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

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.

Conflict of interest statement

Ethics approval and consent to participate

The study was conducted in Ontario, Canada using coded, linked, population-based administrative databases at the Institute for Clinical Evaluative Sciences (ICES). The study was reviewed and approved by the Research Ethics Board at Sunnybrook Health Sciences Center (Toronto, Canada) in February of 2014. The data used for this study is from an administrative database automatically collected by the Institute of Clinical Evaluative Sciences and, therefore, consent was not obtained from patients directly.

Consent for publication

Not applicable.

Competing interests

Dr. Merrick Zwarenstein and Dr. Katie Dainty received salary support from the peer-reviewed grant funding this research. The authors declare that they have no competing interests.

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Figures

Fig. 1

Visual depiction of the six elements in the theoretical Integrated Client Care (ICCP) model of care

Fig. 2

Patient inclusion and exclusion diagram

Fig. 3

Kaplan-Meier curve of the proportion of clients who were successfully discharged from home care over the study period among the home care referrals with a diagnosis of diabetic foot ulcer (intention-to-treat (ITT) analysis)

Fig. 4

Kaplan-Meier curve of the proportion of clients who were successfully discharged from home care over the study period among the home care referrals with a diagnosis of pilonidal sinus (intention-to-treat (ITT) analysis)