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

Adverse Drug Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272607
• Other study ID #: MedSafer
• Secondary ID: CIHR Application
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6582
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre, Calgary	Calgary	Alberta
Canada	University of Alberta, Edmonton	Edmonton	Alberta
Canada	Kingston General Hospital	Kingston	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	University Health Network, Toronto	Toronto	Ontario
Canada	University of British Columbia, St-Paul's Hospital	Vancouver	British Columbia

Sponsors (8)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR), Foothills Medical Centre, Kingston Health Sciences Centre, The Ottawa Hospital, University Health Network, Toronto, University of Alberta, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death post hospital discharge	Proportion of patients who died post-hospital discharge compared between the intervention and control groups	30-days post hospital discharge
Other	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)	30-days post hospital discharge
Other	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	At 30-days post discharge
Other	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	At 30-days post hospital discharge
Other	Proportion of potentially inappropriate medications that remained stopped	Proportion of potentially inappropriate medications that remained stopped between intervention and control	30-days post hospital discharge
Primary	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.	Interview performed 30-35 days post-discharge.
Secondary	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	At hospital discharge and at 30-days post hospital discharge
Secondary	Mortality within 30-days post discharge	Death following hospital discharge	30-days post hospital discharge
Secondary	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	At hospital discharge
Secondary	Quality of sleep	Quality of sleep measured by the PROMIS Sleep Disturbance 4a measured pre- and post-hospitalization compared between intervention and control	30 days post hospital discharge
Secondary	Adverse events	The proportion of patients who had one or more adverse events (falls, hospitalization, death, unplanned encounter with the healthcare system	30 days post hospital discharge
Secondary	Falls post hospital discharge	The proportion of patients with one or more self-reported falls post hospital discharge	30 days post hospital
Secondary	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)	At 30-days post hospital discharge