NCT05306743Recruiting
PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)
Source: ClinicalTrials.gov · Last updated 12 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 13 Mar 2022
- Start date
- 23 Sept 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Observational and Pragmatic Research Institute
- Diseases
- COPD
- NCT number
- NCT05306743
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 23 Sept 2022 to the primary completion date, Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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."
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MetroHealth Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.