search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONQUEST Quality Improvement Program
Sponsored by
Observational and Pragmatic Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease, Quality Improvement Program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of ColoradoRecruiting
  • Mount SinaiRecruiting
  • MetroHealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CONQUEST Intervention Arm

Delayed Intervention Arm

Arm Description

Intervention arm clusters will receive the CONQUEST quality improvement program.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Systemic corticosteroid use (SCS)
To evaluate the impact of the CONQUEST program on systemic corticosteroid (SCS) use to treat COPD exacerbations during the outcome evaluation period.

Full Information

First Posted
March 13, 2022
Last Updated
October 11, 2023
Sponsor
Observational and Pragmatic Research Institute
Collaborators
The DARTNet Institute (DI), AstraZeneca, Optimum Patient Care Global Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT05306743
Brief Title
PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Acronym
PREVAIL
Official Title
Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Observational and Pragmatic Research Institute
Collaborators
The DARTNet Institute (DI), AstraZeneca, Optimum Patient Care Global Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a frequently underdiagnosed major health problem, responsible for over 250 million cases of disease and 3 million deaths (5% of all deaths) worldwide in 2015. Despite resulting in more than $30 billion in direct healthcare costs in the USA, and causing significant morbidity and lost days of work, COPD remains a globally under-recognised condition, with an estimated 60% of cases undetected at any one time, and frequently misdiagnosed in smokers and people with asthma. Even once diagnosed, about two thirds of patients will have already experienced significant lung function decline or previous serious exacerbations, indicating that opportunities for earlier diagnosis may have been lost. The consequences of this have been summarized persuasively using data from large population-based studies of patients, demonstrating higher future risk of exacerbations, accelerated lung function decline, greater risk of cardiovascular events, higher mortality rates, and larger healthcare costs in late diagnosed patients with a symptomatic history. Several proof of principle studies have demonstrated the feasibility of case finding in primary care, however, in practice it is patchily implemented if at all, with inconsistent evidence demonstrating significant positive impact. This is partially because post-case finding, patient follow-up and management can be poor and significant subgroups of COPD patients with frequent exacerbations or high symptom scores remain undertreated or under-monitored according to quality standards. Such patients represent a high-risk "phenotype" in whom risk may be reduced with dedicated measures taken for individualized, targeted management. This may be achieved by analyzing patient electronic medical records (EMR) data as a means to identify patients with modifiable, high-risk COPD in whom there remains options to further optimize their treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations. The CONQUEST intervention (Collaboration on a Quality Improvement Initiative to Achieve Excellence in Standards of COPD Care) will address areas for optimization of the management of patients with modifiable high-risk COPD, or potential COPD, through a targeted Quality Improvement Program (QIP) in primary care practices. The intervention will implement validated algorithms (appropriately adapted for CONQUEST) to identify patients with modifiable high-risk COPD or undiagnosed patients with potential modifiable high-risk COPD, and support their management through a multicomponent package incorporating Clinical Decision Support (CDS). Parallel to this, the pragmatic cluster randomized controlled trial - "PREVAIL" (PRagmatic EVAluation of a quality Improvement program for people Living with modifiable high-risk COPD) will be conducted evaluating the effectiveness of the CONQUEST intervention compared to usual care. Primary care teams will be the cluster unit of randomization. Because of the established relationship between risk of major cardiac events and exacerbations, the effectiveness of the CONQUEST program will be evaluated in terms of COPD exacerbations and cardiovascular or respiratory events. The design of this trial presents a unique opportunity to compare major adverse cardiac or respiratory events (MACRE) outcomes in a naturally-occurring group of patients who are both frequent exacerbators and either treatment-naïve or undertreated at trial baseline, and to measure these outcomes over a period of time comparatively longer than the standard 52 weeks of many clinical trials of COPD medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease, Quality Improvement Program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONQUEST Intervention Arm
Arm Type
Experimental
Arm Description
Intervention arm clusters will receive the CONQUEST quality improvement program.
Arm Title
Delayed Intervention Arm
Arm Type
Other
Arm Description
The CONQUEST quality improvement program will be rolled-out to the delayed intervention practices at the end of the outcome evaluation period.
Intervention Type
Other
Intervention Name(s)
CONQUEST Quality Improvement Program
Intervention Description
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 Information:
Title
1a: COPD Exacerbations and 1b) major cardiac or respiratory events
Description
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).
Time Frame
During the 2-year outcome evaluation period
Secondary Outcome Measure Information:
Title
Systemic corticosteroid use (SCS)
Description
To evaluate the impact of the CONQUEST program on systemic corticosteroid (SCS) use to treat COPD exacerbations during the outcome evaluation period.
Time Frame
During the 2 year outcome evaluation period
Other Pre-specified Outcome Measures:
Title
Exploratory Objective 1: The rate of explanatory diagnoses other than COPD
Description
To evaluate the impact of the CONQUEST program on the rate of explanatory diagnoses other than COPD, diagnosed during the implementation or outcome evaluation periods.
Time Frame
During implementation and outcome evaluation period, 2.5 years
Title
Exploratory Objective 2: Lung function
Description
To evaluate the impact of the CONQUEST program on lung function.
Time Frame
During implementation and outcome evaluation period, 2.5 years
Title
Exploratory Objective 3: Health status
Description
To evaluate the impact of the CONQUEST program on COPD health status.
Time Frame
During implementation and outcome evaluation period, 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Price, FRCGP
Phone
+65 3105 1489
Email
dprice@opri.sg
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodger Kessler, PhD
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Wisnivesky, MD
Facility Name
MetroHealth
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasir Tarabichi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs