Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT05197608

Conditions

Emotional Distress

Quality of Life

Mental Health

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

System Navigator

Tailored list of resources

Study Details

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

Study ID

NCT05197608

Start date

Feb 25, 2022

Status verified date

Nov, 2023

Completion date

Mar, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention - 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

active comparator: Tailored list of community resources

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

Interventions

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

Primary outcome measure

  • Emotional Distress on the PROMIS-29 Profile c2.1 Scale [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Andrew D Pinto, MD, MSc

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

Rose Wang, MPH

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

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Andrew D Pinto, MD MSc

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

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 4, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2023-12-04.