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 — OTHER
    CONQUEST 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 Arm
    Intervention arm clusters will receive the CONQUEST quality improvement program.
  • Other: Delayed Intervention Arm
    The 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

Locations (3)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80309
Rodger Kessler, PhD
Mount SinaiNew YorkNew York10029
Juan Wisnivesky, MD
MetroHealthClevelandOhio44109
Yasir Tarabichi, MD

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