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MedSafer E-care: an Automated Deprescribing Solution (E-CARE Study) (E-CARE)

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ClinicalTrials.gov Identifier: NCT04087109
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
MED e-care Healthcare Solutions
OMNI Health Care
Centre for Aging and Brain Health Innovation
Information provided by (Responsible Party):
Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The investigators will link MedSafer (a Canadian-made electronic tool) with a large multi-national electronic medical record (EMR), MED e-care, through an existing application programming interface (API) that provides clinicians with electronic, patient-specific deprescribing reports. They will implement a highly scalable deprescribing intervention in a staged and controlled fashion across five Canadian Aged Care Facilities. The investigators aim to test the feasibility of the API for the purposes of generating real time automated deprescribing reports, displayed to the user in the EMR.

Condition or disease Intervention/treatment Phase
Polypharmacy Deprescribing Adverse Drug Event Other: Electronic decision support for deprescribing (MedSafer tool) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge randomized control trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator will receive anonymous data and when performing the analysis will not know if the participant received the intervention or not. The same is true for the outcome assessor (blinded to study intervention). All patient and time identifiers stripped from the outcome adjudication.
Primary Purpose: Prevention
Official Title: MedSafer E-care: an Automated Deprescribing Solution for Community-dwelling Older Adults Living With Polypharmacy (E-CARE Study)
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention: MedSafer
In the intervention phase, the MedSafer feature will become accessible in MED e-care for the physicians, pharmacists and nurses. This feature will provide health care professionals with individualized and prioritized deprescribing opportunities: a) identifying the medication, b) explaining why that medication is potentially inappropriate and c) providing instructions on how to safely stop/taper the medication. The user will review these opportunities and appropriate candidate medications for deprescribing can then be tapered or stopped directly in the EMR. During the intervention phase, all patients will receive the educational (EMPOWER) brochures as applicable to the medications they are taking (PPI, sedative-hypnotic, antihistamine, antipsychotic, sulfonylurea, NSAID, opioid/narcotic).
Other: Electronic decision support for deprescribing (MedSafer tool)
During the intervention phase, MedSafer will provide users with individualized and prioritized deprescribing opportunities: a) identifying the medication, b) explaining why that medication is potentially inappropriate and c) providing instructions on how to safely stop/taper the medication. The user will review these opportunities and appropriate candidate medications for deprescribing can then be tapered or stopped directly in the EMR. Patients or proxy will also receive educational medications brochures (EMPOWER) from the research assistant or staff at the nursing home, as applicable to the medications they are taking (PPI, sedative-hypnotic, antipsychotic, antihistamine, sulfonylurea, NSAID, opioid/narcotic).

No Intervention: Control: Baseline (no MedSafer)
During the control phase, the MedSafer application programming interface will not be accessible to the caretakers at the aged care facilities (ACF). This serves to obtain baseline deprescribing levels for each ACF.



Primary Outcome Measures :
  1. Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped [ Time Frame: 30-days after the prescriber receives a deprescribing report. ]
    Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped 30-days after the treating physician receives a deprescribing report.


Secondary Outcome Measures :
  1. Sustainability; quality of life; sleep quality; falls; transfer to acute hospital; hip fractures; and delirium [ Time Frame: Examined at 30-days following each intervention cycle (3 cycles) ]
    Proportion of patients with one or more PIM reduced or stopped following each cycle (sustainability); quality of life; sleep quality; falls; transfer to acute hospital; hip fractures; and delirium


Other Outcome Measures:
  1. Cost savings [ Time Frame: 1 year ]
    Cost savings analysis related to cost saved from medications (actual price of the medication as well as dispensing fees) and cost savings from prevention of adverse drug events, balanced with the cost of deployment of MedSafer, including maintaining the program with updates and user support, new data generated from studies and latest recommendations for deprescribing from scientific bodies.



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

Inclusion Criteria:

  • All residents of the participating Ontario long term care facilities (OMNI) who are 65 years of age or older and are taking a potentially inappropriate medication (as identified by MedSafer) are eligible for the deprescribing component of this study.

Exclusion Criteria:

  • If a patient is unable to complete the survey due to a language barrier or cognitive impairment, the research assistant will seek consent from an appropriate proxy. In the event where both the patient and proxy are unable to complete the survey or there was no proxy identified or proxy could not be reached, the patient will be excluded from the survey component of the study. The health care professionals will still have access to their MedSafer file for the purposes of patient care.

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): NCT04087109


Contacts
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Contact: Emily McDonald, MDCM 514-934-1934 ext 53333 emily.mcdonald@mcgill.ca

Locations
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Canada, Ontario
OMNI homes Recruiting
Toronto, Ontario, Canada
Contact: Marie Hewitt    416-618-8563    marie@initiative3.com   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
MED e-care Healthcare Solutions
OMNI Health Care
Centre for Aging and Brain Health Innovation
Investigators
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Principal Investigator: Emily McDonald, MDCM McGill University Health Centre/Research Institute of the McGill University Health Centre
Additional Information:
Publications:
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Responsible Party: Emily McDonald, Assistant Professor of Medicine, Director of General Internal Medicine Consult Service (Royal Victoria Hospital), McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04087109    
Other Study ID Numbers: 2019-5062
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non-pharma academic researchers may contact the principal investigator by email one year following the primary publication for access to data which will be shared via password-protected excel document.
Supporting Materials: Study Protocol
Time Frame: Made available for 1 year following the publication of the primary manuscript from the trial
Access Criteria: Contact study primary investigator at emily.mcdonald@mcgill.ca

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders