An interventional study of Deprescribing opportunities in Adverse Drug Event, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 7 sites in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Supportive care
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Among 30 studies in Drug-Related Side Effects and Adverse Reactions with a site in Canada — 5 open to participants now, 8 under way, none of them phase 3. Drug-Related Side Effects and Adverse Reactions · Canada.
Among the 30 studies in Drug-Related Side Effects and Adverse Reactions with a site in Canada, this one is the 2nd largest by enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2017, is one of 11 with no phase, and was the 19th registered.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
Browse Drug-Related Side Effects and Adverse Reactions studies →5 of the 30 studies in Drug-Related Side Effects and Adverse Reactions with a site in Canada are open now. Recruiting first, the newest first:
University of Manitoba · Sites in Canada
Ages 18+
University of Manitoba · Sites in Canada
Ages 6–24
University of British Columbia · Sites in Canada
St. Justine's Hospital · Sites in Canada
Ages up to 18
University of British Columbia · Sites in Canada
Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 55 Drug-Related Side Effects and Adverse Reactions studies recruiting now, 37 (67%) set no upper age limit and 15 (27%) stop at 75 or younger; 14 take children under 18; 4 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6,582 is above the median of 108 across 262 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Median enrollment 247 across the 18 interventional studies, 3,987 across the 12 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
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1 of 30 have an industry lead sponsor. The 10 most frequent:
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
McGill University Health Centre/Research Institute of the McGill University Health Centre has 3 studies filed under Drug-Related Side Effects and Adverse Reactions — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Drug-Related Side Effects and Adverse Reactions with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Reducing medications and associated side effects in older adults: an electronic hospital-based intervention
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Other: 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.
Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
Post-discharge telephone interview performed by trained personnel using a modification of the Australian two-step adverse reaction and drug event report. Two trained and blinded clinician reviewers will independently use the Leape and Bates approach to assess whether an ADE was present (yes/no) and if so what was the nature of the injury resulting from it using a four-point Likert scale (definitely preventable, probably preventable, probably not preventable, and definitely not preventable), and assess the probability that an event was attributable to a specific drug that was newly started, changed or continued during hospitalization. In cases of disagreement, a third trained and blinded clinician will review and determine the final assessment.
Time frame: Interview performed 30-35 days post-discharge.
Number of potentially inappropriate medications
The absolute number of potentially inappropriate medications at discharge among patients who were identified as having a potentially inappropriate medication at admission and for who a deprescribing opportunity was generated and presented to the treating team
Time frame: At hospital discharge and at 30-days post hospital discharge
Mortality within 30-days post discharge
Death following hospital discharge
Time frame: 30-days post hospital discharge
Proportion of participants with one or more potentially inappropriate medications deprescribed
Proportion of participants with one or more potentially inappropriate medications deprescribed at discharge between intervention and control
Time frame: At hospital discharge
Quality of sleep
Quality of sleep measured by the PROMIS Sleep Disturbance 4a measured pre- and post-hospitalization compared between intervention and control
Time frame: 30 days post hospital discharge
Adverse events
The proportion of patients who had one or more adverse events (falls, hospitalization, death, unplanned encounter with the healthcare system
Time frame: 30 days post hospital discharge
Falls post hospital discharge
The proportion of patients with one or more self-reported falls post hospital discharge
Time frame: 30 days post hospital
Quality of life of participants
Quality of life as measured by EQ5D-5L and reported based on reported Canadian time trade-off values (from 0-1 with higher equal to better quality of life)
Time frame: At 30-days post hospital discharge
Death post hospital discharge
Proportion of patients who died post-hospital discharge compared between the intervention and control groups
Time frame: 30-days post hospital discharge
Unplanned visits with the healthcare system
Proportion of patients with any self-reported unplanned visit with the healthcare system compared between intervention and control (emergency room visits and hospitalizations)
Time frame: 30-days post hospital discharge
Total number of medications at 30-days
Total number of mediations at 30 days (reported as median and interquartile range) compared between intervention and control
Time frame: At 30-days post discharge
Sensitivity analysis for adverse drug events
Proportion of participants with 1 or more adverse drug events as defined by 4 or more on the 6-point Leape and Bates Likert scale
Time frame: At 30-days post hospital discharge
Proportion of potentially inappropriate medications that remained stopped
Proportion of potentially inappropriate medications that remained stopped between intervention and control
Time frame: 30-days post hospital discharge
Plan to share: Yes — We will keep a coded, completely anonymized, database that will be made available to other researchers upon request.
Supporting information: Study protocol, Informed consent form
Time frame: Eighteen (18) months following the study completion.
Ran from Aug 2017 to primary completion in Mar 2020, 31 months.
Of 71 non-industry interventional studies with no phase under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 31 months is close to that.
Counting every sponsor, half of 73 studies reached it within 26 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Drug-Related Side Effects and Adverse Reactions →
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