Bronchitis and Emphysema Advice and Training to Reduce Hospitalization — BREATH  

COPD Clinical Trial

Official title: CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)

Status Terminated

Clinical Trial Summary

EXECUTIVE SUMMARY:

Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.

Hypotheses:

Primary Hypothesis:

Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.

Primary Objective:

In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.

Secondary Hypotheses:

Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.

Secondary Objectives:

To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:

A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures

1. Mortality

2. Health-related quality of life measured by generic and COPD-specific measures

3. Patient satisfaction

4. Medication adherence

5. Disease knowledge, skill acquisition and self-efficacy

In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.

The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.

Clinical Trial Description

EXECUTIVE SUMMARY:

Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.

Hypotheses:

Primary Hypothesis:

Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.

Primary Objective:

In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.

Secondary Hypotheses:

Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.

Secondary Objectives:

To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:

A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures

1. Mortality

2. Health-related quality of life measured by generic and COPD-specific measures

3. Patient satisfaction

4. Medication adherence

5. Disease knowledge, skill acquisition and self-efficacy

In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.

The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.

Exacerbations among patients with COPD result in costly emergency room visits and hospitalizations. The overall direct and indirect medical costs of COPD for the United States in 2000 were estimated to be in excess of $30 billion. In the VA health care system, there were 16,073 discharges for COPD in fiscal year 2003 at an average cost of $9,400 (2005 dollars). Disease management programs for COPD may improve patient self-care, improving symptoms and resulting in decreased exacerbations. However, implementing the types of published programs that use self-management education and case-management require additional resources for the VA. The COPD disease management program described in this proposal was developed by extensive modification of existing programs using the strongest theory-based and evidence-based elements, and takes advantage of existing VA systems. By targeting patients at high risk for exacerbations, this study focuses on the population in which the needs and potential impact are the greatest.

The intervention is designed to enable patients with COPD to manage their disease more effectively, by monitoring their symptoms and initiating appropriate action when their symptoms worsen. The elements of the program are developed using self-efficacy theory, a recognized and powerful predictor of health-related behavior change. The goal of the intervention is an informed and activated patient working with an informed, skilled case manager to improve self-management of COPD and ultimately clinical outcomes. Case-management programs are used to improve outcomes and to reduce health care utilization among patients with other chronic diseases such as diabetes, congestive heart failure and asthma, suggesting that this approach may be successful in COPD.

A study conducted in Canada by Dr. Bourbeau, a co-investigator for this proposal, suggests that an intensive home-based self-management education program and case-management reduce the risk of COPD hospitalizations by 35% over 1-year, and reduced average hospital days by 42%. Cost-savings resulting from decreased hospitalizations offset the cost of the intervention, and the intervention was potentially cost-saving. Relying on home visits, the intervention is not practical or affordable in the VA, and therefore this study evaluates whether a novel case-management intervention for COPD developed specifically for the VA will reduce hospitalizations without increasing overall health-care costs.

Because the majority of health care costs for patients with COPD are due to hospitalizations for exacerbations, COPD admissions are the primary outcome and the principal self-management goal. Assessing the cost-effectiveness of this intervention is a critical component of the proposed study, and will provide data for evidence-based decisions by VA physicians and managers regarding the management of COPD. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchitis
• COPD
• Emphysema
• Pulmonary Emphysema

• NCT number: NCT00395083
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Terminated
• Phase: Phase 2
• Start date: July 2006
• Completion date: September 2010