Croup Clinical Trial
Official title:
A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice
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.
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 1,000 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 admission/discharge criteria. Development of these guidelines have included
the following: a)convening 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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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