Recruiting

Observational Study

Sponsor:

Observational and Pragmatic Research Institute

Code:

NCT05306743

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CONQUEST Quality Improvement Program

Study Details

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 pulmonary disease with or without a current diagnosis.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT05306743

Start date

Sep 23, 2022

Status verified date

Oct, 2023

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

CONQUEST Quality Improvement Program

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.

Primary outcome measure

  • 1a: COPD Exacerbations and 1b) major cardiac or respiratory events [ Time Frame: During the 2-year outcome evaluation period ]

Central Contacts and Locations

Central contacts

David Price, FRCGP

+65 3105 1489dprice@opri.sg

Locations

University of Colorado

Recruiting

Denver, Colorado, United States, 80309

Mount Sinai

Recruiting

New York, New York, United States, 10029

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

More Information

Sponsor

Observational and Pragmatic Research Institute

Last update posted

Oct 12, 2023

Last verified

Oct, 2023

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Chronic Obstructive Lung Disease
  • Chronic Obstructive Airway Disease
  • Quality Improvement Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Observational and Pragmatic Research Institute on 2023-10-12.