Emotional Distress, Mental Health, Quality of Life
Conditions
Keywords
Social Determinants of Health, COVID-19, primary health care, proactive care
Brief 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.
Interventions
OTHERSystem 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.
OTHERTailored list of resources
Control group will be provided a tailored list of resources
Sponsors
Ontario Ministry of Health and Long Term Care
Ontario Medical Association
Platinum Medical Clinic
Markham Family Health Team
Barrie and Community Family Health Team
University of Toronto Practice Based Research Network
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants will be randomized into intervention or control group. The intervention group will be connected to a system navigator who is a trained staff member embedded within the primary health clinic team with a focus to address participant's biological, psychological and social needs. Control group will be provided a tailored list of community resources.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Distress on the PROMIS-29 Profile c2.1 Scale | 3 months | Measure of emotional distress as measured by anxiety and depression systems |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social needs met | 3 months | Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up |
| COVID related outcomes (patient-reported questionnaire built for this study) | 3 months | Patient-reported COVID-related clinic or hospitalization visits and COVID vaccine status captured at baseline and 3 month follow up |
| Mortality related to COVID-19 and all cause mortality | 12 months | Mortality (number of deaths) data obtained from administrative data source |
| Number of hospitalizations related to COVID-19 and all cause mortality | 12 months | hospitalization (number of hospitalizations) data obtained from administrative data source |
Countries
Canada
Contacts
Primary ContactAndrew D Pinto, MD, MSc
Backup ContactRose Wang, MPH
Outcome results
None listed