Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238888
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2005-10-12
Brief Title:
Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Pediatric Morbidity a PRIISME Project Program to Integrate Information Service and Manage Education
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 educationPRIISME 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 Childrens 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 hisher 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 Childrens 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 physicians visits measures of appropriateness of asthma drug use refill rate of reliever drugs ratio of inhaled preventerreliever 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
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 hisher 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 Childrens 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 physicians visits measures of appropriateness of asthma drug use refill rate of reliever drugs ratio of inhaled preventerreliever 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None