Bronchitis and Emphysema Advice and Training to Reduce Hospitalization

COPD Clinical Trial

— BREATH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00395083
• Other study ID #: 560
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 2006
• Last updated: September 4, 2014
• Start date: July 2006
• Est. completion date: September 2010

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 426
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Population to be studied

The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.

Inclusion Criteria:

1. Diagnosis of COPD confirmed by all of the following:

1. FEV1/FVC < 0.70

2. FEV1 < 80%

3. Age > 40 years

4. A current or past history of cigarette smoking (> 10 pack-years)

2. COPD hospitalization in the previous year

3. Receives care at participating VA medical center

1. Enrolled in either primary care or pulmonary clinic at the VA

2. Seen at least once in the past year in either primary care or pulmonary clinic

4. No COPD exacerbations in last 4 weeks

5. English-speaking

6. Access to telephone

Exclusion Criteria:

1. Primary clinical diagnosis of asthma

2. Medical conditions affecting the ability to participate in the study such as:

1. Comorbid illness likely to limit life expectancy < 1 year

2. Decompensated heart failure

3. Dementia

4. Uncontrolled psychiatric illness

3. Participation in another clinical intervention trial in the previous 30 days

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

Intervention

Behavioral:
• COPD Self-management Education
The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico
United States	VA Medical Center, Bay Pines	Bay Pines	Florida
United States	VA Western New York Healthcare System at Buffalo	Buffalo	New York
United States	VA Medical Center, Cincinnati	Cincinnati	Ohio
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center, Kansas City MO	Kansas City	Missouri
United States	VA Medical Center, Lexington	Lexington	Kentucky
United States	VA Medical Center, Loma Linda	Loma Linda	California
United States	New York Harbor HCS	New York	New York
United States	VA Medical Center, Oklahoma City	Oklahoma City	Oklahoma
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	VA Medical Center, Providence	Providence	Rhode Island
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	VA South Texas Health Care System, San Antonio	San Antonio	Texas
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Southern Arizona VA Health Care System, Tucson	Tucson	Arizona
United States	Robert J. Dole VAMC & ROC, Wichita	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization-free Survival - Time to Event		From randomization until date of first hospitalization for COPD, assessed up to 26 months	No
Primary	Hazard Ratio for First COPD Hospitalization		26 months	No
Secondary	Hazard Ratio for All-Cause Mortality		26 months	Yes
Secondary	Time to All-Cause Death		From randomization until death, assessed up to 26 months	Yes