition of each item divided by the total number of items, producing a range of scores between 0-6. | 3 months after intervention | 
| Proportion of patients with COPD exacerbation |  | 6 months after intervention | 
| Proportion of patients with pneumonia |  | 6 months after intervention | 
| Proportion of patients with hospitalization |  | 6 months after intervention | 
| Proportion of patients with Death |  | 6 months after intervention | 
| Quality of COPD care | Proportion of evidence-based practices received | 3 months after intervention | 
| Acceptance of Recommendations | Proportion of recommendations that are accepted by PCPs | 3 months after intervention | 
| Heterogeneity of treatment effect on primary and secondary outcomes by subgroup | Compare heterogeneity of treatment effect on primary and secondary outcomes by intervention priority/risk, age, race, sex, rurality, and multimorbidity. | 6 months after intervention |