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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05197608
Other study ID # SMH 20-140
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2022
Est. completion date March 2024

Study information

Verified date November 2023
Source Unity Health Toronto
Contact Andrew D Pinto, MD, MSc
Phone 416-864-6060
Email andrew.pinto@utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care. Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date March 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of: 1. chronic condition (diabetes, CHF, CAD, COPD or asthma) 2. serious mental illness (schizophrenia or bipolar disorder) 3. anticipated to live in poverty and/or be homeless/underhoused Exclusion Criteria: - patients unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
System Navigator
Participants will be connected to a System Navigator, who is a trained staff embedded within their primary health clinic to support and help navigate biological, psychological and social needs in proactively identified vulnerable patients.
Tailored list of resources
Control group will be provided a tailored list of resources

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (7)

Lead Sponsor Collaborator
Unity Health Toronto Barrie and Community Family Health Team, Markham Family Health Team, Ontario Medical Association, Ontario Ministry of Health and Long Term Care, Platinum Medical Clinic, University of Toronto Practice Based Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotional Distress on the PROMIS-29 Profile c2.1 Scale Measure of emotional distress as measured by anxiety and depression systems 3 months
Secondary Social needs met Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up 3 months
Secondary COVID related outcomes (patient-reported questionnaire built for this study) Patient-reported COVID-related clinic or hospitalization visits and COVID vaccine status captured at baseline and 3 month follow up 3 months
Secondary Mortality related to COVID-19 and all cause mortality Mortality (number of deaths) data obtained from administrative data source 12 months
Secondary Number of hospitalizations related to COVID-19 and all cause mortality hospitalization (number of hospitalizations) data obtained from administrative data source 12 months
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