Examine the Impact of Early Education on COPD Management
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by
      smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations
      result in frequent, prolonged hospitalizations. While originally considered a disease
      specific to the lung, data has shown that COPD is associated with substantial cardiovascular
      (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in
      marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with
      stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;
      however, it may be due to chronic inflammation which is exacerbated with a flare-up of the
      disease, and/or chronic inactivity which is similarly worsened with bed-rest during a
      hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies
      examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.
      Disease management programs, such as pulmonary rehabilitation and patient self-management
      education, are part of guideline therapy for COPD; however, these are not regularly
      implemented following a hospitalization, and how these interventions affect patient outcomes,
      behavior, physical activity, inflammation and CV risk have not been well studied. The
      proposed long-term project will examine how early referral to chronic disease management
      programs after hospital discharge, affect patient outcomes. This study will provide
      invaluable information about outpatient management for a disease which has a tremendous
      impact on healthcare.
    

Detailed description: 
      Purpose: To examine the impact of early pulmonary education (PE) following hospital discharge
      on QoL, pulmonary/CV outcomes and AECOPD hospitalizations.

      Rationale: Studies have shown that education improves self-efficacy and QoL in COPD. Whether
      these improvements translate to increased exercise tolerance, physical activity, reduced CV
      risk and hospitalizations in patients recently discharged from hospital requires examination.

      Hypothesis: Patients who receive early education will have improved QoL, pulmonary/CV
      outcomes, and less COPD hospitalizations in the 6 months following hospital discharge.
      Education will improve self efficacy, physical activity and QoL while reducing CV risk as
      compared to usual care.

      Study Design & Subject Recruitment: In Calgary, patients discharged following an AECOPD
      hospitalization are referred to the Calgary COPD and Asthma Program (CCAP) where they are
      seen by a Certified Respiratory Educator 1-2 times within the month following discharge. For
      this study, patients will be recruited from the CCAP program and randomized into receiving
      usual care; general education sessions over the month following discharge, or the
      experimental arm; focused education following discharge from hospital. Patients found to have
      an acute cardiac injury, mobility issues or residence outside the greater Calgary area will
      be excluded. All education visits will be 1hr in length, and occur at a local outpatient
      clinic. The education will focus on patient self-management and will use Living Well with
      COPD supporting literature (www.livingwellwithcopd.com) designed to improve patient
      self-management and physical activity. All patients will be followed up 6 months after
      discharge and will be interviewed to assess disease status, management review and if there
      has been a history of recurrence or relapse of the AECOPD. Hospital admissions and length of
      stay will be obtained through electronic medical records as described above. Patient
      assessments will include: quality of life, 6min walk, dyspnea, self-efficacy, physical
      activity, pulse wave velocity (PWV), vascular function and systemic inflammation (TNF, MMP-2,
      IL-6 and CRP). All data will be collected before, immediately and 6 months after education.
      The control group will have the same data collected at the same scheduled time. See above for
      descriptions of methods.

      Data Handling: Data will be entered onto a secure anonymized database.

      Data Analysis: The influence of education on QoL, 6min walk, dyspnea, self-efficacy, physical
      activity, pulse wave velocity, vascular function and systemic inflammation will be evaluated
      using a multivariate mixed-model multivariate analysis of variance (MANOVA) with treatment
      (education vs. usual care) being a fixed between-group variable and time (pre, immediate
      post, 6months post) as a repeated variable.

      Sample size: Based on previous work, a total sample size of 140 (70 in each group) will be
      sufficient to detect a clinically significant difference in QoL and a significant difference
      in hospital readmission rates. Based on outhe investigators r recent work, this sample could
      detect a 10% difference in PWV and physical activity.
    

Intervention name(s): Pulmonary Education (PE); Usual Care
Intervention type(s): Other; Other
Intervention description(s): Patients enrolled in PE will undergo focused education sessions following discharge from hospital.; Patients enrolled in usual care will receive general education sessions following discharge from hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute Exacerbation of COPD; COPD; Emphysema; Chronic Bronchitis