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

October 31, 2023 updated by: Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

MedSafer E-care: an Automated Deprescribing Solution for Community-dwelling Older Adults Living With Polypharmacy (E-CARE Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

MedSafer is a Canadian-made electronic tool that automates deprescribing and generates individualized, prioritized deprescribing opportunities for older adults based on existing evidence from algorithms such as the Beer's criteria and STOPP/START in order to stop potentially inappropriate medications. Its clinical content has been in place for over a year in a Canadian Institutes for Health Research funded study and has been tested on over 5000 hospitalized patients. Software output has been analyzed and validated by Canadian experts in internal medicine, geriatrics, palliative care, nursing, and pharmacy.

In the previous study funded by the Canadian Institutes for Health Research (expected total recruitment: 6000), while deprescribing reports were generated automatically, data still had to be entered manually, by trained research assistants. For this study, the next stage of development involved creating an API that could accept medical conditions in the format of ICD10 codes and medications as DINs.

"MedSafer e-Care" addresses the needs of patients and caretakers by facilitating safe deprescribing. Deprescribing is time consuming, complex, and not all caretakers (clinicians) are trained with the expert knowledge required to cross reference multiple medical conditions with often 10 or more medications. "MED e-care" is an EMR (electronic medical record) that contains patient medical conditions and medications stored as international disease classification codes (ICD10) and drug identification numbers (DIN). The MedSafer team has designed an API that cross-references ICD10 codes and DINs against existing evidence-based algorithms for safe deprescribing. The API has been tested on a variety of medical conditions and medications contained within the MedSafer rule set. This process can overcome barriers to stopping medications including caretaker time constraints and knowledge gaps.

Data packets are processed by the MedSafer API and deprescribing reports are returned to MED e-care and displayed to the user on the EMR interface. Reports will be available to caretakers (nurses, physicians and pharmacists) who can choose to stop or taper medications within the EMR. Opportunities are prioritized based on potential for harm and ease of discontinuation, and factor in a measure of patient frailty and life expectancy. When necessary, instructions for tapering medications are provided. Links to patient educational brochures are included and can be printed for the patient and family detailing harmful medications and deprescribing rationale. MED e-care has already entered negotiations with the nursing home group OMNI Health Care to recruit at least five and up to 18 of the 18 care sites from within the OMNI group of homes across Ontario.

The estimated duration of the study is 12 months. Deployment will approximate a Stepped Wedge Cluster Randomized Trial Design (calculations performed with steppedwedge function in Stata v. 15). To accomplish this, at least 10 unique patients would need to be enrolles per ACF every 2 months following a 3-month baseline period (minimum total 300 patients).

The 5 OMNI ACFs will be grouped in 3 clusters. During the control phase, the MedSafer API will not be accessible to the caretakers at the ACF. This serves to obtain baseline deprescribing levels for each ACF. When the first cluster completes its baseline phase, the MedSafer API feature will become accessible in MED e-care for the physicians, pharmacists and nurses. Staff at the ACFs will receive a communiqué before entering the intervention phase as well as a brief training on how to access this feature in the EMR. Following a 3 month intervention period, the 2nd cluster will switch from its baseline phase to intervention. The last cluster will enter the intervention phase 3 months after that. Once in the intervention phase, users will receive quarterly deprescribing reports for their patients. MED e-care will selectively allow access to the MedSafer feature for each site when it is their turn to enter the intervention phase.

Cluster 1: 3 months control + 9 months intervention

Cluster 2: 6 months control + 6 months intervention

Cluster 3: 9 months control + 3 months intervention

During the control phase, residents at the 5 nursing homes or their proxy will be contacted by a trained research assistant who will ask them to participate in the study. Their participation will consist of a survey regarding their attitude towards deprescribing.

During the intervention phase, staff at the nursing homes (nurse, pharmacist, physician) will be asked to distribute educational brochures regarding medications to patients/proxies, as applicable to the medications the patient is taking.

During the intervention phase, this feature 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.

Structured feedback about MedSafer deprescribing opportunities is important and imperative to optimize success and sustainability of any deprescribing intervention. Working with the user, through rapid cycle interventions, the investigators will curate an output that minimizes alert fatigue and is acceptable to stakeholders (caretakers/clinicians). Users of the MedSafer feature will include physicians, pharmacists and nurses, including nurse practitioners, at the 5 OMNI long-term care facilities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • OMNI homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30-days after the prescriber receives a deprescribing report.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Examined at 30-days following each intervention cycle (3 cycles)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Aging and Brain Health Innovation
MED e-care Healthcare Solutions
OMNI Health Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily McDonald, MDCM, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-5062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Made available for 1 year following the publication of the primary manuscript from the trial

IPD Sharing Access Criteria

Contact study primary investigator at emily.mcdonald@mcgill.ca

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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