PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Recruiting · NCT05306743 · Interventional (participants receive a specific treatment) · Lead sponsor: Observational and Pragmatic Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
CONQUEST Quality Improvement Program
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
3 locations listed across 3 US states.
- University of Colorado - Denver, Colorado, United States
- Mount Sinai - New York, New York, United States
- MetroHealth - Cleveland, Ohio, United States