Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02777047 |
| Other study ID # |
Anticoag Safety |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 16, 2020 |
| Est. completion date |
June 27, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
St. Joseph's Healthcare Hamilton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
