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

NCT05197608 | Unknown

• 1 other identifier: SMH 20-140
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Distress; Quality of Life; Mental Health

Keywords

Social Determinants of Health; COVID-19; primary health care; proactive care

Outcome Measures

Primary Outcomes (1)

• Emotional Distress on the PROMIS-29 Profile c2.1 Scale

  Measure of emotional distress as measured by anxiety and depression systems

  3 months

Secondary Outcomes (4)

• Social needs met

  3 months

• COVID related outcomes (patient-reported questionnaire built for this study)

  3 months

• Mortality related to COVID-19 and all cause mortality

  12 months

• Number of hospitalizations related to COVID-19 and all cause mortality

  12 months

Study Arms (2)

Intervention - System Navigator

EXPERIMENTAL

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

Tailored list of community resources

ACTIVE COMPARATOR

Control group will be provided a tailored list of community resources.

Other: Tailored list of resources

Interventions

System Navigator OTHER

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.

Intervention - System Navigator

Tailored list of resources OTHER

Control group will be provided a tailored list of resources

Tailored list of community resources

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients unable to provide informed consent

Sponsors & Collaborators

• Unity Health Toronto: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Ontario Medical Association: collaborator
• Platinum Medical Clinic: collaborator
• Markham Family Health Team: collaborator
• Barrie and Community Family Health Team: collaborator
• University of Toronto Practice Based Research Network: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; COVID-19

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Andrew D Pinto, MD, MSc

CONTACT

416-864-6060; andrew.pinto@utoronto.ca

Rose Wang, MPH

CONTACT

416-864-6060; rose.wang@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: January 19, 2022
• Study Start: February 25, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)