A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice Guidelines for Children With Croup

Croup Clinical Trial

Official title:

A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00147849
• Other study ID #: MCT-63141
• Secondary ID: CIHR App No. 110
• Status: Terminated
• Phase: N/A
• First received: September 2, 2005
• Last updated: November 28, 2005
• Start date: September 2000
• Est. completion date: March 2006

Study information

• Verified date: September 2005
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Alberta hospitals were rank ordered based on the number of disease episodes and rates of hospitalization for a six-year period. We then approached in this order each of the hospital administrators and clinical staff for permission to include their hospital in our study until a total of 24 hospitals consented

Exclusion Criteria:

• Refusal by hospital staff to participate in this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Croup

Intervention

Behavioral:
• mailing of printed educational materials

• a combination of interactive educational meetings, educational outreach visits, and reminders

• identification of local opinion leaders and establishment of local consensus processes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospital days per 1,000 disease episodes
Secondary	Proportion of patients treated in the ED and hospital with a corticosteroid.
Secondary	Proportion of patients evaluated in ED for at least three hours after treatment with corticosteroids before the decision to admit to hospital is made.
Secondary	Time to treatment with corticosteroids in both ED and hospital patients.
Secondary	An economic analysis conducted from a societal perspective with costs classified as either payer (costs born by the province) or non-payer (costs born by individuals or the families of children with croup).