Adverse Drug EventNCT03272607
Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
A study testing Deprescribing opportunities in people with Adverse Drug Event, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in Canada.
Trial summary
Reducing medications and associated side effects in older adults: an electronic hospital-based intervention Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- Deprescribing opportunities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,582 participants
- Where
- 7 sitesCanada
- Study dates
- 22 Aug 2017to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Foothills Medical Centre, Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta, Edmonton
Edmonton, Alberta, T6G 2G3
Kingston General Hospital
Kingston, Ontario, K7L 2V7
McGill University Health Centre
Montreal, Quebec, H4A 3J1
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
University Health Network, Toronto
Toronto, Ontario, M5T 2S8
University of British Columbia, St-Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Reducing medications and associated side effects in older adults: an electronic hospital-based intervention
Read the detailed 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.
- Conditions
- Adverse Drug Event
- Being tested
- Deprescribing opportunities
- Keywords
- Adverse Drug Event, Choosing Wisely Canada, Deprescribing, Elderly, Frailty, High value healthcare, Medication rationalization, Medication stewardship, Polypharmacy
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing opportunitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | 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. Receives: Other: Deprescribing opportunities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Interview performed 30-35 days post-discharge.
Secondary outcomes (7)
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
Measured: At hospital discharge and at 30-days post hospital discharge
Mortality within 30-days post discharge
Death following hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days post hospital discharge
Falls post hospital discharge
The proportion of patients with one or more self-reported falls post hospital discharge
Measured: 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)
Measured: At 30-days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start22 Aug 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, The Ottawa Hospital, Foothills Medical Centre, University of Alberta, Kingston Health Sciences Centre, University of British Columbia
- Responsible party
- Principal investigator, Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Todd C Lee, MD, MPH, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272607
- Sponsor's protocol ID
- MedSafer
- Other IDs
- CIHR Application No. 365795
- Status last verified
- May 2021
- First submitted
- 31 Aug 2017
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will keep a coded, completely anonymized, database that will be made available to other researchers upon request.
Publications
Desormeau B, Huang A, Downar J, Wu PE, Bortolussi-Courval E, Ross SB, Battu K, Papillon-Ferland L, McAlister FA, Elsayed S, Wilson MG, Cavalcanti RB, McDonald EG, Lee TC. Prescribing Patterns and Impact of Sedatives in Hospitalized Older Adults: A Secondary Analysis of the MedSafer Study. J Am Geriatr Soc. 2025 Jun;73(6):1753-1761. doi: 10.1111/jgs.19437. Epub 2025 Mar 23.
PubMed 40123160McDonald EG, Wu PE, Rashidi B, Wilson MG, Bortolussi-Courval E, Atique A, Battu K, Bonnici A, Elsayed S, Wilson AG, Papillon-Ferland L, Pilote L, Porter S, Murphy J, Ross SB, Shiu J, Tamblyn R, Whitty R, Xu J, Fabreau G, Haddad T, Palepu A, Khan N, McAlister FA, Downar J, Huang AR, MacMillan TE, Cavalcanti RB, Lee TC. The MedSafer Study-Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):265-273. doi: 10.1001/jamainternmed.2021.7429.
PubMed 35040926
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
- ClinicalTrials.gov ID
- NCT03272607
- Acronym / sponsor ID
- MedSafer
- Conditions
- Adverse Drug Event
- Keywords
- Adverse Drug Event, Choosing Wisely Canada, Deprescribing, Elderly, Frailty, High value healthcare, Medication rationalization, Medication stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,582 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, The Ottawa Hospital, Foothills Medical Centre, University of Alberta, Kingston Health Sciences Centre, University of British Columbia
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing medications and associated side effects in older adults: an electronic hospital-based intervention
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Other: Deprescribing opportunitiesParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing opportunitiesAn electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration. | Other | Intervention |
Primary outcome
Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
Time frame: Interview performed 30-35 days post-discharge.
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.
7 secondary outcomes
Number of potentially inappropriate medications
Time frame: At hospital discharge and at 30-days post hospital discharge
Mortality within 30-days post discharge
Time frame: 30-days post hospital discharge
Proportion of participants with one or more potentially inappropriate medications deprescribed
Time frame: At hospital discharge
Quality of sleep
Time frame: 30 days post hospital discharge
Adverse events
Time frame: 30 days post hospital discharge
Falls post hospital discharge
Time frame: 30 days post hospital
Quality of life of participants
Time frame: At 30-days post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 40123160Desormeau B, Huang A, Downar J, Wu PE, Bortolussi-Courval E, Ross SB, Battu K, Papillon-Ferland L, McAlister FA, Elsayed S, Wilson MG, Cavalcanti RB, McDonald EG, Lee TC. Prescribing Patterns and Impact of Sedatives in Hospitalized Older Adults: A Secondary Analysis of the MedSafer Study. J Am Geriatr Soc. 2025 Jun;73(6):1753-1761. doi: 10.1111/jgs.19437. Epub 2025 Mar 23.
- Derived from this study: PubMed 35040926McDonald EG, Wu PE, Rashidi B, Wilson MG, Bortolussi-Courval E, Atique A, Battu K, Bonnici A, Elsayed S, Wilson AG, Papillon-Ferland L, Pilote L, Porter S, Murphy J, Ross SB, Shiu J, Tamblyn R, Whitty R, Xu J, Fabreau G, Haddad T, Palepu A, Khan N, McAlister FA, Downar J, Huang AR, MacMillan TE, Cavalcanti RB, Lee TC. The MedSafer Study-Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):265-273. doi: 10.1001/jamainternmed.2021.7429.
- Individual participant dataSharing planned: Yes. We will keep a coded, completely anonymized, database that will be made available to other researchers upon request.
Related trials for Adverse Drug Event
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Recruiting
Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)
Solid Tumor Malignancies, Solid Cancers
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd C Lee, MD, MPH principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprescribing opportunities in people with Adverse Drug Event, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers) (time frame: Interview performed 30-35 days post-discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.