Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children

NCT ID: NCT00238888

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2011-12-31

Brief Summary

The objectives of this trials are to demonstrate, in children with poorly controlled asthma, that an intervention to increase the awareness and the impact of poor asthma control among parents and physicians of affected children and adolescents can reduce the rate of asthma emergency visits in the 12 months following the initiation of the intervention.

Detailed Description

In the philosophy of the "Programs to integrate information service and manage education(PRIISME)", the proposed randomised controlled trial will examine a novel approach based on education to trigger practice changes in community physicians and pharmacists as well as behavioural changes in parents of poorly controlled asthmatic children and in adolescents. Poorly controlled asthmatic children will be identified among those who present to the emergency department of the Montreal Children's Hospital for an acute asthma exacerbation. The novel approach hinges on alerting parents, physicians, pharmacists, and, for adolescents, the patients themselves, of the actual degree of asthma control and its impact on usual activities. The instrument used, the Asthma Quiz for Kidz, is a brief 5-item questionnaire based on the Canadian Asthma Consensus statement.

The tested intervention is comprised of (1) notifying by mail the treating physician of: the index emergency department or hospital admission, the results on the Asthma Quiz for Kidz in the month preceding the index exacerbation, the orientation of the patient to his/her local Asthma Education Centre (AEC), and the treatment protocol of the Canadian Asthma Consensus statement and providing a prescription pad containing the Asthma Impact Checklist; (2) referring the parents and child or adolescent to a personalised educational session with a highly trained asthma educator approved by the AEC, at a site identified closest to home or work; giving them a refrigerator magnet of the Asthma Quiz for Kidz; trimestrial mailing the 5-item Asthma Quiz for Kidz with a simple guide to interpret the degree of control, re-enforcing the message that control can be improved, and reminding them to consult their physician; (3) providing the identified AEC educator with a standard form, to be mailed to the treating physician and the co-ordinating centre, on which to record the results on the Asthma Quiz for Kidz, the interventions and recommendations made to the parents pertaining to environment, drug use, need to consult MD for an action plan; (4) providing pharmacists with a pad of the Asthma Quiz for Kidz to administer to identified patients at each request to refill asthma drugs.

The control intervention is the current usual care with referral of all hospitalised patients to the Montreal Children's Hospital (MCH) asthma educator (current attendance rate of 30%) and referral of non-hospitalised children to the MCH Asthma Centre, at the discretion of the emergency physicians.

The primary outcome is the rate of emergency department visits in the 12 months post-randomisation. Secondary outcomes include others measures of health care resources utilisation (hospital admission, physician's visits), measures of appropriateness of asthma drug use (refill rate of reliever drugs, ratio of inhaled preventer/reliever drugs, rate of rescue systemic steroids), and quality of life measures (for the school-aged child and the caregiver).

If proven effective in reducing asthma morbidity, the current strategy may be implemented at relatively low cost, relative to the savings in health care expenditures for poorly controlled asthmatic children. This intervention could then be tested in other populations and settings.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Asthma control awareness

Multifaceted intervention to increase the patient awareness of the leve of asthma control

Group Type: EXPERIMENTAL

asthma control awareness

Intervention Type: PROCEDURE

Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit

Usual care

Usual care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: PROCEDURE

Recommendation for asthma education and/or follow-up at the physician's discretion

Interventions

asthma control awareness

Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit

Intervention Type: PROCEDURE

Usual care

Recommendation for asthma education and/or follow-up at the physician's discretion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children between 6 and 17 years of
• acute asthma requiring emergency room visit or hospital admission
• understanding of French or English

Exclusion Criteria

1. the index exacerbation is the first episode of wheezing in the previous year,

2. there is co-existence of other chronic pulmonary (such as Bronchopulmonary dysplasia (BPD), cystic fibrosis (CF)), renal or cardiac diseases;

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Francine Ducharme

Francine Ducharme

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francine M. Ducharme, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CHUS-Ste Justine Hospital

Locations

Ste-Justine Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

015117

Identifier Type: -

Identifier Source: org_study_id