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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2020-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults

NCT02918058

Polypharmacy Deprescription Aged

COMPLETED NA

Deprescribing Intervention Among Nursing Home Residents With Major Neurocognitive Disorders

NCT05155748

Dementia

COMPLETED NA

Deprescribing in a Long Term Care Facility

NCT03091153

Polypharmacy

COMPLETED NA

Deprescribing in Primary Health Care

NCT03903484

Inappropriate Prescribing Primary Health Care Polypharmacy

COMPLETED NA

OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients

NCT05387096

Multimorbidity Polypharmacy

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Drug Event

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The duration of the project will be a total of (approx.) 96 weeks. This is a stepped wedge cluster randomized trial study design (see PDF attachment entitled "MedSafer, Figure 1" - note start date will be August 2017 not July 2016). The intervention component will be administered sequentially to six (6) clusters (by city). A randomly selected single cluster will move from control data collection to intervention data collection every 200 patients or roughly every 12 weeks (96 total weeks), which will be followed by 12 weeks to complete follow up and another 36 to analyze data.

Please see PDF attachment entitled "MedSafer, Figure 2" which refers to both parts of the study (quality improvement and follow up components). It describes the follow up component of the study (a 30-day telephone follow-up to ascertain adverse drug events- please note the gray-shaded boxes refer to the Quality Improvement Project-Part 1).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Medical chart abstracts compiled at discharge (including any subsequent visits within 30 days) will be combined with the patient telephone interview into a case summary report which will be reviewed independently by two trained and blinded clinician reviewers who will be made up of pharmacists and physicians from each study site (but who will not adjudicate any patients from their own site).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type EXPERIMENTAL

Deprescribing opportunities

Intervention Type OTHER

An electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deprescribing opportunities

An electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No