Status:
RECRUITING
PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Lead Sponsor:
Observational and Pragmatic Research Institute
Collaborating Sponsors:
The DARTNet Institute (DI)
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 p...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a frequently underdiagnosed major health problem, responsible for over 250 million cases of disease and 3 million deaths (5% of all deaths) worldwide in...
Eligibility Criteria
Inclusion
- 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."
- 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.
Key Trial Info
Start Date :
September 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05306743
Start Date
September 23 2022
End Date
December 1 2026
Last Update
October 12 2023
Active Locations (3)
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1
University of Colorado
Denver, Colorado, United States, 80309
2
Mount Sinai
New York, New York, United States, 10029
3
MetroHealth
Cleveland, Ohio, United States, 44109