Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD): protocol for a pilot randomised controlled trial

Anne M Holbrook; Kristina Vidug; Lindsay Yoo; Sue Troyan; Sam Schulman; James Douketis; Lehana Thabane; Stephen Giilck; Yousery Koubaesh; Sylvia Hyland; Karim Keshavjee; Joanne Ho; Jean-Eric Tarride; Amna Ahmed; Marianne Talman; Blair Leonard; Khursheed Ahmed; Mohammad Refaei; Deborah M Siegal

doi:10.1186/s40814-022-01130-z

Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD): protocol for a pilot randomised controlled trial

Pilot Feasibility Stud. 2022 Aug 2;8(1):166. doi: 10.1186/s40814-022-01130-z.

Authors

Anne M Holbrook^{1

2

3

4

5}, Kristina Vidug⁶, Lindsay Yoo⁶, Sue Troyan⁶, Sam Schulman⁷, James Douketis^{8

9

7}, Lehana Thabane^{6

8}, Stephen Giilck^{9

10}, Yousery Koubaesh^{9

11}, Sylvia Hyland¹², Karim Keshavjee¹³, Joanne Ho^{14

15

16}, Jean-Eric Tarride^{8

17

18}, Amna Ahmed^{9

19}, Marianne Talman^{9

19}, Blair Leonard²⁰, Khursheed Ahmed⁶, Mohammad Refaei²⁰, Deborah M Siegal^{21

22}

Affiliations

¹ Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada. holbrook@mcmaster.ca.
² Clinical Pharmacology Research, Research Institute of St Joes Hamilton, Hamilton, ON, Canada. holbrook@mcmaster.ca.
³ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada. holbrook@mcmaster.ca.
⁴ Division of General Internal Medicine, Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada. holbrook@mcmaster.ca.
⁵ Department of Medicine, Hamilton Health Sciences, Hamilton, ON, Canada. holbrook@mcmaster.ca.
⁶ Clinical Pharmacology Research, Research Institute of St Joes Hamilton, Hamilton, ON, Canada.
⁷ Divsion of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, ON, Canada.
⁸ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada.
⁹ Division of General Internal Medicine, Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Medicine, Grand River Hospital, Kitchener, ON, Canada.
¹¹ Department of Medicine, Brantford General Hospital, Brantford, ON, Canada.
¹² Institute for Safe Medication Practices Canada, North York, ON, Canada.
¹³ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
¹⁴ Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
¹⁵ Research Institute for Aging, Schlegel-University of Waterloo, Waterloo, ON, Canada.
¹⁶ Division of Geriatric Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.
¹⁷ Center for Health Economic and Policy Analysis (CHEPA), McMaster University, Hamilton, ON, Canada.
¹⁸ Programs for Assessment of Technology in Health (PATH), Research Institute of St. Joe's Hamilton, Hamilton, ON, Canada.
¹⁹ Department of Medicine, Hamilton Health Sciences, Hamilton, ON, Canada.
²⁰ Department of Medicine, Niagara Health System, Regional Municipality of Niagara, Canada.
²¹ Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
²² Ottawa Hospital Research Institute, Ottawa, ON, Canada.

Abstract

Background: Oral anticoagulants (OACs) are commonly prescribed, have well-documented benefits for important clinical outcomes but have serious harms as well. Rates of OAC-related adverse events including thromboembolic and hemorrhagic events are especially high shortly after hospital discharge. Expert OAC management involving virtual care is a research priority given its potential to reach remote communities in a more feasible, timely, and less costly way than in-person care. Our objective is to test whether a focused, expert medication management intervention using a mix of in-person consultation and virtual care follow-up, is feasible and effective in preventing anticoagulation-related adverse events, for patients transitioning from hospital to home.

Methods and analysis: A randomized, parallel, multicenter design enrolling consenting adult patients or the caregivers of cognitively impaired patients about to be discharged from medical wards with a discharge prescription for an OAC. The interdisciplinary multimodal intervention is led by a clinical pharmacologist and includes a detailed discharge medication reconciliation and management plan focused on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; and early post-discharge follow-up virtual medication check-up visits at 24 h, 1 week, and 1 month. The control group will receive usual care plus encouragement to use the Thrombosis Canada website. The primary feasibility outcomes include recruitment rate, participant retention rates, trial resources management, and the secondary clinical outcomes include adverse anticoagulant safety events composite (AASE), coordination and continuity of care, medication-related problems, quality of life, and healthcare resource utilization. Follow-up is 3 months.

Discussion: This pilot RCT tests whether there is sufficient feasibility and merit in coordinating oral anticoagulant care early post-hospital discharge to warrant a full sized RCT.

Trial registration: NCT02777047.

Keywords: Anticoagulation; Hospital discharge; Medication management; Pilot trial; Transitional care.

Associated data

ClinicalTrials.gov/NCT02777047

Grants and funding

365834/CAPMC/ CIHR/Canada