RCT of a Written Action Plan vs. Usual Care in Children With Acute Asthma

March 25, 2014 updated by: Francine Ducharme, McGill University Health Centre/Research Institute of the McGill University Health Centre

Does the Use of a New Written Action Plan Increase Short-term Adherence to Prescribed Medication and Asthma Control in Children Treated for an Asthma Attack in the Emergency Department: A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Ste-Justine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Children will be eligible, whether they are discharged from the ED or following a hospital admission, if:

  1. aged 1 to 17 years;
  2. presenting with acute asthma as per the 2003 Canadian Consensus Statement - The ED physician will be responsible for confirming the diagnosis of asthma;
  3. requiring at least one nebulisation of salbutamol;
  4. the ED physician plans on prescribing the patient inhaled steroids and/or inhaled b2-agonists delivered by metered dose inhaler or continuing a previously prescribed inhaled steroid;
  5. the patient intends to stay in the Province of Quebec in the next 45 days;
  6. the patient (and their parents) have a good understanding of written and spoken French or English.

Exclusion Criteria:

Children will be excluded if they:

  1. currently take asthma medications (ß2-agonist and/or inhaled steroids) using a turbuhaler or diskus, because these delivery devices cannot be fitted with Doser CT, a computerized electronic dose counter for metered dose inhalers;
  2. have another chronic lung disease (other than asthma) such as cystic fibrosis or bronchopulmonary dysplasia;
  3. have known hypersensitivity to inhaled salbutamol or fluticasone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.

Secondary Outcome Measures

Outcome Measure
Proportion of children filling their prescription of oral steroids
Use of rescue B2-agonists measured by dose counter
Quality of life in children aged 7 years and older, measured by the Juniper Questionnaire
Quality of life of their parent, measured by the Juniper Questionnaire
Asthma control, measured by the Asthma Quiz for Kidz
Attendance to asthma education
Attendance to regular medical review
Return visit rate to the ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Francine M. Ducharme, MD, MSc, CHUS-Ste Justine Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 25, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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