Clinical trial NCT05306743: PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
Official title: Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Chronic Obstructive Lung Disease
Chronic Obstructive Airway Disease
Quality Improvement Program
Lead sponsor: Observational and Pragmatic Research Institute
Sponsor class: OTHER
Collaborators: name: The DARTNet Institute (DI)
name: AstraZeneca
name: Optimum Patient Care Global Limited
First posted: 2022-04-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: 1a: COPD Exacerbations and 1b) major cardiac or respiratory events
timeFrame: During the 2-year outcome evaluation period
Secondary outcomes:
measure: Systemic corticosteroid use (SCS)
timeFrame: During the 2 year outcome evaluation period
Other outcomes:
measure: Exploratory Objective 1: The rate of explanatory diagnoses other than COPD
timeFrame: During implementation and outcome evaluation period, 2.5 years
measure: Exploratory Objective 2: Lung function
timeFrame: During implementation and outcome evaluation period, 2.5 years
measure: Exploratory Objective 3: Health status
timeFrame: During implementation and outcome evaluation period, 2.5 years
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
Study officials:
References: