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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Research

A large cluster randomized trial of outcome-based pathways to improve home-based wound care

Authors: Merrick Zwarenstein, Salimah Shariff, Nicole Mittmann, Anita Stern, Katie N. Dainty

Published in: Trials | Issue 1/2017

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Abstract

Background

Although not always recognized as a pressing health care problem, wounds are a common, complex and costly condition. The burden of treating wounds is growing rapidly due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. The Integrated Client Care (ICC) Project was a multi-year initiative to develop and test a new, integrated model of wound care within the home care sector in Ontario, Canada to improve health outcomes for patients and decrease system costs.

Methods

Cluster randomized trial, with allocation of intervention randomized at the cluster level (14 home care centers) and analysis of outcomes based on individual-level data (patients). Primary analysis was an intention-to-treat (ITT) analysis. Two wound types, diabetic foot ulcers and pilonidal sinus, were selected as tracer conditions to assess the impact of the intervention on two different patient populations. Time to successful discharge from home care was analyzed using multivariable Cox proportional hazards regression. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented.

Results

A total of 12,063 diabetic foot ulcer patients and 1954 pilonidal sinus patient records were available for analysis. No appreciable differences were observed between patients in the control and intervention arms for either of the primary or secondary analyses in either condition group. In the diabetic foot ulcer group, 72.7% patients in the control arm and 73.6% patients in the intervention arm were discharged in the follow-up period (HR 1.05; 95% CI 0.94 to 1.17). In the pilonidal sinus group, 91.0% patients in the control arm and 89.0% patients in the intervention arm were discharged in the follow-up period (HR 0.96; 95% CI 0.82 to 1.12).

Conclusion

As implemented, the ICC intervention was not effective, most likely due to failure of implementation, and is, therefore, not ready for widespread implementation in Ontario. Significant work remains to be done to correct the implementation process so that the concept of outcome-based health care can be properly evaluated.

Trial registration

ClinicalTrials.gov, ID: NCT01573832. Registered on 12 January 2012.
Footnotes
1
Outcome pathways are the quality management tool used by the CCACs to measure whether patients were meeting expected timelines for initiation of each stage of evidence-based care and milestones towards and including wound healing.
 
2
Clinical pathways are multidisciplinary care tools based on evidence-based clinical practices (as against outcomes) for a specific group of patients with a predictable clinical course.
 
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Metadata
Title
A large cluster randomized trial of outcome-based pathways to improve home-based wound care
Authors
Merrick Zwarenstein
Salimah Shariff
Nicole Mittmann
Anita Stern
Katie N. Dainty
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2082-5

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