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Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial - 12/05/18

Doi : 10.1016/j.ahj.2017.12.013 
Harriette G.C. Van Spall, MD, MPH a, b, c, , Shun Fu Lee, PhD c, Feng Xie, MSc, PhD b, Dennis T. Ko, MD, MSc d, e, Lehana Thabane, PhD b, Quazi Ibrahim, MSc c, Peter R. Mitoff, MD e, f, Michael Heffernan, MD, PhD g, Manish Maingi, MD h, Michael C. Tjandrawidjaja, MD i, Mohammad I. Zia, MD e, j, Mohamed Panju, MSc, MD a, Richard Perez, MSc d, Kim D. Simek, BSc c, Liane Porepa, MD k, Ian D. Graham, MA, PhD l, R. Brian Haynes, MD, MSc, PhD b, Dilys Haughton, BScN, MHSc m, Stuart J. Connolly, MSc, MD a, c
a Department of Medicine, McMaster University, Hamilton, Ontario 
b Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario 
c Population Health Research Institute, Hamilton, Ontario 
d Institute for Clinical Evaluative Sciences, Ontario 
e Department of Medicine, University of Toronto, Toronto, Ontario 
f Department of Medicine, St. Joseph’s Health Centre, Toronto 
g Department of Medicine, Halton Health Care Services, Oakville, Ontario 
h Cardiac Health Program, Trillium Health Partners, Mississauga, Ontario 
i Department of Medicine, William Osler Health System, Brampton, Ontario 
j Department of Medicine, Michael Garron Hospital, Toronto, Ontario 
k Department of Medicine, Southlake Regional Health Centre, Newmarket, Ontario 
l School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario 
m Hamilton Niagara Haldimand Brant Community Care Access Centre, Hamilton, Ontario 

Reprint requests: Harriette GC Van Spall, MD, MPH, 20 Copeland Avenue, David Braley Research Institute Bldg, Suite C3-117, Hamilton, ON L8L 0A3.20 Copeland Avenue, David Braley Research Institute Bldg, Suite C3-117HamiltonONL8L 0A3

Abstract

Introduction

Heart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model.

Methods

Adopting an integrated Knowledge Translation (iKT) approach in which decision-makers and clinicians are partners in research, we implement and test the effectiveness of PACT-HF among patients hospitalized for HF. We use a pragmatic stepped wedge cluster randomized trial design to introduce the complex health service intervention to 10 large hospitals in a randomized sequence until all hospitals initiate the intervention. The goal is for all patients hospitalized with HF to receive self-care education, multidisciplinary care, and early follow-up with their health care providers; and in addition, for high-risk patients to receive post-discharge nurse-led home visits and outpatient care in Heart Function clinics. This requires integration of care across hospitals, home care agencies, and outpatient clinics in our publicly funded health care system. While hospitals are the unit of recruitment and analysis, patients (estimated sample size of 3200) are the unit of analysis. Primary outcomes are hierarchically ordered as time to composite all-cause readmissions / emergency department (ED) visits / death at 3 months and time to composite all-cause readmissions / ED visits at 30 days. In a nested study of 8 hospitals, we measure the patient-centered outcomes of Discharge Preparedness, Care Transitions Quality, and Quality Adjusted Life Years (QALY); and the 6-month health care resource use and costs. We obtain all clinical and cost outcomes via linkages to provincial administrative databases.

Conclusions

This protocol describes the implementation and testing of a transitional care model comprising health care services informed by high-level evidence. The study adopts an iKT and pragmatic approach, uses a robust study design, links clinical trial data with outcomes held in administrative databases, and includes patient-reported outcomes. Findings will have implications on clinical practice, health care policy, and Knowledge Translation (KT) research methodology.

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Plan


 Registration: clinicaltrials.gov (NCT02112227)


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Vol 199

P. 75-82 - mai 2018 Retour au numéro
Article précédent Article précédent
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