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

ABSTRACT: 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.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.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).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.ClinicalTrials.gov, ID: NCT01573832 . Registered on 12 January 2012.

SUBMITTER: Zwarenstein M

PROVIDER: S-EPMC5576256 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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

Zwarenstein Merrick M Shariff Salimah S Mittmann Nicole N Stern Anita A Dainty Katie N KN

Trials 20170829 1

<h4>Background</h4>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 heal ...[more]

PMID: 28851413

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Project description:We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm.This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high-risk patients using a pre-post design.There were 11 offices randomized to each of the treatment and control arms; these offices treated 337 and 330 eligible patients, respectively. Among the offices in the intervention arm, the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1 %, compared with 15.7 % in the usual care arm (difference in proportions 3.4 %, 95 % CI, -2.6 to 9.5 %). The overall rates of osteoporosis medication use increased from 14.8 % prior to activation of the automated alert to 17.6 % afterward, a nonsignificant difference.The home health intervention did not result in a significant improvement in use of osteoporosis medications in high-risk patients.

Project description:BackgroundSkilled nursing facility (SNF) patients and their caregivers who transition to home experience complications and frequently return to acute care. We tested the efficacy of the Connect-Home transitional care intervention on patient and caregiver preparedness for care at home, and other patient and caregiver-reported outcomes.MethodsWe used a stepped wedge, cluster-randomized trial design to test the intervention against standard discharge planning (control). The setting was six SNFs and six home health offices in one agency. Participants were 327 dyads of patients discharged from SNF to home and their caregivers; 11.1% of dyads in the control condition and 81.2% in the intervention condition were enrolled after onset of COVID-19. Patients were 63.9% female and mean age was 76.5 years. Caregivers were 73.7% female and mean age was 59.5 years. The Connect-Home intervention includes tools, training, and technical assistance to deliver transitional care in SNFs and patients' homes. Primary outcomes measured at 7 days included patient and caregiver measures of preparedness for care at home, the Care Transitions Measure-15 (patient) and the Preparedness for Caregiving Scale (caregiver). Secondary outcomes measured at 30 and 60 days included the McGill Quality of Life Questionnaire, Life Space Assessment, Zarit Caregiver Burden Scale, Distress Thermometer, and self-reported number of patient days in the ED or hospital in 30 and 60 days following SNF discharge.ResultsThe intervention was not associated with improvement in patient or caregiver outcomes in the planned analyses. Post-hoc analyses that distinguished between pre- and post-pandemic effects suggest the intervention may be associated with increased patient preparedness for discharge and decreased number of acute care days.ConclusionsConnect-Home transitional care did not improve outcomes in the planned statistical analysis. Post-hoc findings accounting for COVID-19 impact suggest SNF transitional care has potential to increase patient preparedness and decrease return to acute care.

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

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

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