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Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions (IMPROVE-IT)

Primary Purpose

Patient Discharge, Drug-Related Side Effects and Adverse Reactions, Aged

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medication Coordinated care
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Discharge focused on measuring Polypharmacy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults over the age of 65 years.
  • Admitted to Medicine or Surgery services for more than 2 days.
  • High cost users (defined as):
  • Have at least one other hospitalization within the previous year.
  • Taking 5 or more chronic medications including at least one TRIIM-Med.
  • Provide informed consent.

Exclusion Criteria:

  • Patients with "do not approach status".
  • Patient or Caregiver not fluent in English.
  • Patients who do not provide informed consent.
  • Patients admitted for < 2 days.
  • Patients < 65 years of age.
  • Not a high cost user (as defined above).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Arm

    Control Arm (Usual care)

    Arm Description

    Clinical Pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists.

    Patients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.

    Outcomes

    Primary Outcome Measures

    Feasibility Outcome: Recruitment rate for eligible patients.
    The main trial will be considered feasible if we are able to recruit at least 50% of eligible patients in this pilot.
    Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.
    The number of TRIIM-Meds successfully deprescribed (dose reduction or discontinued) at 2 months post-hospital discharge, aiming to be able to detect a mean difference of 0.5.

    Secondary Outcome Measures

    Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.
    This will be measured based on the number of successfully enrolled patients, and the number of patients that will entirely undergo the intervention through telemedicine.
    Feasibility Outcomes of patient retention rate.
    This will be measured by looking at the number of patients enrolled, the number of patients that dropped out, and the number of patients that completed the study.
    Feasibility Outcomes of likelihood of the intervention proving cost-effective.
    This will be measured using Healthcare resource utilization questionnaire, which will determine whether the intervention reduced healthcare costs compared to the control group.
    Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.
    This outcome will be measured using the Coordination and Continuity of Care Questionnaire (CCCQ). Which is a questionnaire we adapted from the brief prepared questionnaire (B-PREPARED) and the three-question care transitions measure questionnaire (CTM-3).
    Patient-important outcomes: Health related quality of life: EQ-5D-5L
    This outcome will be measured using the EuroQol five-dimensional, five-level descriptive system (EQ-5D-5L) that asks patients to self-assess their own health quality related quality of life. Whereas a scoring metric is used to assess the overall health related quality of life based on the answers to the questions. The questionnaire scale considers 1 as the best possible health and 5 as the worst health possible.

    Full Information

    First Posted
    August 7, 2019
    Last Updated
    April 10, 2023
    Sponsor
    St. Joseph's Healthcare Hamilton
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04077281
    Brief Title
    Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions
    Acronym
    IMPROVE-IT
    Official Title
    Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions (IMPROVE-IT): A Pilot Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    November 19, 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Medication safety is a crucial health issue for every older Canadian since many of the medications causing serious harm are those which also have life-saving or important symptom-relieving benefits. Very few specialists can accurately advise seniors which medications provide more benefit than harm for them personally, and make changes safely as this requires a very large breadth and depth of knowledge about the patient, the conditions they have and their therapies. Now that telemedicine is compatible with smart phones, this extends the ability of scarce specialists to 'see' any patient in Canada in a way that is more convenient for the patient and may be less expensive than current care. This project will find out whether a unique Clinical Pharmacology specialist team in Hamilton, Ontario can improve medication safety (stop medications no longer needed, reduce doses where appropriate, change to safer medications) for a high risk group of older hospitalized Canadians taking many medications. The hospital where this pilot study will take place was the first to install the world's leading electronic health record and set it up to facilitate and support high quality research. Patients who volunteer will be assigned to their usual care, or to the intervention which is the Clinical Pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists. The investigators will study whether the intervention is effective and cost-effective at reducing harmful medication burden, reducing the need to return to hospital, or improving the patient's ratings of their care coordination. The results will determine whether a subsequent large trial is worthwhile.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient Discharge, Drug-Related Side Effects and Adverse Reactions, Aged, Health Care Costs
    Keywords
    Polypharmacy

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Clinical Pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists.
    Arm Title
    Control Arm (Usual care)
    Arm Type
    No Intervention
    Arm Description
    Patients will receive a best possible medication history (BPMH) as do the intervention patients, then usual care by their primary team.
    Intervention Type
    Other
    Intervention Name(s)
    Medication Coordinated care
    Intervention Description
    Clinical Pharmacology & Toxicology consult CPT team completes detailed circle of care communication Telemedicine followup by CPT team (approximately 48 hrs post-discharge & 1 week to1 month post-discharge)
    Primary Outcome Measure Information:
    Title
    Feasibility Outcome: Recruitment rate for eligible patients.
    Description
    The main trial will be considered feasible if we are able to recruit at least 50% of eligible patients in this pilot.
    Time Frame
    Through the study completion, an average of 2 years
    Title
    Clinical Outcome: The number of TRIIM-Meds successfully deprescribed.
    Description
    The number of TRIIM-Meds successfully deprescribed (dose reduction or discontinued) at 2 months post-hospital discharge, aiming to be able to detect a mean difference of 0.5.
    Time Frame
    2 months post discharge
    Secondary Outcome Measure Information:
    Title
    Feasibility Outcomes of CPT consultation volume capacity and potential to apply the intervention entirely through telemedicine.
    Description
    This will be measured based on the number of successfully enrolled patients, and the number of patients that will entirely undergo the intervention through telemedicine.
    Time Frame
    Through the study completion, an average of 2 years
    Title
    Feasibility Outcomes of patient retention rate.
    Description
    This will be measured by looking at the number of patients enrolled, the number of patients that dropped out, and the number of patients that completed the study.
    Time Frame
    Through the study completion, an average of 2 years
    Title
    Feasibility Outcomes of likelihood of the intervention proving cost-effective.
    Description
    This will be measured using Healthcare resource utilization questionnaire, which will determine whether the intervention reduced healthcare costs compared to the control group.
    Time Frame
    Through the study completion, an average of 2 years
    Title
    Patient-important outcomes: Participant ratings of coordination and continuity of transitions in care.
    Description
    This outcome will be measured using the Coordination and Continuity of Care Questionnaire (CCCQ). Which is a questionnaire we adapted from the brief prepared questionnaire (B-PREPARED) and the three-question care transitions measure questionnaire (CTM-3).
    Time Frame
    2 months post discharge
    Title
    Patient-important outcomes: Health related quality of life: EQ-5D-5L
    Description
    This outcome will be measured using the EuroQol five-dimensional, five-level descriptive system (EQ-5D-5L) that asks patients to self-assess their own health quality related quality of life. Whereas a scoring metric is used to assess the overall health related quality of life based on the answers to the questions. The questionnaire scale considers 1 as the best possible health and 5 as the worst health possible.
    Time Frame
    2 months post discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults over the age of 65 years. Admitted to Medicine or Surgery services for more than 2 days. High cost users (defined as): Have at least one other hospitalization within the previous year. Taking 5 or more chronic medications including at least one TRIIM-Med. Provide informed consent. Exclusion Criteria: Patients with "do not approach status". Patient or Caregiver not fluent in English. Patients who do not provide informed consent. Patients admitted for < 2 days. Patients < 65 years of age. Not a high cost user (as defined above).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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