Harriette G C Van Spall1, Shun Fu Lee2, Feng Xie3, Dennis T Ko4, Lehana Thabane3, Quazi Ibrahim2, Peter R Mitoff5, Michael Heffernan6, Manish Maingi7, Michael C Tjandrawidjaja8, Mohammad I Zia9, Mohamed Panju10, Richard Perez11, Kim D Simek2, Liane Porepa12, Ian D Graham13, R Brian Haynes3, Dilys Haughton14, Stuart J Connolly15. 1. Department of Medicine, McMaster University, Hamilton, Ontario; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario; Population Health Research Institute, Hamilton, Ontario. Electronic address: harriette.vanspall@phri.ca. 2. Population Health Research Institute, Hamilton, Ontario. 3. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario. 4. Institute for Clinical Evaluative Sciences, Ontario; Department of Medicine, University of Toronto, Toronto, Ontario. 5. Department of Medicine, University of Toronto, Toronto, Ontario; Department of Medicine, St. Joseph's Health Centre, Toronto. 6. Department of Medicine, Halton Health Care Services, Oakville, Ontario. 7. Cardiac Health Program, Trillium Health Partners, Mississauga, Ontario. 8. Department of Medicine, William Osler Health System, Brampton, Ontario. 9. Department of Medicine, University of Toronto, Toronto, Ontario; Department of Medicine, Michael Garron Hospital, Toronto, Ontario. 10. Department of Medicine, McMaster University, Hamilton, Ontario. 11. Institute for Clinical Evaluative Sciences, Ontario. 12. Department of Medicine, Southlake Regional Health Centre, Newmarket, Ontario. 13. School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario. 14. Hamilton Niagara Haldimand Brant Community Care Access Centre, Hamilton, Ontario. 15. Department of Medicine, McMaster University, Hamilton, Ontario; Population Health Research Institute, Hamilton, Ontario.
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.
RCT Entities:
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.
Authors: Muhammad Shariq Usman; Harriette G C Van Spall; Stephen J Greene; Ambarish Pandey; Darren K McGuire; Ziad A Ali; Robert J Mentz; Gregg C Fonarow; John A Spertus; Stefan D Anker; Javed Butler; Stefan K James; Muhammad Shahzeb Khan Journal: Nat Rev Cardiol Date: 2022-05-17 Impact factor: 49.421
Authors: Harriette Gc Van Spall; Tauben Averbuch; Shun Fu Lee; Urun Erbas Oz; Mamas A Mamas; James Louis Januzzi; Dennis T Ko Journal: ESC Heart Fail Date: 2020-12-02
Authors: Andreas B Gevaert; Semra Tibebu; Mamas A Mamas; Neal G Ravindra; Shun Fu Lee; Tariq Ahmad; Dennis T Ko; James L Januzzi; Harriette G C Van Spall Journal: ESC Heart Fail Date: 2021-05-02