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

Sponsor

Unity Health Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05197608

Collaborator

Ontario Ministry of Health and Long Term Care (Other), Ontario Medical Association (Other), Platinum Medical Clinic (Other), Markham Family Health Team (Other), Barrie and Community Family Health Team (Other), University of Toronto Practice Based Research Network (Other)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Distress Quality of Life Mental Health	Other: System Navigator Other: Tailored list of resources	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	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.
Active Comparator: Tailored list of community resources Control group will be provided a tailored list of community resources.	Other: Tailored list of resources Control group will be provided a tailored list of resources

Arm

Intervention/Treatment

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

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.

Active Comparator: Tailored list of community resources

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

Other: Tailored list of resources

Control group will be provided a tailored list of resources

Outcome Measures

Primary Outcome Measures

Emotional Distress [3 months]
Measure of emotional distress as measured by anxiety and depression systems.

Secondary Outcome Measures

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 [3 months]
Patient reported COVID related clinic or hospitalization visits captured at baseline and 3 month follow up
Mortality and hospitalizations related to COVID-19 and all cause mortality [12 months]
Mortality and hospitalization data obtained from administrative data source

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B1W8

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT05197608

Other Study ID Numbers:

SMH 20-140

First Posted:

Jan 19, 2022

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Unity Health Toronto

Social Determinants of Health

COVID-19

primary health care

proactive care

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 19, 2022