Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD
NCT ID: NCT05718102
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4000 participants
INTERVENTIONAL
2023-05-15
2027-01-01
Brief Summary
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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, 4) each individual outcome within the primary composite endpoint above, and 5) patient- and caregiver-incurred costs.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Pharmacist led
Pharmacists will conduct population health management for patients with COPD
Population-health management
Population-health management
Pulmonologist led
Pulmonologists will conduct population health management for patients with COPD
Population-health management
Population-health management
Interventions
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Population-health management
Population-health management
Eligibility Criteria
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Inclusion Criteria
1. Recent discharge from hospital for COPD exacerbation
2. Recent outpatient exacerbation (emergency room (ER), primary care)
3. Received prescription for an inhaled corticosteroid (ICS) but does not meet criteria for ICS use
4. Diagnosis of COPD and/or treatment and active smoker not receiving smoking cessation aide
5. Treatment for COPD without evidence of spirometry within 10 years, or no airflow obstruction on existing spirometry
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Seattle Institute for Biomedical and Clinical Research
OTHER
Responsible Party
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Principal Investigators
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Lucas M Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
David H Au, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
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Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Portland VA Medical Center
Portland, Oregon, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Mann-Grandstaff VA Medical Center
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PCORI-23668
Identifier Type: -
Identifier Source: org_study_id
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