Elsevier

American Heart Journal

Volume 199, May 2018, Pages 75-82
American Heart Journal

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

https://doi.org/10.1016/j.ahj.2017.12.013Get rights and content

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.

Section snippets

Trial registration and ethics

The trial is registered on clinicaltrials.gov (NCT02112227) and approved by the Research Ethics Boards of participating hospitals and community agencies.

Selection of hospitals

We sent invitations for trial participation to 11 large, tertiary care cardiac centers across southern Ontario. Hospitals that agreed to implementation of the services following a Stepped Wedge design were included. Representatives of 1 hospital could not agree to a randomized sequence of implementation across sites; we excluded this hospital

Discussion

Knowledge Translation (KT) is an iterative process that includes synthesis, dissemination, exchange and application of knowledge to improve health, provide effective health services and products, and strengthen the health care system.[43] The PACT-HF model, informed by a prior comparative effectiveness meta-analysis of transitional care services,13 translates knowledge to action by implementing in real world settings those services that improved clinical outcomes in the tightly-controlled

Acknowledgements

We are indebted to Daniel Ball, Elizabeth Banting, Maria De Leon, Nancy Elford, Jeanine Harrison, Elena Holt, Gail Johnson, Colleen Lackey, Bill Liu, Roberta Napoleoni, Tracey Renton, Donna Richardson, Teresa Smith, Nazneen Solkar, Anne Stephens, and Shannon Tyrrell for their important roles in the PACT-HF trial. This work is dedicated to the memory of Aubrey Ignatius Van Spall, beloved father and friend.

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    Registration: clinicaltrials.gov (NCT02112227)

    View full text