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

Not Applicable

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Population-health management

• Registration Number: NCT05718102
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Study Start: 2023-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist led	Population-health management	Pharmacists will conduct population health management for patients with COPD
Pulmonologist led	Population-health management	Pulmonologists will conduct population health management for patients with COPD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	90 days after intervention	Proportion of evidence-based practices received
COPD-related quality- of-life	90 days after intervention	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.
Patient-incurred costs	180 days after intervention	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.
Caregiver-incurred costs	180 days after intervention	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.
Acceptance of Recommendations	90 days after intervention	Proportion of recommendations that are accepted by PCPs
Heterogeneity of treatment effect on primary and secondary outcomes by subgroup	180 days after intervention	Compare heterogeneity of treatment effect on primary and secondary outcomes by intervention priority/risk, age, race, sex, rurality, and multimorbidity.

Trial Locations

Locations (5)

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

Ralph H. Johnson VA Medical Center; 🇺🇸 Charleston, South Carolina, United States

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

Mann-Grandstaff VA Medical Center; 🇺🇸 Spokane, Washington, United States