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Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
Not Recruiting
Trial ID: NCT00395083
Purpose
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.
Official Title
CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
Stanford Investigator(s)
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
Intervention(s):
behavioral: COPD Self-management Education
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305