<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272607</url>
  </required_header>
  <id_info>
    <org_study_id>MedSafer</org_study_id>
    <secondary_id>CIHR Application No. 365795</secondary_id>
    <nct_id>NCT03272607</nct_id>
  </id_info>
  <brief_title>Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention</brief_title>
  <official_title>Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foothills Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reducing medications and associated side effects in older adults: an electronic&#xD;
      hospital-based intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polypharmacy, or the concomitant use of 5 drugs or more, is a serious health concern and&#xD;
      affects more than half of Canadians aged 65 years and older. It is the number one&#xD;
      identifiable risk factor for adverse drug events (ADEs), which are responsible for 27,000&#xD;
      hospital admissions annually in Canada and up to 20% of return visits to the hospital within&#xD;
      30 days of discharge. Many ADEs are preventable or ameliorable through interventions to&#xD;
      reduce inappropriate prescribing.&#xD;
&#xD;
      MedSafer, the intervention software, applies an electronic set of criteria, previously&#xD;
      designed and piloted on one thousand (1000) hospitalized patients by a group of Quebec and&#xD;
      Ontario internists, geriatricians, palliative care doctors and pharmacists, to identify&#xD;
      potentially inappropriate medications (PIMs) in the hospitalized elderly and generate&#xD;
      instructions for the patient and physician for safe discontinuation. The current study seeks&#xD;
      to partially automate the deprescribing process and to demonstrate the efficacy of this type&#xD;
      of intervention on adverse drug events at 30-days post hospital discharge.&#xD;
&#xD;
      At the time of hospitalization, the patient's medications, co-morbidities, and a measure of&#xD;
      frailty will be entered into the MedSafer software which will output an individualized and&#xD;
      prioritized deprescription plan for the most responsible physician's consideration. Any&#xD;
      subsequent medication changes will be transmitted to relevant community physicians. The study&#xD;
      will evaluate the impact of stopping PIMs on the occurrence of ADEs within 30 days of&#xD;
      discharge, as compared to usual care.&#xD;
&#xD;
      This study will take place on the clinical teaching units (CTUs) at 11 hospitals from seven&#xD;
      university hospital centres across Canada. Based on historical data, the investigators&#xD;
      estimate a combined 5200 eligible patients per year with nearly 50% taking ten or more&#xD;
      medications. Many will have multiple medical co-morbidities such as diabetes, heart disease,&#xD;
      and renal insufficiency. A large portion will meet criteria for geriatric syndromes such as&#xD;
      frailty and will be at high risk for the development of delirium, falls and functional&#xD;
      decline. This population is ideal for a generalizable deprescribing study.&#xD;
&#xD;
      All patients aged 65 or older who meet inclusion/exclusion criteria will be enrolled. A&#xD;
      trained research assistant will identify eligible patients and medications will be screened&#xD;
      using MedSafer. A deprescribing plan will be generated for the CTU team containing the&#xD;
      rationale for suggested medication changes and strategies for safe and successful&#xD;
      deprescription. The CTU team will then decide, in conjunction with the patient/proxy and&#xD;
      relevant consultants, whether to apply the suggested modifications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>The duration of the project will be a total of (approx.) 96 weeks. This is a stepped wedge cluster randomized trial study design (see PDF attachment entitled &quot;MedSafer, Figure 1&quot; - note start date will be August 2017 not July 2016). The intervention component will be administered sequentially to six (6) clusters (by city). A randomly selected single cluster will move from control data collection to intervention data collection every 200 patients or roughly every 12 weeks (96 total weeks), which will be followed by 12 weeks to complete follow up and another 36 to analyze data.&#xD;
Please see PDF attachment entitled &quot;MedSafer, Figure 2&quot; which refers to both parts of the study (quality improvement and follow up components). It describes the follow up component of the study (a 30-day telephone follow-up to ascertain adverse drug events- please note the gray-shaded boxes refer to the Quality Improvement Project-Part 1).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Medical chart abstracts compiled at discharge (including any subsequent visits within 30 days) will be combined with the patient telephone interview into a case summary report which will be reviewed independently by two trained and blinded clinician reviewers who will be made up of pharmacists and physicians from each study site (but who will not adjudicate any patients from their own site).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)</measure>
    <time_frame>Interview performed 30-35 days post-discharge.</time_frame>
    <description>Post-discharge telephone interview performed by trained personnel using a modification of the Australian two-step adverse reaction and drug event report.&#xD;
