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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Mental Health; Emotional Distress
• Intervention / Treatment: Other: System Navigator; Other: Tailored list of resources

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew D Pinto, MD, MSc; Phone Number: 77350 416-864-6060; Email: andrew.pinto@utoronto.ca
• Study Contact Backup: Name: Rose Wang, MPH; Phone Number: 76223 416-864-6060; Email: rose.wang@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Andrew D Pinto, MD MSc; Phone Number: 77350 416-864-6060; Email: andrew.pinto@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Distress on the PROMIS-29 Profile c2.1 Scale	Measure of emotional distress as measured by anxiety and depression systems	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social needs met	Number of social needs experienced by patients from a list (yes/no) at baseline and 3 month follow up	3 months
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
Mortality related to COVID-19 and all cause mortality	Mortality (number of deaths) data obtained from administrative data source	12 months
Number of hospitalizations related to COVID-19 and all cause mortality	hospitalization (number of hospitalizations) data obtained from administrative data source	12 months

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; primary health care; Social Determinants of Health; proactive care
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SMH 20-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No