Evaluating a Quality Improvement Program for High-risk COPD Patients

Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)

This study is testing a new support program for doctors to see if it helps high-risk COPD patients get better care compared to regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Observational and Pragmatic Research Institute (Academic / other)
• Locations: 3 sites (Denver, Colorado and 2 other locations)
• Trial ID: NCT05306743 on ClinicalTrials.gov

What this trial studies

This study is a 3-year cluster randomized controlled trial that assesses the effectiveness of a quality improvement and clinical decision support program compared to usual care for patients with modifiable high-risk chronic obstructive pulmonary disease (COPD). It aims to address the underdiagnosis and mismanagement of COPD by implementing a structured approach to patient care in primary care teams. The trial will involve multiple primary care teams that will either receive the intervention or continue with standard care, allowing for a comparison of outcomes related to COPD management.

Who should consider this trial

Good fit: Ideal candidates for this study are primary care teams that manage patients with modifiable high-risk COPD.

Not a fit: Patients who are not part of a primary care team or those with stable, well-managed COPD may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could lead to improved diagnosis and management of COPD, resulting in better patient outcomes and reduced healthcare costs.

How similar studies have performed: Previous studies have shown that quality improvement initiatives in primary care can be effective, but this specific approach is novel in its focus on high-risk COPD patients.

Eligibility criteria

As a cluster randomized controlled trial, participants in PREVAIL are the Primary Care Teams. The PREVAIL CRT adopts the definition of PCT from the Agency for Healthcare Research and Quality, "a group of primary care practice personnel who identify as members of a team and who work together to provide care for a panel of patients."

Inclusion Criteria:

* Primary Care Teams (PCTs) must be able to function as a single randomization unit with low risk of contamination between participants and physicians due to the absence of blinding in the intervention (see section 8.8 for details on blinding).
* PCT must have a sufficient number of patients meeting modifiable high-risk patient criteria (see section 8.1 on sample size estimates).
* PCT must express willingness to be randomized to either receive the CONQUEST program initially, or usual care until program roll-out to the delayed intervention arm.

Exclusion Criteria:

* PCTs that are in the process of, or planning to change EHR software provider or practice ownership within the trial outcome evaluation period
* PCTs engaged in active research studies or COPD related Quality Improvement Programs which might impact the ability to implement CONQUEST program.

Where this trial is running

Denver, Colorado and 2 other locations

• University of Colorado — Denver, Colorado, United States (Recruiting)
• Mount Sinai — New York, New York, United States (Recruiting)
• MetroHealth — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: David Price, FRCGP

Conditions Chronic Obstructive Pulmonary Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Airway Disease; Quality Improvement Program