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Navigator Program for Homeless Adults

N/A
Recruiting
Led By Stephen W Hwang, MD, MPH
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Have an unplanned admission for any medical cause to the General Internal Medicine service, any Medicine subspecialty service, the Cardiac Intensive Care Unit, and the Medical Surgical Intensive Care Unit
Must not have
Unable to provide informed consent to the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during index admission
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the Navigator program, which helps homeless individuals manage their healthcare and social needs after leaving the hospital. It aims to reduce hospital visits and improve overall health over several months.

Who is the study for?
This trial is for adults over 18 who are homeless at the time of an unplanned hospital admission. It includes those without shelter, in emergency shelters, or in temporary housing. Participants must not have used Homeless Outreach services within 90 days and must be able to consent to the study.
What is being tested?
The Navigator Program is being tested as a case management intervention for homeless individuals after hospital discharge. The trial will track follow-up with primary care, re-hospitalization rates, quality of care transitions, and overall health over six months.
What are the potential side effects?
Since this trial involves a social support program rather than medication, there aren't typical medical side effects; however, participants may experience stress or anxiety from changes in their healthcare routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I was unexpectedly admitted to the hospital for a medical reason.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30, 90, and 180 days of discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30, 90, and 180 days of discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Follow-Up with Primary Care Provider (PCP)
Secondary study objectives
Change in Competing Priorities
Change in Health Status
Composite All-Cause Hospital Readmission or Mortality
+3 more
Other study objectives
Attendance of non-PCP Health Care Appointment
Connection to Case Manager
Leave Against Medical Advice
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Navigator ProgramExperimental Treatment1 Intervention
In addition to receiving Standard Care, participants in the intervention arm will be assigned to a Homeless Outreach Counsellor. The Homeless Outreach Counsellor will connect with the participant as soon as possible during the admission and will provide support during the hospital admission and for approximately 90 days after hospital discharge.
Group II: Standard CareActive Control1 Intervention
Standard Care consists of support from Care Transition Facilitators who work with patients during their hospital stay to arrange discharge plans and make follow-up arrangements. Care Transition Facilitators do not routinely work with patients after hospital discharge. As part of the routine discharge process, the health care team provides patients with medical recommendations, appointments for follow-up care as needed, a written discharge summary, and prescriptions as needed. If the patient has an identified primary care provider, a copy of the discharge summary is sent electronically to the primary care provider.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Case management interventions for homelessness, such as those studied in the Navigator Program, typically involve personalized support to help individuals navigate healthcare and social services. These interventions include an initial assessment of needs, development of a tailored care plan, and ongoing support through regular follow-ups. The mechanisms of action involve connecting patients with primary care providers, coordinating medical and social services, and addressing barriers such as lack of transportation or documentation. This approach is crucial for homeless patients as it helps ensure continuity of care, reduces acute healthcare utilization, and improves overall health outcomes by addressing both medical and social determinants of health.
The effectiveness of case management interventions for the homeless, vulnerably housed and persons with lived experience: A systematic review.A multi-site comparison of supported housing for chronically homeless adults: "Housing first" versus "residential treatment first"A systematic review of interventions to increase the uptake of opiate substitution therapy in injecting drug users.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,390 Previous Clinical Trials
26,518,864 Total Patients Enrolled
Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
453,626 Total Patients Enrolled
3 Trials studying Homelessness
92 Patients Enrolled for Homelessness
Stephen W Hwang, MD, MPHPrincipal InvestigatorUnity Health Toronto

Media Library

Navigator Program Clinical Trial Eligibility Overview. Trial Name: NCT04961762 — N/A
Homelessness Research Study Groups: Navigator Program, Standard Care
Homelessness Clinical Trial 2023: Navigator Program Highlights & Side Effects. Trial Name: NCT04961762 — N/A
Navigator Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961762 — N/A
~157 spots leftby Dec 2025