NCT05718102 Pragmatic Trial to Enhance Quality Safety, and Patient Experience in COPD
| NCT ID | NCT05718102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Institute for Biomedical and Clinical Research |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,000 participants in total. It began in 2023-05-15 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 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.
Eligibility Criteria
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: 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
Contact & Investigator
Lucas M Donovan, MD
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System
Frequently Asked Questions
Who can join the NCT05718102 clinical trial?
This trial is open to participants of all sexes, studying Pulmonary Disease, Chronic Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05718102 currently recruiting?
Yes, NCT05718102 is actively recruiting participants. Contact the research team at jennifer.mcdowell@va.gov for enrollment information.
Where is the NCT05718102 trial being conducted?
This trial is being conducted at Minneapolis, United States, Portland, United States, Charleston, United States, Seattle, United States and 1 additional location.
Who is sponsoring the NCT05718102 clinical trial?
NCT05718102 is sponsored by Seattle Institute for Biomedical and Clinical Research. The principal investigator is Lucas M Donovan, MD at VA Puget Sound Health Care System. The trial plans to enroll 4,000 participants.