Tests a quality improvement program for adults with high-risk COPD
Tests a care improvement program against usual care in adults with COPD.
Plain-language title generated from the registry record
Registry title: PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Key facts
- Where
- Cleveland, Denver, and New York, United StatesSee the 3 sites
Where in United States
- MetroHealthCleveland, United StatesTaking people
- University of ColoradoDenver, United StatesTaking people
- Mount SinaiNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Observational and Pragmatic Research Institute
- Trial code
- NCT05306743
- Record updated
- 12 October 2023
- Original description
A 3-year cluster randomized controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.Read full original descriptionShow less
Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)
A 3-year cluster randomized controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.
Inclusion: 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: 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.
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.".