Emergency Department (ED)-Directed Interventions to Improve Asthma Outcomes
Condition: Acute Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to determine if evidence-based guidance on follow-up care and
      self-management provided to PCPs and patients, respectively, reduces relapses within 90 days
      for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the
      primary care provider, patients' quality of life and cost-effectiveness indicators.
    

Detailed description: 
      This prospective, randomized, open label study will include asthmatics 17-55 years of age
      with no evidence of chronic obstructive pulmonary disease. Patients will be eligible if they
      visit one of four Emergency Departments (EDs) in Edmonton or Calgary and receive treatment
      for acute asthma resulting in discharge home. All patients should have a primary care
      provider (PCP: Family Physician, Internist or Nurse Practitioner) with whom to follow-up or
      one will be found for them. At discharge patients will be randomized into three groups: A:
      Usual care; PCPs will receive a faxed copy of the ED chart and patients will receive a
      discharge plan and a paper-based educational pamphlet (treatment in the ED and at discharge
      will be left to ED physicians' discretion); B: Usual care + personalized fax to the patients'
      PCP including a copy of the ED chart and a opinion-leader (OL) letter encouraging follow-up
      within two weeks and providing management suggestions; or C: Usual care + personalized fax to
      the patients' PCP including the OL letter as described above + involvement of a case manager
      who will encourage patients' to pursue follow-up, provide management review and offer brief
      education within the next week. Outcomes will be ascertained blinded to treatment allocation
      through telephone follow-up at 30 and 90 days. A sample of 366 patients (122 per group) is
      required based on the proportion with relapse at 90 days (40%) and a chi-square test of
      association and post-hoc tests (groups A vs. B, groups B vs. C). This sample will allow for
      the detection of an moderate effect size of at least 0.171, and a difference between groups A
      and B of 50% (i.e., 40% vs. 20%) and between groups B and C of 75% (i.e., 20% vs. 5%) using
      two-sided z-tests, 80% power, α=0.025. Intention to treat analyses will be conducted. Relapse
      rates by group and associated 95% confidence intervals (CI) will be calculated. Proportions
      among groups will be compared using chi-square tests and if statistically significant,
      separate proportion tests will compare pairs of groups adjusting for multiple testing. A
      multivariable logistic regression model will adjust effect estimates for potential baseline
      imbalances and site-specific differences in effectiveness.
    

Intervention name(s): Opinion Leader letter; Involvement of a care manager; Usual care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter will contain a summary of the current asthma guidelines for ambulatory care (including: asthma education, long-term recommendations, smoking cessation, and action plan) signed by a local opinion leader. A review of the patient's management within a week of the ED visit will be recommended. The patient will also receive information regarding their acute exacerbation and will be told to review the current management of their disease with their PCP.; The involvement of a care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged; Usual care provided to asthma patients when discharged from the ED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; exacerbation; emergency department; relapse