NCT05306743

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

Pragmatic Evaluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD (PREVAIL)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Observational and Pragmatic Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-09-23
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-04-01
• Last updated: 2023-10-12

Locations

3 sites across 1 country: United States