Clinical trial NCT03272607: Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
Official title: Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Event
Keywords: Adverse Drug Event
Choosing Wisely Canada
Deprescribing
Elderly
Frailty
High value healthcare
Medication rationalization
Medication stewardship
Polypharmacy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University Health Network, Toronto
name: The Ottawa Hospital
name: Foothills Medical Centre
name: University of Alberta
name: Kingston Health Sciences Centre
name: University of British Columbia
First posted: 2017-09-05
Enrollment: 6582
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
timeFrame: Interview performed 30-35 days post-discharge.
Secondary outcomes:
measure: Number of potentially inappropriate medications
timeFrame: At hospital discharge and at 30-days post hospital discharge
measure: Mortality within 30-days post discharge
timeFrame: 30-days post hospital discharge
measure: Proportion of participants with one or more potentially inappropriate medications deprescribed
timeFrame: At hospital discharge
measure: Quality of sleep
timeFrame: 30 days post hospital discharge
measure: Adverse events
timeFrame: 30 days post hospital discharge
measure: Falls post hospital discharge
timeFrame: 30 days post hospital
measure: Quality of life of participants
timeFrame: At 30-days post hospital discharge
Other outcomes:
measure: Death post hospital discharge
timeFrame: 30-days post hospital discharge
measure: Unplanned visits with the healthcare system
timeFrame: 30-days post hospital discharge
measure: Total number of medications at 30-days
timeFrame: At 30-days post discharge
measure: Sensitivity analysis for adverse drug events
timeFrame: At 30-days post hospital discharge
measure: Proportion of potentially inappropriate medications that remained stopped
timeFrame: 30-days post hospital discharge
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre, Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta, Edmonton
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia, St-Paul's Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Todd C Lee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonald 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.