Clinical trial NCT05197608: At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care
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
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Distress
Quality of Life
Mental Health
Keywords: Social Determinants of Health
COVID-19
primary health care
proactive care
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Ontario Medical Association
name: Platinum Medical Clinic
name: Markham Family Health Team
name: Barrie and Community Family Health Team
name: University of Toronto Practice Based Research Network
First posted: 2022-01-19
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Emotional Distress on the PROMIS-29 Profile c2.1 Scale
timeFrame: 3 months
Secondary outcomes:
measure: Social needs met
timeFrame: 3 months
measure: COVID related outcomes (patient-reported questionnaire built for this study)
timeFrame: 3 months
measure: Mortality related to COVID-19 and all cause mortality
timeFrame: 12 months
measure: Number of hospitalizations related to COVID-19 and all cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: