RCT of a Written Action Plan vs. Usual Care in Children With Acute Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the proposed large, high-intensity, randomised controlled trial is to
      evaluate the real-life effectiveness of providing a written action plan to asthmatic children
      discharged from the emergency department (ED) or hospital on the short-term adherence to
      written recommendations (including medication, attendance to asthma education and medical
      follow-up). main outcome is adherence to prescribed inhaled preventive medication measured by
      an electronic counter. Secondary outcomes include attendance to asthma education and to
      medical follow-up, serving by pharmacy of prescription of oral steroids, as well as asthma
      control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists, relapse
      to emergency room.
    

Detailed description: 
      The objective of the proposed large, high-intensity, randomised controlled trial is to
      evaluate the real-life effectiveness of providing a written action plan to asthmatic children
      discharged from the emergency department (ED) or hospital on the short-term adherence to
      written recommendations (including medication, attendance to asthma education and medical
      follow-up). Contrary to the traditional definition of a written action plan,1 i.e., a set of
      written instructions to follow in case of an exacerbation, we propose to test a new written
      action plan based on the innovative concept that emphasises the key elements associated with
      good asthma care: (1) use of preventive medication, (2) need for asthma education, (3) need
      for regular medical review, (4) environmental control and (5) instructions for use of rescue
      medication. The main outcome is adherence to prescribed inhaled preventive medication
      measured by an electronic counter. Secondary outcomes include attendance to asthma education
      and to medical follow-up, serving by pharmacy of prescription of oral steroids, as well as
      asthma control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists,
      relapse to emergency room. Because of the recommended medical follow-up where primary care
      physicians may recommend a change in the preventive treatment initiated in hospital, only
      short-term outcomes occurring within 28 days of the index visit will be considered as
      associated with the use of the written action plan. We have purposely designed this trial to
      test the additional benefit of the intervention over the usual care, recognizing the
      heterogeneity in the amount of asthma information provided within the time constraints of the
      emergency room by our 90 physicians. To provide clinically meaningful and generalisable
      information, the eligibility criteria for study entry have been limited to the bare necessity
      to confirm the diagnosis of asthma. The randomisation will be stratified on age to reflect
      the target interlocutor of the written action plan, namely the parents for the 60% children
      aged < 6 years, the child and parent pair for the 40% children aged 7 to 12 years old, and
      the adolescents for the 10% patients aged 13-17 years old. We anticipate important variations
      in the characteristics of enrolled patients reflecting the real heterogeneity of the
      emergency department attendees, namely in the severity of baseline exacerbation (55% mild,
      35% moderate, 10% severe), ownership of a written action plan (15%), prior asthma education
      (30%), use of daily preventive medicine (25%), etc, all of which may influence the adherence
      rate to the written action plan. To compensate this heterogeneity in patients'
      characteristics and provided instructions, the power of the trial to identify a clinically
      important difference in the main outcome has been set at 90% rather than the traditional 80%.
      The strength of the proposed study is clearly the assessment the real-life effectiveness of
      providing a new concept written action plan to a high-risk population to improve the main
      obstacles to good asthma control, namely adherence to preventive medication and attendance to
      asthma education and regular review.
    

Intervention name(s): Written Action Plan for Acute Asthma
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: asthma; children; written action plan; education; guided self-management; efficacy; compliance; b2-agonists; inhaled corticosteroids; oral steroids; relapse; randomised controlled trial; emergency department