DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care

Andrew P Costa; Connie Schumacher; Aaron Jones; Darly Dash; Graham Campbell; Mats Junek; Gina Agarwal; Chaim M Bell; Veronique Boscart; Susan E Bronskill; David Feeny; Paul C Hébert; George A Heckman; John P Hirdes; Linda Lee; Robert S McKelvie; Lori Mitchell; Samir K Sinha; Joy Davis; Tammy Priddle; Joanne Rose; Roslyn Gillan; Deborah Mills; Dilys Haughton

doi:10.1136/bmjopen-2019-030301

DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care

BMJ Open. 2019 Dec 15;9(12):e030301. doi: 10.1136/bmjopen-2019-030301.

Authors

Andrew P Costa^{1

2

3}, Connie Schumacher^{4

5}, Aaron Jones⁴, Darly Dash⁴, Graham Campbell⁴, Mats Junek^{4

2}, Gina Agarwal^{4

6}, Chaim M Bell⁷, Veronique Boscart⁸, Susan E Bronskill⁹, David Feeny¹⁰, Paul C Hébert¹¹, George A Heckman¹², John P Hirdes¹², Linda Lee⁶, Robert S McKelvie¹³, Lori Mitchell¹⁴, Samir K Sinha¹⁵, Joy Davis¹⁶, Tammy Priddle¹⁷, Joanne Rose¹⁸, Roslyn Gillan¹⁹, Deborah Mills¹⁹, Dilys Haughton⁵

Affiliations

¹ Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada acosta@mcmaster.ca.
² Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
³ Schlegel Chair in Clinical Epidemiology and Aging, McMaster University, Hamilton, Ontario, Canada.
⁴ Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
⁵ Hamilton Niagara Haldimand Brant Local Health Integration Network, Hamilton, Ontario, Canada.
⁶ Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.
⁸ Schlegel Centre for Advancing Seniors Care, Conestoga College Institute of Technology and Advanced Learning, Kitchener, Ontario, Canada.
⁹ Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
¹⁰ Department of Economics, McMaster University, Hamilton, Ontario, Canada.
¹¹ Department of Medicine, Universite de Montreal, Montreal, Québec, Canada.
¹² School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.
¹³ Department of Medicine, Western University, London, Ontario, Canada.
¹⁴ Home Care, Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada.
¹⁵ Departments of Medicine, Family and Community Medicine, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Information Management, Western Health Care Corp, Corner Brook, Newfoundland, Canada.
¹⁷ Community Support, Western Health Care Corp, Corner Brook, Newfoundland, Canada.
¹⁸ Department of Health and Community Services, Government of Newfoundland and Labrador, Saint John's, Newfoundland, Canada.
¹⁹ Community Health Services, Island Health, Victoria, British Columbia, Canada.

Abstract

Introduction: Home care clients are increasingly medically complex, have limited access to effective chronic disease management and have very high emergency department (ED) visitation rates. There is a need for more appropriate and targeted supportive chronic disease management for home care clients. We aim to evaluate the effectiveness and preliminary cost effectiveness of a targeted, person-centred cardiorespiratory management model.

Methods and analysis: The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines. The trial will be conducted in partnership with three regional, public-sector, home care providers across Canada. The primary outcome of the trial is the difference in time to first unplanned ED visit (hazard rate) within 6 months. Additional secondary outcomes are to identify changes in patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness over 6 months. We will also investigate the difference in the number of unplanned ED visits, number of inpatient hospitalisations and changes in health-related quality of life. Multilevel proportional hazard and generalised linear models will be used to test the primary and secondary hypotheses. Sample size simulations indicate that enrolling 1100 home care clients across 36 clusters (home care caseloads) will yield a power of 81% given an HR of 0.75.

Ethics and dissemination: Ethics approval was obtained from the Hamilton Integrated Research Ethics Board as well as each participating site's ethics board. Results will be submitted for publication in peer-reviewed journals and for presentation at relevant conferences. Home care service partners will also be informed of the study's results. The results will be used to inform future support strategies for older adults receiving home care services.

Trial registration number: NCT03012256.

Keywords: DIVERT scale; cardio-respiratory; chronic disease management; cluster-randomised; disease management; home care.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Canada
Cost-Benefit Analysis
Emergency Service, Hospital / statistics & numerical data
Facilities and Services Utilization
Heart Failure* / therapy
Home Care Services* / economics
Hospitalization / statistics & numerical data
Humans
Multicenter Studies as Topic
Pragmatic Clinical Trials as Topic
Proportional Hazards Models
Quality of Life
Respiratory Insufficiency* / therapy
Time-to-Treatment

Associated data

ClinicalTrials.gov/NCT03012256

Grants and funding

148933/CIHR/Canada