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

NCT03272607 | Completed DMC

• 2 other identifiers: MedSaferCIHR Application No. 365795
• Study Type: interventional
• Target: 6,582
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Adverse Drug Event

Keywords

Adverse Drug Event; Choosing Wisely Canada; Deprescribing; Elderly; Frailty; High value healthcare; Medication rationalization; Medication stewardship; Polypharmacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of potentially inappropriate medications

  At hospital discharge and at 30-days post hospital discharge

• Mortality within 30-days post discharge

  30-days post hospital discharge

• Proportion of participants with one or more potentially inappropriate medications deprescribed

  At hospital discharge

• Quality of sleep

  30 days post hospital discharge

• Adverse events

  30 days post hospital discharge

Other Outcomes (5)

• Death post hospital discharge

  30-days post hospital discharge

• Unplanned visits with the healthcare system

  30-days post hospital discharge

• Total number of medications at 30-days

  At 30-days post discharge

Study Arms (2)

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.

Other: Deprescribing opportunities

Interventions

Deprescribing opportunities 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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University Health Network, Toronto: collaborator
• The Ottawa Hospital: collaborator
• Foothills Medical Centre: collaborator
• University of Alberta: collaborator
• Kingston Health Sciences Centre: collaborator
• University of British Columbia: collaborator

Study Sites (7)

Foothills Medical Centre, Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta, Edmonton

Edmonton, Alberta, T6G 2G3, Canada

Location

University of British Columbia, St-Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network, Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• 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.

  PMID: 35040926 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Frailty

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd C Lee, MD, MPH

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Emily McDonald, Assistant Professor of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: August 22, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Eighteen (18) months following the study completion.

Locations

CA (7)