NCT05718102

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
May 2023Jan 2027

First Submitted

Initial submission to the registry

January 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

January 25, 2023

Last Update Submit

March 20, 2026

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with COPD exacerbation, pneumonia, hospitalization, or Death (composite outcome)

    180 days after intervention

Secondary Outcomes (10)

  • COPD-related quality- of-life

    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

  • +5 more secondary outcomes

Study Arms (2)

Pharmacist led

ACTIVE COMPARATOR

Pharmacists will conduct population health management for patients with COPD

Other: Population-health management

Pulmonologist led

ACTIVE COMPARATOR

Pulmonologists will conduct population health management for patients with COPD

Other: Population-health management

Interventions

Population-health managementOTHER

Population-health management

Pharmacist ledPulmonologist led

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Recent discharge from hospital for COPD exacerbation
  • Recent outpatient exacerbation (emergency room (ER), primary care)
  • Received prescription for an inhaled corticosteroid (ICS) but does not meet criteria for ICS use
  • Diagnosis of COPD and/or treatment and active smoker not receiving smoking cessation aide
  • Treatment for COPD without evidence of spirometry within 10 years, or no airflow obstruction on existing spirometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

Mann-Grandstaff VA Medical Center

Spokane, Washington, 99205, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Population Health Management

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Lucas M Donovan, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

  • David H Au, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer A McDowell, MS

CONTACT

206.277.1139jennifer.mcdowell@va.gov

Emily E Gleason

CONTACT

206.277.6739emily.gleason@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 8, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2028

Locations

US(5)