Coordination of Oral Anticoagulant Care at Hospital Discharge

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2022-06-27

Brief Summary

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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.

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Detailed Description

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Design: Randomized controlled pilot trial, two parallel groups, blinded outcome assessment.

Eligibility Criteria: Inclusion criteria include a) adult patients within a day of their hospital discharge from internal medicine services with a discharge prescription for an OAC intended to be taken for at least 4 weeks, b) discharge is to home or to a congregant setting such as retirement home where the patient manages their own medications, c) English-speaking and d) capable of providing informed consent. Ability to consent will be measured by the COACHeD Capacity to Consent test, requiring a score of 14 or more. If the patient does not pass, a close caregiver (defined as a family member in daily contact with the patient and involved in their medication supervision), will be invited to provide consent on the patient's behalf by signing a caregiver consent form.

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.

Intervention: Intervention patients will receive:

1. Interdisciplinary intervention led by a clinical pharmacologist who is a leader in evidence-based prescribing - includes a detailed discharge medication reconciliation and management plan focussed on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; three scheduled early post-discharge virtual medication check-up visits at 24 hours, 1 week, and 1 month with triage of any problems. Medication reconciliation is a process mandated by national accreditation bodies, with incomplete and variable uptake, which reviews hospital-administered medications compared to pre-admission medications. Medication management is the more complex task of assessing and revising medications in light of patient diagnoses, current symptoms and signs, risk factors, allergies and intolerances, other medications, goals, etc. In this study, all medications will be reviewd with a focus on OAC choice, dosage, indication, duration, potential drug interactions, patient risk factors for thromboembolism versus bleeding, drug insurance, adherence challenges and health literacy. A study pharmacist with additional training, will complete the detailed medication reconciliation.
2. Hand-overs to the community care team including the main patient caregiver (if applicable), family physician, medical specialist(s), and community pharmacist, using a templated consult summary including an OAC Monitoring Checklist (example consult note shown in Figure 2). The monitoring is based on: a) best evidence (updated guidelines and dedicated evidence review using the CLOT repository of CanVECTOR and McMaster's Health Information Research Unit), and decision aid content for patients and their families to assist in anticoagulant knowledge and adherence, b) best practices regarding discharge medication management, virtual care, scalable coordination of care with clear accountability, communication and teletriage where situations require medical intervention. All consult notes are reviewed in detail with the Clinical Pharmacologist.
3. 'Virtual visits' (secure video calls from within our electronic medical record (EMR) or phone visits where video is not possible) by the study pharmacist at three follow-up time points - 24 hours post-discharge to ensure the discharge prescription medications were obtained and understood, OAC Monitoring Checklist, review other medications, solicit concerns; and at 1 week and 1 month to ensure medication adherence, review the OAC Monitoring Checklist and other medications, and solicit concerns. After each follow-up visit, a summary consult note will be sent to all circle of care providers, and any clinical events or serious concerns will be addressed by the Clinical Pharmacologist or directed to patient's family physician via phone call or direct email. Each follow-up visit with intervention patients will be recorded and tracked to ensure adherence to protocols.
4. Teletriage- The patients have the study pharmacist's contact information and can phone for assistance at any time. The study pharmacist is in constant communication with a Clinical Pharmacologist investigator for guidance. An expert Thrombosis specialist will be available on call as needed.

Conditions

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Anticoagulants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Anticoagulation Coordinated Care

Intervention Type OTHER

see above

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anticoagulation Coordinated Care

see above

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No