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

Not Applicable

Recruiting

• Conditions: Emotional Distress; Quality of Life; Mental Health
• Interventions: Other: System Navigator; Other: Tailored list of resources

• Registration Number: NCT05197608
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-19
• Study Start: 2022-02-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - System Navigator	System Navigator	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
Tailored list of community resources	Tailored list of resources	Control group will be provided a tailored list of community resources.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada