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

NCT04087109 | Withdrawn

• 1 other identifier: 2019-5062
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Deprescribing; Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped

  Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped 30-days after the treating physician receives a deprescribing report.

  30-days after the prescriber receives a deprescribing report.

Secondary Outcomes (1)

• Sustainability; quality of life; sleep quality; falls; transfer to acute hospital; hip fractures; and delirium

  Examined at 30-days following each intervention cycle (3 cycles)

Other Outcomes (1)

• Cost savings

  1 year

Study Arms (2)

Intervention: MedSafer

EXPERIMENTAL

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)

Control: Baseline (no MedSafer)

NO INTERVENTION

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.

Interventions

Electronic decision support for deprescribing (MedSafer tool) OTHER

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).

Intervention: MedSafer

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• MED e-care Healthcare Solutions: collaborator
• OMNI Health Care: collaborator
• Centre for Aging and Brain Health Innovation: collaborator

Study Sites (1)

OMNI homes

Toronto, Ontario, Canada

Location

Related Publications (5)

• Tam SHY, Hirsch JD, Watanabe JH. Medication Regimen Complexity in Long-Term Care Facilities and Adverse Drug Events-Related Hospitalizations. Consult Pharm. 2017 May 1;32(5):281-284. doi: 10.4140/TCP.n.2017.281.

  PMID: 28483008 BACKGROUND

• Dwyer LL, Han B, Woodwell DA, Rechtsteiner EA. Polypharmacy in nursing home residents in the United States: results of the 2004 National Nursing Home Survey. Am J Geriatr Pharmacother. 2010 Feb;8(1):63-72. doi: 10.1016/j.amjopharm.2010.01.001.

  PMID: 20226393 BACKGROUND

• Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr. 2009 Jan 28;9:5. doi: 10.1186/1471-2318-9-5.

  PMID: 19175914 BACKGROUND

• By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. doi: 10.1111/jgs.13702. Epub 2015 Oct 8.

  PMID: 26446832 BACKGROUND

• O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.

  PMID: 25324330 BACKGROUND

Related Links

• Study website
• EMPOWER brochures
• Choosing Widely Canada

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Deprescriptions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Emily McDonald, MDCM

  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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Director of General Internal Medicine Consult Service (Royal Victoria Hospital)

Model Details: Stepped wedge randomized control trial

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

CA (1)