SchizophreniaAFTERMATHNCT05823805
Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)
A study testing Community Health Worker in people with Schizophrenia and Bipolar Disorder, run by Unity Health Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Community Health Worker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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).
Who cannot join
- Family Physicians: None
- Patients: Patients under 18
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Community Health Worker
- Keywords
- primary health care, primary care, schizophrenia, bipolar disorder, cluster randomized controlled trial, community health worker, randomized controlled trial
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerOther
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").
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related quality of life
We will assess health-related quality of life using the World Health Organization WHO QOL-BREF scale
Measured: 9 months
Secondary outcomes (1)
Preventive care activities and chronic disease management outcomes
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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study startSep 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pinto, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823805
- Sponsor's protocol ID
- AFTERMATH
- Acronym
- AFTERMATH
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH): Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823805
- Acronym / sponsor ID
- AFTERMATH / AFTERMATH
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- primary health care, primary care, schizophrenia, bipolar disorder, cluster randomized controlled trial, community health worker, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker + Quality Improvement reports | Experimental | Other: Community Health WorkerFamily 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
- 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).
Key exclusion criteria (2 listed)
- Family Physicians: None
- Patients: Patients under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health WorkerPhysicians 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"). | Other | Community Health Worker + Quality Improvement reports |
Primary outcome
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
1 secondary outcome
Preventive care activities and chronic disease management outcomes
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- AFTERMATH study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Pinto, MD MSc principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker in people with Schizophrenia and Bipolar Disorder, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danial Behzad, BSc (416-864-6060 ext. 71307, danial.behzad@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health-related quality of life (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.