Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147849
Status:
TERMINATED
Last Update Posted:
2005-11-29
First Post:
2005-09-02
Brief Title:
A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice Guidelines for Children With Croup
Sponsor:
Canadian Institutes of Health Research CIHR
Organization:
University of Calgary
Study Overview
Official Title:
A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice
Status:
TERMINATED
Status Verified Date:
2005-09
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 purpose of this study is to identify from a societal perspective the costs and associated benefits of three strategies for disseminating and implementing a practice guideline that addresses the management of croup
Detailed Description:
Overall Aim The overall aim of this study is to identify - from a societal perspective - the costs and associated benefits of three strategies for implementing a practice guideline that addresses the management of croup
Intervention Strategies The intervention strategies to be compared will be mailing of printed educational materials the Standard intervention mailing plus a combination of interactive educational meetings educational outreach visits and reminders a Saturn intervention and a combination of mailing interactive sessions outreach visits reminders plus identification of local opinion leaders and establishment of local consensus processes a Cadillac intervention
Primary Objective To determine which of the three intervention strategies are most effective at lowering the rate of hospital days per 1000 disease episodes The null hypothesis is that none of the intervention strategies reduce hospital utilization rates from baseline The alternate hypothesis is that the intervention strategies will have a graded degree of effect on hospitalization rates with the Standard intervention having minimal to no effect the Saturn intervention having moderate but significant effect and the Cadillac intervention having the greatest effect
Secondary Objective To determine which of the three dissemination strategies are most effective at increasing the use of therapies of known benefit
Economic Analysis To determine which of the three intervention strategies will most effectively reduce total societal costs including all health care costs costs borne by the family and costs stemming from the strategies for disseminating guidelines
Other Objectives To determine which dissemination strategy will most effectively maintain or improve clinical outcomes and maintain or reduce the family psychosocial burden Clinical outcomes assessed will include both uncommon severe events such as endotracheal intubation respiratory arrest and death as well as average duration of clinical symptoms The assessment of family psychosocial burden will include the number of hours of sleep missed by the child and the stress experienced by the primary caregiver most commonly the mother
Study Plan The study objectives will be achieved through the following
1 We are completing a baseline survey which a documents Alberta-wide utilization rates for health care services b documents severe adverse outcomes Alberta-wide c rank orders Alberta hospitals based on rates of hospitalization d documents therapeutic practices in 24 selected Alberta hospitals and e documents through the use of a prospectively administered survey the psychosocial burden of the disease on families in the same 24 Alberta hospitals
2 We are developing clinical guidelines that address indications for drug therapy and hospital admissiondischarge criteria Development of these guidelines have included the following aconvening an expert panel b critically reviewing the published literature c drafting guidelines which meet standard criteria for developing guidelines d obtaining approval of the guidelines by the Canadian Pediatric Society Canadian Association of Emergency Physicians and the Alberta Medical Association and e publishing the guidelines in journals such as the CMAJ
3 We have identified 24 Alberta hospitals and will randomize them to one of the three dissemination strategies outlined above
4 We will complete a follow-up survey which a documents Alberta-wide severe adverse outcomes and utilization rates b documents practice patterns in the same 24 Alberta hospitals surveyed at baseline and c documents the psychosocial burden of the disease on families in these same hospitals
5 We will complete a statistical analysis comparing the three randomized groups of hospitals in terms of the change in health care utilization change in physician use of effective therapies and change in the psychosocial burden of the disease on families
6 We will complete an economic analysis that compares the change in benefits derived from the three types of dissemination strategies with the relative costs change in health care costs relative costs associated with the three types of dissemination strategies and change in costs borne by the family such as lost wages
Intervention Strategies The intervention strategies to be compared will be mailing of printed educational materials the Standard intervention mailing plus a combination of interactive educational meetings educational outreach visits and reminders a Saturn intervention and a combination of mailing interactive sessions outreach visits reminders plus identification of local opinion leaders and establishment of local consensus processes a Cadillac intervention
Primary Objective To determine which of the three intervention strategies are most effective at lowering the rate of hospital days per 1000 disease episodes The null hypothesis is that none of the intervention strategies reduce hospital utilization rates from baseline The alternate hypothesis is that the intervention strategies will have a graded degree of effect on hospitalization rates with the Standard intervention having minimal to no effect the Saturn intervention having moderate but significant effect and the Cadillac intervention having the greatest effect
Secondary Objective To determine which of the three dissemination strategies are most effective at increasing the use of therapies of known benefit
Economic Analysis To determine which of the three intervention strategies will most effectively reduce total societal costs including all health care costs costs borne by the family and costs stemming from the strategies for disseminating guidelines
Other Objectives To determine which dissemination strategy will most effectively maintain or improve clinical outcomes and maintain or reduce the family psychosocial burden Clinical outcomes assessed will include both uncommon severe events such as endotracheal intubation respiratory arrest and death as well as average duration of clinical symptoms The assessment of family psychosocial burden will include the number of hours of sleep missed by the child and the stress experienced by the primary caregiver most commonly the mother
Study Plan The study objectives will be achieved through the following
1 We are completing a baseline survey which a documents Alberta-wide utilization rates for health care services b documents severe adverse outcomes Alberta-wide c rank orders Alberta hospitals based on rates of hospitalization d documents therapeutic practices in 24 selected Alberta hospitals and e documents through the use of a prospectively administered survey the psychosocial burden of the disease on families in the same 24 Alberta hospitals
2 We are developing clinical guidelines that address indications for drug therapy and hospital admissiondischarge criteria Development of these guidelines have included the following aconvening an expert panel b critically reviewing the published literature c drafting guidelines which meet standard criteria for developing guidelines d obtaining approval of the guidelines by the Canadian Pediatric Society Canadian Association of Emergency Physicians and the Alberta Medical Association and e publishing the guidelines in journals such as the CMAJ
3 We have identified 24 Alberta hospitals and will randomize them to one of the three dissemination strategies outlined above
4 We will complete a follow-up survey which a documents Alberta-wide severe adverse outcomes and utilization rates b documents practice patterns in the same 24 Alberta hospitals surveyed at baseline and c documents the psychosocial burden of the disease on families in these same hospitals
5 We will complete a statistical analysis comparing the three randomized groups of hospitals in terms of the change in health care utilization change in physician use of effective therapies and change in the psychosocial burden of the disease on families
6 We will complete an economic analysis that compares the change in benefits derived from the three types of dissemination strategies with the relative costs change in health care costs relative costs associated with the three types of dissemination strategies and change in costs borne by the family such as lost wages
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U Calgary Acct No 73-1051 | None | None | None |
| CIHR App No 110642 | None | None | None |