Coordination of Oral Anticoagulant Care at Hospital Discharge

NCT02777047 | Completed DMC

• 1 other identifier: Anticoag Safety
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Oral anticoagulants (OACs - warfarin, dabigatran, rivaroxaban, apixaban and edoxaban) are the very top cause of serious drug-related harm. More than 7 million prescriptions are dispensed annually for oral anticoagulants (OAC) in Canada, with more than 340,000 elderly recipients in the Ontario Drug Benefit Program alone. Because of their very high and chronic utilization, their large benefit in lowering important clinical events (stroke, clots, death) and their high potential for major harm (primarily bleeds, which can be fatal), OACs are the highest priority for improving medication safe and effective use. The early period after hospital discharge is clearly high risk, with three times the usual rate of major bleeds compared with later. Patients and families frequently note confusion about their medications after leaving the hospital due to errors or lack of detailed communication to their health care team at the time of discharge. The confusion, errors, and lack of communication are highly associated with lack of adherence to medications and resulting worse health outcomes. The combination of waste of medication and bad outcomes that result from medication errors, are estimated to cost our health care system several billion dollars annually. Since our leading economists are declaring health care to be unsustainable in its current delivery forms, it is time to find and evaluate more cost-effective ways to improve anticoagulation safety. The investigators will do this by structuring discharge medication assessment, with more expert management, formal written and verbal handovers to the patients, their family and their hospital and community doctors, pharmacists and home care; follow-up by virtual visits after discharge, and coordinate advice and communication to extend access to and reduce the cost of expert guidance. The investigators expect that this intervention will decrease anticoagulant-related adverse events and improve ratings of the coordination of care. If this occurs, the investigators will develop a business plan for regions, provinces and territories to scale up the intervention to a national level.

Conditions

Anticoagulants

Keywords

Thromboembolism; Medication Safety; Hospital-community collaboration; Pilot RCT; Telehealth

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Feasibility assessments are used to determine whether a research study is likely to be delivered successfully, taking into account the practical aspects of managing the project such as recruitment rate

  1 year

• Participant retention rate

  Feasibility assessments are used to determine whether a research study is likely to be delivered successfully, taking into account the practical aspects of managing the project such as participant retention rate

  3 months

• Estimated resources required per patient to complete the main trial

  Feasibility assessments are used to determine whether a research study is likely to be delivered successfully, taking into account the practical aspects of managing the project such as resources required per patient to complete participation in the trial.

  3 months

Secondary Outcomes (7)

• Adverse Anticoagulant Safety Events composite (AASE)

  3 months

• Coordination and Continuity of Care Questionnaire

  3 months

• Patient Quality of Life

  3 months

• Patient Knowledge of OAC Management

  3 months

• Satisfaction with Care

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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 hours, 1 week, and 1 month.

Other: Anticoagulation Coordinated Care

Control

NO INTERVENTION

Patients allocated to the control group will receive usual care, plus the URL to Thrombosis Canada website. Usual care in the participating sites includes OAC management by family doctors except for new thromboembolic events which will be followed short term by thromboembolism or hematology specialists, complicated atrial fibrillation which will have cardiology involved temporarily, and a small proportion of warfarin management which is provided in an anticoagulation clinic. This choice of control group is the most relevant for generalizability to both academic and community practices.

Interventions

Anticoagulation Coordinated Care OTHER

see above

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be excluded if they are less than 18 years of age, have an expected lifespan of less than 3 months, will be discharged to long term care or other institution where medications are controlled by staff, or decline informed consent.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Hamilton Academic Health Sciences Organization: collaborator
• Institute for Safe Medication Practices Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Hamilton Health Sciences Corporation: collaborator
• Brant Community Healthcare System: collaborator
• Grand River Hospital: collaborator
• Niagara Health System: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (3)

• Holbrook A, Troyan S, Telford V, Koubaesh Y, Vidug K, Yoo L, Deng J, Lohit S, Giilck S, Ahmed A, Talman M, Leonard B, Refaei M, Tarride JE, Schulman S, Douketis J, Thabane L, Hyland S, Ho JM, Siegal D. Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial. BMJ Open. 2024 May 1;14(5):e079353. doi: 10.1136/bmjopen-2023-079353.

  PMID: 38692712 DERIVED

• Holbrook AM, Vidug K, Yoo L, Troyan S, Schulman S, Douketis J, Thabane L, Giilck S, Koubaesh Y, Hyland S, Keshavjee K, Ho J, Tarride JE, Ahmed A, Talman M, Leonard B, Ahmed K, Refaei M, Siegal DM. 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.

  PMID: 35918731 DERIVED

• Benipal H, Holbrook A, Paterson JM, Douketis J, Foster G, Thabane L. Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol. BMJ Open. 2020 Sep 22;10(9):e036537. doi: 10.1136/bmjopen-2019-036537.

  PMID: 32963065 DERIVED

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne Holbrook, MD,PharmD,MSc

  Director, Clinical Pharmacology & Toxicology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Pharmacology and Toxicology

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 19, 2016
• Study Start: December 16, 2020
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)