Actively Recruiting

Phase Not Applicable
All Genders
ID05718102

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

Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2026-03-25

4000

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic obstructive pulmonary disease (COPD) affects over 26 million Americans and is a leading cause of death in the United States. Many patients do not receive the best treatments, partly because primary care providers (PCPs) manage most COPD patients and face competing demands. This research compares the effectiveness of pharmacist-led population management with pulmonary specialist-led management to improve COPD care through evidence-based recommendations delivered as electronic consultations (E-consults) to PCPs. The study randomly assigns PCPs at five medical centers to one of two groups: population management by clinical pharmacists or by pulmonary specialists. Both groups review patient panels using electronic health records to identify COPD patients and provide guideline-based recommendations through E-consults with unsigned orders for PCPs to accept, modify, or decline. This approach aims to improve treatment quality and patient outcomes in COPD management. Participants include PCPs and their COPD patients, who will be monitored for outcomes such as COPD exacerbations, pneumonia, hospitalizations, or death up to six months after intervention. Researchers will also assess quality of COPD care, patient quality of life using the Clinical COPD Questionnaire, acceptance of recommendations by PCPs, and costs incurred by patients and caregivers. The study will help determine if pharmacist-led care is as effective as pulmonologist-led care in managing COPD.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary care providers and advanced practice providers practicing at participating sites
  • Patients diagnosed with or treated for COPD
  • Patients with recent hospital discharge for COPD exacerbation
  • Patients with recent outpatient COPD exacerbation
  • Patients prescribed inhaled corticosteroids without meeting criteria for use
  • Patients diagnosed with COPD who are active smokers without smoking cessation aid
  • Patients treated for COPD without spirometry evidence within 10 years or without airflow obstruction on spirometry
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Population-health Management

Duration - 180 days

Participants receive population-health management led by either pharmacists or pulmonologists to improve quality, safety, and patient experience in COPD care.

Visits as part of routine care led by pharmacists or pulmonologists

Follow-up

Duration - Up to 180 days after intervention

Participants are observed to assess outcomes related to COPD exacerbation, pneumonia, hospitalization, death, quality of life, and healthcare costs.

Assessments conducted during routine visits or remotely as applicable

Trial Site Locations

Total: 5 locations

1

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States, 55417

Actively Recruiting

2

Portland VA Medical Center

Portland, Oregon, United States, 97239

Actively Recruiting

3

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States, 29401

Actively Recruiting

4

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108

Actively Recruiting

5

Mann-Grandstaff VA Medical Center

Spokane, Washington, United States, 99205

Actively Recruiting

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Research Team

J

Jennifer A McDowell, MS

E

Emily E Gleason

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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