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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Population-health management

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov
• Study Contact Backup: Name: Emily E Gleason; Phone Number: 206.277.6739; Email: emily.gleason@va.gov

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VA Health Care System
      • Principal Investigator: Anne C Melzer, MD
      • Sub-Investigator: Arianne K Baldomero, MD
      • Contact: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Portland VA Medical Center
      • Principal Investigator: Christopher G Slatore, MD
      • Contact: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Recruiting
      • Ralph H. Johnson VA Medical Center
      • Principal Investigator: Nichole T Tanner, MD
      • Sub-Investigator: Tatsiana Y Beiko, MD
      • Sub-Investigator: William C McManigle, MD
      • Contact: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Health Care System
      • Principal Investigator: Lucas M Donovan, MD, MS
      • Principal Investigator: David H Au, MD, MS
      • Contact: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov
    • Spokane, Washington, United States, 99205
      • Recruiting
      • Mann-Grandstaff VA Medical Center
      • Principal Investigator: Allison A Lambert, MD
      • Contact: Jennifer A McDowell, MS; Phone Number: 206.277.1139; Email: jennifer.mcdowell@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pharmacist led; Pharmacists will conduct population health management for patients with COPD	Other: Population-health management; Population-health management
Active Comparator: Pulmonologist led; Pulmonologists will conduct population health management for patients with COPD	Other: Population-health management; Population-health management

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD-related quality- of-life	Clinical COPD Questionnaire (CCQ). The CCQ includes 10 items encompassing three domains (symptoms, functional state, and mental state). Response options range from "never" to "almost all the time" and are scored from 0-to-6. The total score is calculated by the addition of each item divided by the total number of items, producing a range of scores between 0-6.	90 days after intervention
Proportion of patients with COPD exacerbation		180 days after intervention
Proportion of patients with pneumonia		180 days after intervention
Proportion of patients with hospitalization		180 days after intervention
Proportion of patients with Death		180 days after intervention
Quality of COPD care	Proportion of evidence-based practices received	90 days after intervention
Acceptance of Recommendations	Proportion of recommendations that are accepted by PCPs	90 days after intervention
Heterogeneity of treatment effect on primary and secondary outcomes by subgroup	Compare heterogeneity of treatment effect on primary and secondary outcomes by intervention priority/risk, age, race, sex, rurality, and multimorbidity.	180 days after intervention
Patient-incurred costs	Compare differences in incurred costs using electronic health record data and surveys to estimate costs for care related to COPD, pneumonia, and hospitalizations. These costs will include estimated costs for transportation, copays for visits and medications, and opportunity costs for time spent on care.	180 days after intervention
Caregiver-incurred costs	Compare differences in caregiver-incurred costs using electronic health record data and surveys to estimate costs incurred by caregivers for time spent accompanying patients to care related to COPD, pneumonia, and hospitalizations. These costs will include estimated costs for transportation and opportunity costs for time spent on care.	180 days after intervention

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Lucas M Donovan, MD, VA Puget Sound Health Care System; Principal Investigator: David H Au, MD, VA Puget Sound Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Population Health Management
• Other Study ID Numbers: PCORI-23668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
• IPD Sharing Time Frame: 2028
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No