search
Back to results

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

Primary Purpose

Emotional Distress, Quality of Life, Mental Health

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
System Navigator
Tailored list of resources
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emotional Distress focused on measuring Social Determinants of Health, COVID-19, primary health care, proactive care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention - System Navigator

Tailored list of community resources

Arm Description

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

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

Outcomes

Primary Outcome Measures

Emotional Distress
Measure of emotional distress as measured by anxiety and depression systems.

Secondary Outcome Measures

Social needs met
Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up
COVID related outcomes
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
Mortality and hospitalization data obtained from administrative data source

Full Information

First Posted
September 27, 2021
Last Updated
January 14, 2022
Sponsor
Unity Health Toronto
Collaborators
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05197608
Brief Title
At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Quality of Life, Mental Health
Keywords
Social Determinants of Health, COVID-19, primary health care, proactive care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention - System Navigator
Arm Type
Experimental
Arm Description
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
Arm Title
Tailored list of community resources
Arm Type
Active Comparator
Arm Description
Control group will be provided a tailored list of community resources.
Intervention Type
Other
Intervention Name(s)
System Navigator
Intervention Description
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 Type
Other
Intervention Name(s)
Tailored list of resources
Intervention Description
Control group will be provided a tailored list of resources
Primary Outcome Measure Information:
Title
Emotional Distress
Description
Measure of emotional distress as measured by anxiety and depression systems.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Social needs met
Description
Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up
Time Frame
3 months
Title
COVID related outcomes
Description
Patient reported COVID related clinic or hospitalization visits captured at baseline and 3 month follow up
Time Frame
3 months
Title
Mortality and hospitalizations related to COVID-19 and all cause mortality
Description
Mortality and hospitalization data obtained from administrative data source
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew D Pinto, MD, MSc
Phone
416-864-6060
Ext
77350
Email
andrew.pinto@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Wang, MPH
Phone
416-864-6060
Ext
76223
Email
rose.wang@unityhealth.to
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs