Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
Condition: COPD; Emphysema
MeSH terms: Bronchitis; Pulmonary Emphysema; Emphysema
Intervention: COPD Self-management Education
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

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