Clinical trial NCT00395083: Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
Official title: CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COPD
Emphysema
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-11-02
Enrollment: 426
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization-free Survival - Time to Event
timeFrame: From randomization until date of first hospitalization for COPD, assessed up to 26 months
measure: Hazard Ratio for First COPD Hospitalization
timeFrame: 26 months
Secondary outcomes:
measure: Hazard Ratio for All-Cause Mortality
timeFrame: 26 months
measure: Time to All-Cause Death
timeFrame: From randomization until death, assessed up to 26 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Tucson
state: Arizona
city: Loma Linda
country: United States
facility: VA Medical Center, Loma Linda
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Bay Pines
country: United States
facility: VA Medical Center, Bay Pines
state: Florida
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
city: Wichita
country: United States
facility: Robert J. Dole VAMC & ROC, Wichita
state: Kansas
city: Lexington
country: United States
facility: VA Medical Center, Lexington
state: Kentucky
city: Kansas City
country: United States
facility: VA Medical Center, Kansas City MO
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque
state: New Mexico
city: Buffalo
country: United States
facility: VA Western New York Healthcare System at Buffalo
state: New York
city: New York
country: United States
facility: New York Harbor HCS
state: New York
city: Cincinnati
country: United States
facility: VA Medical Center, Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: VA Medical Center, Oklahoma City
state: Oklahoma
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
city: Dallas
country: United States
facility: VA North Texas Health Care System, Dallas
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Vincent S. Fan, MD MPH
role: STUDY_CHAIR
References:
citation: 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 comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.