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Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH) (AFTERMATH)

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Health Worker
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring primary health care, primary care, schizophrenia, bipolar disorder, cluster randomized controlled trial, community health worker, randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria: A. Family Physicians: Any family physician in the University of Toronto Practice-Based Research Network (UTOPIAN) with 10+ community-dwelling patients living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's). B. Patients: Patients from the included family physician practices living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's). Exclusion Criteria: A. Family Physicians: None B. Patients: Patients under 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Community Health Worker + Quality Improvement reports

    Quality Improvement dashboard

    Arm Description

    Family physicians with ten or more patients living with schizophrenia and/or bipolar disorder will work with a community health worker who will assist them in reviewing their individualized reports, which presents data on patient's preventive health care status and engagement in care.

    Family physicians with ten or more patients living with schizophrenia and/or bipolar disorder will have access to an individualized reports, which presents data on patient's preventive health care status and engagement in care.

    Outcomes

    Primary Outcome Measures

    health-related quality of life
    We will assess health-related quality of life using the World Health Organization WHO QOL-BREF scale

    Secondary Outcome Measures

    preventive care activities
    We will assess the number of up-to-date preventive care activities

    Full Information

    First Posted
    April 19, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05823805
    Brief Title
    Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)
    Acronym
    AFTERMATH
    Official Title
    Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH): Cluster Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Unity Health Toronto

    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
    The COVID-19 pandemic significantly impacted primary care across Canada. Inequities in prevention activities and chronic disease management likely increased but the extent is unknown. Pragmatic interventions are required to prioritize patients and improve the quality of primary care post-COVID. In AFTERMATH, the investigators will conduct a pragmatic cluster randomized controlled trial (cRCT) at the largest primary care Practice-Based Research Network (PBRN) in Ontario, focused on a highly marginalized population: adults living with mental illness and one or more additional chronic diseases. The investigators will test an intervention that builds on the investigators' past work and combines data and supports to primary care providers to improve quality of life, reduce gaps in prevention activities and improve chronic disease management. The investigators' project will result in new evidence on ways to improve access to care and reduce inequities, and inform future efforts to use data beyond COVID-19.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Bipolar Disorder
    Keywords
    primary health care, primary care, schizophrenia, bipolar disorder, cluster randomized controlled trial, community health worker, randomized controlled trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Community Health Worker + Quality Improvement reports
    Arm Type
    Experimental
    Arm Description
    Family physicians with ten or more patients living with schizophrenia and/or bipolar disorder will work with a community health worker who will assist them in reviewing their individualized reports, which presents data on patient's preventive health care status and engagement in care.
    Arm Title
    Quality Improvement dashboard
    Arm Type
    No Intervention
    Arm Description
    Family physicians with ten or more patients living with schizophrenia and/or bipolar disorder will have access to an individualized reports, which presents data on patient's preventive health care status and engagement in care.
    Intervention Type
    Other
    Intervention Name(s)
    Community Health Worker
    Intervention Description
    Physicians will work with a Community Health Worker (CHW) to review the data presented in their Quality Improvement reports, and triage patients for proactive outreach (e.g. "No action necessary", "Call patient to check-in", "Arrange BP, weight and labs", "Book for phone appointment", "Book for in-person appointment").
    Primary Outcome Measure Information:
    Title
    health-related quality of life
    Description
    We will assess health-related quality of life using the World Health Organization WHO QOL-BREF scale
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    preventive care activities
    Description
    We will assess the number of up-to-date preventive care activities
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A. Family Physicians: Any family physician in the University of Toronto Practice-Based Research Network (UTOPIAN) with 10+ community-dwelling patients living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's). B. Patients: Patients from the included family physician practices living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's). Exclusion Criteria: A. Family Physicians: None B. Patients: Patients under 18
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Cassano, BA
    Phone
    416-864-6060
    Ext
    40218
    Email
    antonio.cassano@unityhealth.to
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Pinto, MD MSc
    Phone
    416-864-6060
    Ext
    76148
    Email
    andrew.pinto@utoronto.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing URL
    https://upstreamlab.org/project/aftermath/
    Links:
    URL
    https://upstreamlab.org/project/aftermath/
    Description
    Related Info

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