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

Conditions

• Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Population-health management — OTHER
  Population-health management

Study Details

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.

Key Dates

Start date

May 15, 2023

Status verified

Mar 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

4,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Pharmacist led
  Pharmacists will conduct population health management for patients with COPD
• Active Comparator: Pulmonologist led
  Pulmonologists will conduct population health management for patients with COPD

Primary Outcome Measure

Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome) [ Time Frame: 180 days after intervention ]

Central Contacts

• Jennifer A McDowell, MS
  206.277.1139
  [email protected]
• Emily E Gleason
  206.277.6739
  [email protected]

Locations (5)

Find similar trials in Minneapolis, MN

Related Studies

• Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
  PHASE3 · Recruiting · GlaxoSmithKline · Loxahatchee Groves, Florida
• Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
  PHASE3 · Recruiting · GlaxoSmithKline · Sheffield, Alabama
• Trial to Determine Effective Aspirin Dose in COPD
  PHASE3 · Recruiting · Johns Hopkins University · Baltimore, Maryland
• A Study of the Effect of a Nurse Navigator Program on High Risk Patients
  Not Yet Recruiting · Mayo Clinic · Jacksonville, Florida