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Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults (MedSafer)

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ClinicalTrials.gov Identifier: NCT02918058
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
University Health Network, Toronto
The Ottawa Hospital
Information provided by (Responsible Party):
Todd Lee, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Polypharmacy Deprescription Aged Other: MedSafer Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults: a Multi-centre Electronic Deprescribing Intervention
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : June 15, 2017

Arm Intervention/treatment
Active Comparator: McGill University Health Centre
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
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.

Active Comparator: University Health Network, Toronto
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
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.

Active Comparator: University of Ottawa, Ottawa
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
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.




Primary Outcome Measures :
  1. Proportion of Patients with cessation of Potentially Inappropriate Medications (PIMs) [ Time Frame: Proportion will be evaluated on the day of the patient's discharge from the hospital ]
    The primary outcome is the proportion of patients with 1 or more PIM discontinued at discharge


Secondary Outcome Measures :
  1. The number of medications prescribed at discharge and 30 days post [ Time Frame: Within 30 days after the patient was discharged from the hospital ]
    The absolute number of medications prescribed at discharge and at 30 days post hospital discharge as compared to at admission

  2. Adverse drug event [ Time Frame: Within 30 days after the patient was discharged from the hospital ]
    An ADE is defined as an injury resulting from medical intervention related to a drug. ADEs will be assessed by trained clinician reviewers using the Leap-Bates method

  3. Adverse event [ Time Frame: Within 30 days after the patient was discharged from the hospital ]
    An adverse event is defined as an unplanned utilization of healthcare services, a death, and/or a new or worsening symptom concerning to the patient for which they intend to seek medical care

  4. Health related quality of life [ Time Frame: At 30 days after the patient was discharged from the hospital ]
    This will be assessed using the EQ-5D-5L Health Questionnaire.

  5. Length of stay (days) [ Time Frame: Duration of patient's hospital stay, from admission to discharge up to a maximum of 90 days ]
    Determination of hospital length of stay from enrollment into the study to discharge.

  6. Return to the emergency department [ Time Frame: At 30 days after the patient was discharged from the hospital ]
    Determination of whether participant returned to the emergency department after hospital discharge within 30 days of initial discharge.

  7. In-hospital mortality [ Time Frame: Throughout the index admission from time patient admitted to time patient discharged up to a maximum of 90 days ]
    In-hospital mortality during the index hospital admission.

  8. In hospital falls [ Time Frame: During patient's index admission, evaluated from admission to discharge, up to a maximum of 90 days ]
    Falls that are recorded while the patient is hospitalized

  9. 30-day all cause mortality [ Time Frame: At 30 days post hospital discharge ]
    Patients who die within 30 days of hospital discharge

  10. Proportion of potentially inappropriate medications at 30-days post discharge [ Time Frame: At 30 days post discharge ]
    Proportion of PIMs at 30-days post discharge as compared to proportion of PIMs at admission and at discharge



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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918058


Locations
Canada, Quebec
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
McGill University Health Center
University Health Network, Toronto
The Ottawa Hospital
Investigators
Principal Investigator: Todd C Lee, MD MPH McGill University Health Center

Additional Information:
Publications:
Responsible Party: Todd Lee, Associate Professor of Medicine, General Internal Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02918058     History of Changes
Other Study ID Numbers: 5433
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Todd Lee, McGill University Health Center:
Frailty
Deprescription