NCT02918058

Brief Summary

Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among older adults and especially those classified as frail. ADEs are responsible for nearly 27,000 hospital admissions in Canada annually. Within 30 days of discharge, medications contribute to two-thirds of adverse events, with nearly 60% being preventable or ameliorable. MedSafer is software product that guides patients and physicians in the community through the process of deprescribing. MedSafer electronically cross-references patient comorbidities with the most recent evidence-based PIMs, as of the study date, in order to generate a patient-tailored deprescribing care plan. This study will evaluate whether this application, when applied at hospitalization, leads to a reduction in the proprotion of patients with PIMs prescribed at discharge, by highlighting harmful medications for deprescription to treating physicians. This study will take place on the clinical teaching units (CTUs) at four hospitals. Based on historical records, the investigators estimate enrolling 480 patients aged 65 or older over three months. A trained research assistant will identify eligible patients, and will enter their medications, comorbidities, and an estimate of frailty into MedSafer. A deprescribing plan will be generated for the CTU team containing rationale for suggested medication changes and strategies for safe and successful deprescription. The CTU team will then decide in conjunction with the patient or proxy, and with relevant consultants, which medications can rationally be stopped or tapered at discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
924

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

September 13, 2016

Last Update Submit

April 13, 2018

Conditions

PolypharmacyDeprescriptionAged

Keywords

FrailtyDeprescription

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients with cessation of Potentially Inappropriate Medications (PIMs)

    The primary outcome is the proportion of patients with 1 or more PIM discontinued at discharge

    Proportion will be evaluated on the day of the patient's discharge from the hospital

Secondary Outcomes (10)

  • The number of medications prescribed at discharge and 30 days post

    Within 30 days after the patient was discharged from the hospital

  • Adverse drug event

    Within 30 days after the patient was discharged from the hospital

  • Adverse event

    Within 30 days after the patient was discharged from the hospital

  • Health related quality of life

    At 30 days after the patient was discharged from the hospital

  • Length of stay (days)

    Duration of patient's hospital stay, from admission to discharge up to a maximum of 90 days

  • +5 more secondary outcomes

Study Arms (3)

McGill University Health Centre

ACTIVE COMPARATOR

This arm is defined by the geographic cluster of all eligible participants presenting to the McGill University Health Centre (Montreal, Quebec, Canada) Montreal General Hospital or Royal Victoria Hospital during the study period. The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.

Other: MedSafer

University Health Network, Toronto

ACTIVE COMPARATOR

This arm is defined by the geographic cluster of all eligible participants presenting to the University Health Network (Toronto, Ontario, Canada) at the Toronto General Hospital or Toronto Western Hospital. The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.

Other: MedSafer

University of Ottawa, Ottawa

ACTIVE COMPARATOR

This arm is defined by the geographic cluster of all eligible participants presenting to the Ottawa Hospital (Ottawa, Ontario, Canada). The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.

Other: MedSafer

Interventions

MedSaferOTHER

MedSafer is an electronic tool for the treating team (physician and pharmacists) to facilitate medication deprescription. MedSafer can identify potentially inappropriate medication use and communicate the risk of adverse drug events to the treating team.

McGill University Health CentreUniversity Health Network, TorontoUniversity of Ottawa, Ottawa

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants will represent a consecutive series of persons.
  • Eligible participants include those who are:
  • aged 65 years or older;
  • taking 5 or more medications; and
  • admitted to the inpatient medical ward at any of the study sites.
  • Patients who are cognitively impaired or otherwise unable to provide consent will still be included as this sub-population of patients may be at greatest risk of ADEs because of their communication problems. Tri-council ethics guidelines (Canada) deem that this sub-population should not be excluded from interventions that potentially provide direct benefit to the participant due to the inability to provide informed consent (Article 4.5, Tri-Council Policy Statement 2008). For these patients, the family/proxy will authorize study participation pending the return of patient capacity to consent.
  • Patients who are ultimately discharged from non-study units during their hospitalization will be excluded unless that unit is a transitional care, rehabilitation, or post-acute care unit used to bridge the gap between acute medical hospitalization and community services.

You may not qualify if:

  • patients expected to be transferred to another acute care hospital, a non-medical unit, or a palliative care unit;
  • patients who normally live outside of the province of hospitalization;
  • patients not enrolled in (or eligible for) the provincial drug plans;
  • patients previously enrolled in the study;
  • patients or proxy not able to speak English or French;
  • no means of contacting patient or proxy post-discharge;
  • patients expected to die within 30 days and whose level of care has been declared to be palliative will be maintained in the study but will be excluded from select secondary outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (5)

  • Gallagher PF, O'Connor MN, O'Mahony D. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria. Clin Pharmacol Ther. 2011 Jun;89(6):845-54. doi: 10.1038/clpt.2011.44. Epub 2011 Apr 20.

    PMID: 21508941BACKGROUND

  • Lee TC, Frenette C, Jayaraman D, Green L, Pilote L. Antibiotic self-stewardship: trainee-led structured antibiotic time-outs to improve antimicrobial use. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S53-8. doi: 10.7326/M13-3016.

    PMID: 25402404BACKGROUND

  • McDonald EG, Jones J, Green L, Jayaraman D, Lee TC. Reduction of inappropriate exit prescriptions for proton pump inhibitors: A before-after study using education paired with a web-based quality-improvement tool. J Hosp Med. 2015 May;10(5):281-6. doi: 10.1002/jhm.2330. Epub 2015 Feb 24.

    PMID: 25708942BACKGROUND

  • Interagency_Advisory_Panel_on_Research_Ethics. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Interagency Secretariat on Research Ethics; 2008.

    BACKGROUND

  • McDonald EG, Wu PE, Rashidi B, Forster AJ, Huang A, Pilote L, Papillon-Ferland L, Bonnici A, Tamblyn R, Whitty R, Porter S, Battu K, Downar J, Lee TC. The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care. J Am Geriatr Soc. 2019 Sep;67(9):1843-1850. doi: 10.1111/jgs.16040. Epub 2019 Jun 27.

    PMID: 31250427DERIVED

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological 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
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, General Internal Medicine

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

May 15, 2017

Study Completion

June 15, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)