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

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, 4) each individual outcome within the primary composite endpoint above, and 5) patient- and caregiver-incurred costs.

NCT Number	NCT05718102
Lead Sponsor	Seattle Institute for Biomedical and Clinical Research Collaborators: Patient-Centered Outcomes Research Institute
Conditions	Pulmonary Disease, Chronic Obstructive
Enrollment	4,000 participants
Start Date	2023-05-15
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-09