Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD - Trial NCT05718102

Timeline & Enrollment

Primary Outcome

Quality of COPD care,COPD-related quality- of-life,Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome)

Summary

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: The goal is to determine if two forms of usual care population management
 among patients with COPD is as good as when provided by a pharmacist relative to a pulmonary
 specialist. 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. Primary outcomes will be 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) composite endpoint of COPD exacerbation, pneumonia, hospitalization, or
 death six month after intervention. Secondary outcomes will include PCP acceptance of
 recommendations, and each individual outcome within the primary composite endpoint above.

ICD-10 Classifications