At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care

Study Overview
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Brief Summary
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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.

Official Title
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At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care (ANTICIPATE): a Pragmatic Randomized Controlled Trial

Conditions
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Emotional Distress, Quality of Life, Mental Health

Intervention / Treatment
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* Other: System Navigator
* Other: Tailored list of resources


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of: chronic condition (diabetes, CHF, CAD, COPD or asthma) serious mental illness (schizophrenia or bipolar disorder) anticipated to live in poverty and/or be homeless/underhoused Exclusion Criteria: patients unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - System Navigator<br>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. Working with the System Navigator will mean: Discussing patients' current health status and concerns Receiving support on management of chronic diseases and mental health including connection to local resources e.g. counseling, harm reduction, crisis support services Receiving information about benefits that they may be entitled to and learning about free services Receiving help from the System Navigator on forms or letters that are required to access resources | Other: System Navigator<br>* 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.<br>|
| Active Comparator: Tailored list of community resources<br>Control group will be provided a tailored list of community resources. | Other: Tailored list of resources<br>* Control group will be provided a tailored list of resources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Distress on the PROMIS-29 Profile c2.1 Scale | Measure of emotional distress as measured by anxiety and depression systems | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social needs met | Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up | 3 months | 
| 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 | 
| Mortality related to COVID-19 and all cause mortality | Mortality (number of deaths) data obtained from administrative data source | 12 months | 
| Number of hospitalizations related to COVID-19 and all cause mortality | hospitalization (number of hospitalizations) data obtained from administrative data source | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Determinants of Health, COVID-19, primary health care, proactive care