Two trained and blinded clinician reviewers will independently use the Leape and Bates approach to assess whether an ADE was present (yes/no) and if so what was the nature of the injury resulting from it using a four-point Likert scale (definitely preventable, probably preventable, probably not preventable, and definitely not preventable), and assess the probability that an event was attributable to a specific drug that was newly started, changed or continued during hospitalization. In cases of disagreement, a third trained and blinded clinician will review and determine the final assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of potentially inappropriate medications</measure>
    <time_frame>At hospital discharge and at 30-days post hospital discharge</time_frame>
    <description>The absolute number of potentially inappropriate medications at discharge among patients who were identified as having a potentially inappropriate medication at admission and for who a deprescribing opportunity was generated and presented to the treating team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality within 30-days post discharge</measure>
    <time_frame>30-days post hospital discharge</time_frame>
    <description>Death following hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with one or more potentially inappropriate medications deprescribed</measure>
    <time_frame>At hospital discharge</time_frame>
    <description>Proportion of participants with one or more potentially inappropriate medications deprescribed at discharge between intervention and control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>30 days post hospital discharge</time_frame>
    <description>Quality of sleep measured by the PROMIS Sleep Disturbance 4a measured pre- and post-hospitalization compared between intervention and control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days post hospital discharge</time_frame>
    <description>The proportion of patients who had one or more adverse events (falls, hospitalization, death, unplanned encounter with the healthcare system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls post hospital discharge</measure>
    <time_frame>30 days post hospital</time_frame>
    <description>The proportion of patients with one or more self-reported falls post hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of participants</measure>
    <time_frame>At 30-days post hospital discharge</time_frame>
    <description>Quality of life as measured by EQ5D-5L and reported based on reported Canadian time trade-off values (from 0-1 with higher equal to better quality of life)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Death post hospital discharge</measure>
    <time_frame>30-days post hospital discharge</time_frame>
    <description>Proportion of patients who died post-hospital discharge compared between the intervention and control groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Unplanned visits with the healthcare system</measure>
    <time_frame>30-days post hospital discharge</time_frame>
    <description>Proportion of patients with any self-reported unplanned visit with the healthcare system compared between intervention and control (emergency room visits and hospitalizations)</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of medications at 30-days</measure>
    <time_frame>At 30-days post discharge</time_frame>
    <description>Total number of mediations at 30 days (reported as median and interquartile range) compared between intervention and control</description>
  </other_outcome>
  <other_outcome>
    <measure>Sensitivity analysis for adverse drug events</measure>
    <time_frame>At 30-days post hospital discharge</time_frame>
    <description>Proportion of participants with 1 or more adverse drug events as defined by 4 or more on the 6-point Leape and Bates Likert scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of potentially inappropriate medications that remained stopped</measure>
    <time_frame>30-days post hospital discharge</time_frame>
    <description>Proportion of potentially inappropriate medications that remained stopped between intervention and control</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6582</enrollment>
  <condition>Adverse Drug Event</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants in the control arm will receive medication reconciliation at admission and discharge, and identical follow up, but no prioritized deprescribing list will be generated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will be electronically screened using an electronic software &quot;MedSafer&quot; which will generate output of PIMs that will be brought to the attention of the CTU team via the unit pharmacist as &quot;deprescribing opportunities&quot;. (Note that in the case of multiple recommendations, they will be limited and prioritized so as to avoid overwhelming the treating team.) Based on their own expert medical judgement, in collaboration with the patient/caregiver and other relevant clinicians, a decision will be made to deprescribe if appropriate by the patient's in-hospital doctors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deprescribing opportunities</intervention_name>
    <description>An electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 65 years and older&#xD;
&#xD;
          -  patients who take five or more medications in the community&#xD;
&#xD;
          -  patients who are cognitively impaired or otherwise unable to provide consent will&#xD;
             still be included as this subpopulation of patients may be at greatest risk of ADEs&#xD;
             because of their communication problems.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who take four or fewer medications in the community&#xD;
&#xD;
          -  patients expected to die within 30 days or be transferred to a palliative care&#xD;
             unit/another hospital&#xD;
&#xD;
          -  patients without provincial health insurance or who normally live outside that&#xD;
