A large cluster randomized trial of outcome-based pathways to improve home-based wound care
| Autor: | Salimah Z. Shariff, Anita Stern, Merrick Zwarenstein, Katie N. Dainty, Nicole Mittmann |
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| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Cost-Benefit Analysis Medicine (miscellaneous) Kaplan-Meier Estimate 01 natural sciences law.invention 010104 statistics & probability 03 medical and health sciences Wound care Pilonidal Sinus 0302 clinical medicine Randomized controlled trial Nursing Ambulatory care law Health care medicine Humans Pharmacology (medical) 030212 general & internal medicine 0101 mathematics Aged Proportional Hazards Models Ontario Wound Healing lcsh:R5-920 Intention-to-treat analysis business.industry Research Hazard ratio Health Care Costs Middle Aged medicine.disease Home Care Services Diabetic foot Diabetic Foot Intention to Treat Analysis Treatment Outcome Diabetic foot ulcer Multivariate Analysis Emergency medicine Female lcsh:Medicine (General) business Delivery of Health Care |
| Zdroj: | Trials, Vol 18, Iss 1, Pp 1-11 (2017) Trials |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-017-2082-5 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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