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

NCT05306743 | Recruiting

• 1 other identifier: OPRI-2003
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 1a: COPD Exacerbations and 1b) major cardiac or respiratory events

  To evaluate the effectiveness of the CONQUEST program on 1a) the annual rate of moderate or severe COPD exacerbations and on 2b) the annual rates of major adverse cardiac or respiratory events (during the outcome evaluation period).

  During the 2-year outcome evaluation period

Secondary Outcomes (1)

• Systemic corticosteroid use (SCS)

  During the 2 year outcome evaluation period

Other Outcomes (3)

• Exploratory Objective 1: The rate of explanatory diagnoses other than COPD

  During implementation and outcome evaluation period, 2.5 years

• Exploratory Objective 2: Lung function

  During implementation and outcome evaluation period, 2.5 years

• Exploratory Objective 3: Health status

  During implementation and outcome evaluation period, 2.5 years

Study Arms (2)

CONQUEST Intervention Arm

EXPERIMENTAL

Intervention arm clusters will receive the CONQUEST quality improvement program.

Other: CONQUEST Quality Improvement Program

Delayed Intervention Arm

OTHER

The CONQUEST quality improvement program will be rolled-out to the delayed intervention practices at the end of the outcome evaluation period.

Other: CONQUEST Quality Improvement Program

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.

CONQUEST Intervention Arm; Delayed Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Observational and Pragmatic Research Institute: lead
• The DARTNet Institute (DI): collaborator
• AstraZeneca: collaborator
• Optimum Patient Care Global Limited: collaborator

Study Sites (3)

University of Colorado

Denver, Colorado, 80309, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (1)

• Hickman K, Tarabichi Y, Dickens AP, Pullen R, Kerr M, Couper A, Evans A, Gatenby J, Alves L, Ariti C, Bafadhel M, Carter V, Chalmers J, Chen R, Devereux G, Drummond MB, Gibson JM, Halpin DMG, Han M, Hanania NA, Hurst JR, Kaplan A, Kostikas K, Make B, Mapel D, Marshall J, Martinez F, Meldrum C, van Melle M, Miravitlles M, Morris T, Mullerova H, Murray R, Muro S, Nordon C, Ohar J, Pace W, Pollack M, Quint JK, Sharma A, Singh D, Singh M, Trudo F, Williams D, Wilkinson T, Winders T, Price D. Pragmatic Evaluation of an Improvement Program for People Living With Modifiable High-Risk COPD Versus Usual Care: Protocols for the Cluster Randomized PREVAIL Trial. Chronic Obstr Pulm Dis. 2025 May 27;12(3):223-239. doi: 10.15326/jcopdf.2024.0564.

  PMID: 40300198 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Price, FRCGP

CONTACT

+65 3105 1489; dprice@opri.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 126 primary care teams (PCT) will be enrolled in the trial; 63 PCTs will be randomized to the intervention arm and receive the CONQUEST QIP, and 63 to the control arm where they will receive care as usual.

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: April 1, 2022
• Study Start: September 23, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

US (3)