             province&#xD;
&#xD;
          -  patients previously enrolled&#xD;
&#xD;
          -  inability for patient or proxy to speak English or French&#xD;
&#xD;
          -  no means of contacting patient or proxy post-discharge&#xD;
&#xD;
        Patients discharged from non-study units will be excluded unless that unit is a&#xD;
        transitional care, rehabilitation, or post-acute care unit which bridges the gap between&#xD;
        acute medical hospitalization and community services.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd C Lee, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Centre, Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta, Edmonton</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia, St-Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network, Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Emily McDonald</investigator_full_name>
    <investigator_title>Dr. Emily McDonald, Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Adverse Drug Event</keyword>
  <keyword>Choosing Wisely Canada</keyword>
  <keyword>Deprescribing</keyword>
  <keyword>Elderly</keyword>
  <keyword>Frailty</keyword>
  <keyword>High value healthcare</keyword>
  <keyword>Medication rationalization</keyword>
  <keyword>Medication stewardship</keyword>
  <keyword>Polypharmacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will keep a coded, completely anonymized, database that will be made available to other researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Eighteen (18) months following the study completion.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272607
org study id: MedSafer
secondary id: CIHR Application No. 365795
nct id: NCT03272607
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Reducing medications and associated side effects in older adults: an electronic
      hospital-based intervention
Polypharmacy, or the concomitant use of 5 drugs or more, is a serious health concern and
      affects more than half of Canadians aged 65 years and older. It is the number one
      identifiable risk factor for adverse drug events (ADEs), which are responsible for 27,000
      hospital admissions annually in Canada and up to 20% of return visits to the hospital within
      30 days of discharge. Many ADEs are preventable or ameliorable through interventions to
      reduce inappropriate prescribing.

      MedSafer, the intervention software, applies an electronic set of criteria, previously
      designed and piloted on one thousand (1000) hospitalized patients by a group of Quebec and
      Ontario internists, geriatricians, palliative care doctors and pharmacists, to identify
      potentially inappropriate medications (PIMs) in the hospitalized elderly and generate
      instructions for the patient and physician for safe discontinuation. The current study seeks
      to partially automate the deprescribing process and to demonstrate the efficacy of this type
      of intervention on adverse drug events at 30-days post hospital discharge.

      At the time of hospitalization, the patient's medications, co-morbidities, and a measure of
      frailty will be entered into the MedSafer software which will output an individualized and
      prioritized deprescription plan for the most responsible physician's consideration. Any
      subsequent medication changes will be transmitted to relevant community physicians. The study
      will evaluate the impact of stopping PIMs on the occurrence of ADEs within 30 days of
      discharge, as compared to usual care.

      This study will take place on the clinical teaching units (CTUs) at 11 hospitals from seven
      university hospital centres across Canada. Based on historical data, the investigators
      estimate a combined 5200 eligible patients per year with nearly 50% taking ten or more
      medications. Many will have multiple medical co-morbidities such as diabetes, heart disease,
      and renal insufficiency. A large portion will meet criteria for geriatric syndromes such as
      frailty and will be at high risk for the development of delirium, falls and functional
      decline. This population is ideal for a generalizable deprescribing study.

      All patients aged 65 or older who meet inclusion/exclusion criteria will be enrolled. A
      trained research assistant will identify eligible patients and medications will be screened
      using MedSafer. A deprescribing plan will be generated for the CTU team containing the
      rationale for suggested medication changes and strategies for safe and successful
      deprescription. The CTU team will then decide, in conjunction with the patient/proxy and
      relevant consultants, whether to apply the suggested modifications.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: The duration of the project will be a total of (approx.) 96 weeks. This is a stepped wedge cluster randomized trial study design (see PDF attachment entitled "MedSafer, Figure 1" - note start date will be August 2017 not July 2016). The intervention component will be administered sequentially to six (6) clusters (by city). A randomly selected single cluster will move from control data collection to intervention data collection every 200 patients or roughly every 12 weeks (96 total weeks), which will be followed by 12 weeks to complete follow up and another 36 to analyze data.
Please see PDF attachment entitled "MedSafer, Figure 2" which refers to both parts of the study (quality improvement and follow up components). It describes the follow up component of the study (a 30-day telephone follow-up to ascertain adverse drug events- please note the gray-shaded boxes refer to the Quality Improvement Project-Part 1).
