CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 426
- 试验地点
- 22
- 主要终点
- Hospitalization-free Survival - Time to Event
研究概览
简要总结
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
- Mortality
- Health-related quality of life measured by generic and COPD-specific measures
- Patient satisfaction
- Medication adherence
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 FY
- •Inclusion Criteria:
- •Diagnosis of COPD confirmed by all of the following:
- •FEV1/FVC < 0.70
- •FEV1 < 80%
- •Age > 40 years
- •A current or past history of cigarette smoking (> 10 pack-years)
- •COPD hospitalization in the previous year
- •Receives care at participating VA medical center
- •Enrolled in either primary care or pulmonary clinic at the VA
- •Seen at least once in the past year in either primary care or pulmonary clinic
- •No COPD exacerbations in last 4 weeks
- •English-speaking
- •Access to telephone
排除标准
- •Primary clinical diagnosis of asthma
- •Medical conditions affecting the ability to participate in the study such as:
- •Comorbid illness likely to limit life expectancy < 1 year
- •Decompensated heart failure
- •Uncontrolled psychiatric illness
- •Participation in another clinical intervention trial in the previous 30 days
研究组 & 干预措施
Group 1
Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
Group 2
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.
干预措施: COPD Self-management Education (Behavioral)
结局指标
主要结局
Hospitalization-free Survival - Time to Event
时间窗: From randomization until date of first hospitalization for COPD, assessed up to 26 months
Hazard Ratio for First COPD Hospitalization
时间窗: 26 months
次要结局
- Hazard Ratio for All-Cause Mortality(26 months)
- Time to All-Cause Death(From randomization until death, assessed up to 26 months)