PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Observational and Pragmatic Research Institute
- Study ID
- NCT05306743
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CONQUEST Quality Improvement Program — OTHERCONQUEST supports primary healthcare professionals to diagnose, assess, and optimize the management of their patients with modifiable high-risk COPD, through the promotion of guideline-based care. CONQUEST will promote management according to four "Quality Standards" for the care of modifiable high-risk COPD patients. The Quality Standards can be summarized as the timely and appropriate: Identification of high-risk patient groups for assessment; Assessment of disease and quantification of future risk; Non-pharmacological and pharmacological intervention; Follow-up. CONQUEST program will promote adherence to these standards through the use of electronic medical record -based algorithms for the identification of high-risk patients and clinical decision support resources. All decisions regarding patient management are made entirely at the discretion of the clinicians and patients who together negotiate the preferred course of action during consultations.
Study Details
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.
Key Dates
- Start date
- Sep 23, 2022
- Status verified
- Oct 2023
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 126 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: CONQUEST Intervention ArmIntervention arm clusters will receive the CONQUEST quality improvement program.
- Other: Delayed Intervention ArmThe CONQUEST quality improvement program will be rolled-out to the delayed intervention practices at the end of the outcome evaluation period.
Primary Outcome Measure
1a: COPD Exacerbations and 1b) major cardiac or respiratory events [ Time Frame: During the 2-year outcome evaluation period ]
Central Contacts
- David Price, FRCGP+65 3105 1489
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80309 | Rodger Kessler, PhD |
| Mount Sinai | New York | New York | 10029 | Juan Wisnivesky, MD |
| MetroHealth | Cleveland | Ohio | 44109 | Yasir Tarabichi, MD |
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