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PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.

RECRUITINGN/ASponsored by Observational and Pragmatic Research Institute
Actively Recruiting
PhaseN/A
SponsorObservational and Pragmatic Research Institute
Started2022-09-23
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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 pulmonary disease with or without a current diagnosis.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

COPDChronic Obstructive Pulmonary Disease

Locations3 sites

Colorado

1 site
University of Colorado
Denver, Colorado, 80309
Rodger Kessler, PhD

New York

1 site
Mount Sinai
New York, New York, 10029
Juan Wisnivesky, MD

Ohio

1 site
MetroHealth
Cleveland, Ohio, 44109
Yasir Tarabichi, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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