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

August 11, 2025 updated by: Unity Health Toronto

Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH): Cluster Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • 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 Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

A. Family Physicians: None

B. Patients: Patients under 18

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Health Worker + Quality Improvement reports
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
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").
No Intervention: Quality Improvement dashboard
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: 9 months
We will assess health-related quality of life using the World Health Organization WHO QOL-BREF scale
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventive care activities and chronic disease management outcomes
Time Frame: 9 months
Preventive care activities up-to-date and chronic disease management outcomes, which reflect the goals of primary care teams, and health services outcomes (primary care visits, emergency department visits, hospitalizations, and total health services costs).
9 months

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Andrew Pinto, MD MSc, Unity Health Toronto

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.

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 (Estimated)

September 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFTERMATH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Requests to access the data can be made beginning 3 months and up until 2 years after article publication.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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