NCT05823805

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
10mo left

Started Sep 2025

Shorter than P25 for not_applicable schizophrenia

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

April 19, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

April 19, 2023

Last Update Submit

August 11, 2025

Conditions

Keywords

primary health careprimary careschizophreniabipolar disordercluster randomized controlled trialcommunity health workerrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • health-related quality of life

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

    9 months

Secondary Outcomes (1)

  • Preventive care activities and chronic disease management outcomes

    9 months

Study Arms (2)

Community Health Worker + Quality Improvement reports

EXPERIMENTAL

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.

Other: Community Health Worker

Quality Improvement dashboard

NO INTERVENTION

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.

Interventions

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").

Community Health Worker + Quality Improvement reports

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. Family physicians: Any family physician in a University of Toronto DFCM academic site with 10+ community-dwelling patients living with 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 schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's).

You may not qualify if:

  • A. Family Physicians: None
  • B. Patients: Patients under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Andrew Pinto, MD MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Pinto, MD MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 21, 2023

Study Start

September 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data from this study will be made available to qualified researchers with academic interest in primary care health equity research and mental health research. Data will only be made available to interested parties after all applicable agreements have been executed.

Time Frame
Requests to access the data can be made beginning 3 months and up until 2 years after article publication.
Access Criteria
Access to study IPD will be granted to qualified researchers upon approval of their Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). To submit a request or for any additional questions, please contact Upstreamlab@unityhealth.to.
More information