Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention

McGill University

Status: Completed

Conditions: Adverse Drug Event

Treatments: Other: Deprescribing opportunities

Study type: Interventional

Funder types: Other

Identifiers

NCT03272607

CIHR Application No. 365795 (Other Grant/Funding Number)

MedSafer

Details and patient eligibility

About

Reducing medications and associated side effects in older adults: an electronic hospital-based intervention

Full description

Polypharmacy, or the concomitant use of 5 drugs or more, is a serious health concern and affects more than half of Canadians aged 65 years and older. It is the number one identifiable risk factor for adverse drug events (ADEs), which are responsible for 27,000 hospital admissions annually in Canada and up to 20% of return visits to the hospital within 30 days of discharge. Many ADEs are preventable or ameliorable through interventions to reduce inappropriate prescribing.

MedSafer, the intervention software, applies an electronic set of criteria, previously designed and piloted on one thousand (1000) hospitalized patients by a group of Quebec and Ontario internists, geriatricians, palliative care doctors and pharmacists, to identify potentially inappropriate medications (PIMs) in the hospitalized elderly and generate instructions for the patient and physician for safe discontinuation. The current study seeks to partially automate the deprescribing process and to demonstrate the efficacy of this type of intervention on adverse drug events at 30-days post hospital discharge.

At the time of hospitalization, the patient's medications, co-morbidities, and a measure of frailty will be entered into the MedSafer software which will output an individualized and prioritized deprescription plan for the most responsible physician's consideration. Any subsequent medication changes will be transmitted to relevant community physicians. The study will evaluate the impact of stopping PIMs on the occurrence of ADEs within 30 days of discharge, as compared to usual care.

This study will take place on the clinical teaching units (CTUs) at 11 hospitals from seven university hospital centres across Canada. Based on historical data, the investigators estimate a combined 5200 eligible patients per year with nearly 50% taking ten or more medications. Many will have multiple medical co-morbidities such as diabetes, heart disease, and renal insufficiency. A large portion will meet criteria for geriatric syndromes such as frailty and will be at high risk for the development of delirium, falls and functional decline. This population is ideal for a generalizable deprescribing study.

All patients aged 65 or older who meet inclusion/exclusion criteria will be enrolled. A trained research assistant will identify eligible patients and medications will be screened using MedSafer. A deprescribing plan will be generated for the CTU team containing the rationale for suggested medication changes and strategies for safe and successful deprescription. The CTU team will then decide, in conjunction with the patient/proxy and relevant consultants, whether to apply the suggested modifications.

Enrollment: 6,582 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 65 years and older
• patients who take five or more medications in the community
• patients who are cognitively impaired or otherwise unable to provide consent will still be included as this subpopulation of patients may be at greatest risk of ADEs because of their communication problems.

Exclusion criteria

• patients who take four or fewer medications in the community
• patients expected to die within 30 days or be transferred to a palliative care unit/another hospital
• patients without provincial health insurance or who normally live outside that province
• patients previously enrolled
• inability for patient or proxy to speak English or French
• no means of contacting patient or proxy post-discharge

Patients discharged from non-study units will be excluded unless that unit is a transitional care, rehabilitation, or post-acute care unit which bridges the gap between acute medical hospitalization and community services.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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6,582 participants in 2 patient groups

Control

No Intervention group

Description:

All participants in the control arm will receive medication reconciliation at admission and discharge, and identical follow up, but no prioritized deprescribing list will be generated.

Intervention

Experimental group

Description:

Participants in the intervention arm will be electronically screened using an electronic software "MedSafer" which will generate output of PIMs that will be brought to the attention of the CTU team via the unit pharmacist as "deprescribing opportunities". (Note that in the case of multiple recommendations, they will be limited and prioritized so as to avoid overwhelming the treating team.) Based on their own expert medical judgement, in collaboration with the patient/caregiver and other relevant clinicians, a decision will be made to deprescribe if appropriate by the patient's in-hospital doctors.

Treatment:

Other: Deprescribing opportunities