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Medical chart abstracts compiled at discharge (including any subsequent visits within 30 days) will be combined with the patient telephone interview into a case summary report which will be reviewed independently by two trained and blinded clinician reviewers who will be made up of pharmacists and physicians from each study site (but who will not adjudicate any patients from their own site).
measure: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
time frame: Interview performed 30-35 days post-discharge.
description: Post-discharge telephone interview performed by trained personnel using a modification of the Australian two-step adverse reaction and drug event report.
Two trained and blinded clinician reviewers will independently use the Leape and Bates approach to assess whether an ADE was present (yes/no) and if so what was the nature of the injury resulting from it using a four-point Likert scale (definitely preventable, probably preventable, probably not preventable, and definitely not preventable), and assess the probability that an event was attributable to a specific drug that was newly started, changed or continued during hospitalization. In cases of disagreement, a third trained and blinded clinician will review and determine the final assessment.
measure: Number of potentially inappropriate medications
time frame: At hospital discharge and at 30-days post hospital discharge
description: The absolute number of potentially inappropriate medications at discharge among patients who were identified as having a potentially inappropriate medication at admission and for who a deprescribing opportunity was generated and presented to the treating team
measure: Mortality within 30-days post discharge
time frame: 30-days post hospital discharge
description: Death following hospital discharge
measure: Proportion of participants with one or more potentially inappropriate medications deprescribed
time frame: At hospital discharge
description: Proportion of participants with one or more potentially inappropriate medications deprescribed at discharge between intervention and control
measure: Quality of sleep
time frame: 30 days post hospital discharge
description: Quality of sleep measured by the PROMIS Sleep Disturbance 4a measured pre- and post-hospitalization compared between intervention and control
measure: Adverse events
time frame: 30 days post hospital discharge
description: The proportion of patients who had one or more adverse events (falls, hospitalization, death, unplanned encounter with the healthcare system
measure: Falls post hospital discharge
time frame: 30 days post hospital
description: The proportion of patients with one or more self-reported falls post hospital discharge
measure: Quality of life of participants
time frame: At 30-days post hospital discharge
description: Quality of life as measured by EQ5D-5L and reported based on reported Canadian time trade-off values (from 0-1 with higher equal to better quality of life)
measure: Death post hospital discharge
time frame: 30-days post hospital discharge
description: Proportion of patients who died post-hospital discharge compared between the intervention and control groups
measure: Unplanned visits with the healthcare system
time frame: 30-days post hospital discharge
description: Proportion of patients with any self-reported unplanned visit with the healthcare system compared between intervention and control (emergency room visits and hospitalizations)
measure: Total number of medications at 30-days
time frame: At 30-days post discharge
description: Total number of mediations at 30 days (reported as median and interquartile range) compared between intervention and control
measure: Sensitivity analysis for adverse drug events
time frame: At 30-days post hospital discharge
description: Proportion of participants with 1 or more adverse drug events as defined by 4 or more on the 6-point Leape and Bates Likert scale
measure: Proportion of potentially inappropriate medications that remained stopped
time frame: 30-days post hospital discharge
description: Proportion of potentially inappropriate medications that remained stopped between intervention and control
arm group label: Control
arm group type: No Intervention
description: All participants in the control arm will receive medication reconciliation at admission and discharge, and identical follow up, but no prioritized deprescribing list will be generated.
arm group label: Intervention
arm group type: Experimental
description: Participants in the intervention arm will be electronically screened using an electronic software "MedSafer" which will generate output of PIMs that will be brought to the attention of the CTU team via the unit pharmacist as "deprescribing opportunities". (Note that in the case of multiple recommendations, they will be limited and prioritized so as to avoid overwhelming the treating team.) Based on their own expert medical judgement, in collaboration with the patient/caregiver and other relevant clinicians, a decision will be made to deprescribe if appropriate by the patient's in-hospital doctors.
intervention type: Other
intervention name: Deprescribing opportunities
description: An electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration.
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Todd C Lee, MD, MPH
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Emily McDonald
investigator title: Dr. Emily McDonald, Assistant Professor of Medicine
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: Yes
ipd description: We will keep a coded, completely anonymized, database that will be made available to other researchers upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Eighteen (18) months following the study completion.