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

Quality of Life Clinical Trial

— ANTICIPATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197608
• Other study ID #: SMH 20-140
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Unity Health Toronto
• Contact: Andrew D Pinto, MD, MSc
• Phone: 416-864-6060
• Email: andrew.pinto[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Emotional Distress
• Mental Health
• Quality of Life

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
Unity Health Toronto	Barrie and Community Family Health Team, Markham Family Health Team, Ontario Medical Association, Ontario Ministry of Health and Long Term Care, Platinum Medical Clinic, University of Toronto Practice Based Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional Distress on the PROMIS-29 Profile c2.1 Scale	Measure of emotional distress as measured by anxiety and depression systems	3 months
Secondary	Social needs met	Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up	3 months
Secondary	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
Secondary	Mortality related to COVID-19 and all cause mortality	Mortality (number of deaths) data obtained from administrative data source	12 months
Secondary	Number of hospitalizations related to COVID-19 and all cause mortality	hospitalization (number of hospitalizations) data obtained from administrative data source	12 months