Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05823805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '9 months', 'description': 'We will assess health-related quality of life using the World Health Organization WHO QOL-BREF scale'}], 'secondaryOutcomes': [{'measure': 'Preventive care activities and chronic disease management outcomes', 'timeFrame': '9 months', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary health care', 'primary care', 'schizophrenia', 'bipolar disorder', 'cluster randomized controlled trial', 'community health worker', 'randomized controlled trial'], 'conditions': ['Schizophrenia', 'Bipolar Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://upstreamlab.org/project/aftermath/', 'label': 'AFTERMATH study website'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA. 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).\n\nB. 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).\n\nExclusion Criteria:\n\nA. Family Physicians: None\n\nB. Patients: Patients under 18"}, 'identificationModule': {'nctId': 'NCT05823805', 'acronym': 'AFTERMATH', 'briefTitle': 'Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH): Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AFTERMATH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Health Worker + Quality Improvement reports', '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.", 'interventionNames': ['Other: Community Health Worker']}, {'type': 'NO_INTERVENTION', 'label': 'Quality Improvement dashboard', '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."}], 'interventions': [{'name': 'Community Health Worker', 'type': 'OTHER', '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").', 'armGroupLabels': ['Community Health Worker + Quality Improvement reports']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Danial Behzad, BSc', 'role': 'CONTACT', 'email': 'danial.behzad@unityhealth.to', 'phone': '416-864-6060', 'phoneExt': '71307'}, {'name': 'Andrew Pinto, MD MSc', 'role': 'CONTACT', 'email': 'andrew.pinto@utoronto.ca', 'phone': '416-864-6060', 'phoneExt': '76148'}], 'overallOfficials': [{'name': 'Andrew Pinto, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'ipdSharingStatementModule': {'url': 'https://upstreamlab.org/project/aftermath/', 'timeFrame': 'Requests to access the data can be made beginning 3 months and up until 2 years after article publication.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}