Navigator Program for Homeless Adults

Not Applicable

Active, not recruiting

• Conditions: Homeless Persons; Case Management; Hospital Readmission; Primary Care

• Registration Number: NCT04961762
• Lead Sponsor: Unity Health Toronto

Brief Summary

Individuals experiencing homelessness often have complex health and social needs. This population also faces disproportionate systemic barriers to accessing health care services and social supports, such as not having primary care providers, needing to meet other competing priorities, and difficulties affording medications. These barriers contribute to discontinuities in care, poor health outcomes, and high acute healthcare utilization after hospitalization among this population. This randomized controlled trial aims to evaluate the effect of a case management intervention (the Navigator program) for individuals experiencing homelessness who have been admitted to hospital for medical conditions. This study will examine outcomes over a 180-day period after hospital discharge, including follow-up with primary care providers, acute healthcare utilization, quality of care transitions, and overall health.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-07-03
• Study First Posted: 2021-07-14
• Study Start: 2021-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-07-29
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 656

Inclusion Criteria

• 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
• Identified as being homeless at the time of admission or anytime during the index hospital admission. This includes patients who are: unsheltered (absolutely homeless and living on the streets or in places not intended for human habitation), emergency sheltered (staying in overnight shelters for people who are homeless, as well as shelters for those impacted by family violence), or provisionally accommodated (whose accommodation is temporary or lacks security of tenure).

Exclusion Criteria

• Unable to provide informed consent to the study
• Previously received services from the Homeless Outreach Counsellor within 90 days of admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Follow-Up with Primary Care Provider (PCP)	Within 14 Days of Discharge	Occurrence of a follow-up visit with a PCP (family physician or nurse practitioner). In-person encounters (e.g., ambulatory clinics, shelter clinics, and community health centers), virtual encounters (with video), and phone calls (without video) will be considered as follow-up visits. These modes of PCP follow-up are consistent with those outlined by quality standards from Health Quality Ontario. The investigators will ascertain PCP follow-up through: 1) participant self-report at the 30-day interview, 2) PCP office confirmation, and 3) administrative databases (OHIP and Community Health Center Databases at ICES).; PCP follow-up documented in any of the three data sources will be considered sufficient to meet the primary outcome criterion.

Secondary Outcome Measures

Name	Time	Method
Composite All-Cause Hospital Readmission or Mortality	Within 30, 90, and 180 Days of Discharge	Hospital readmissions will be ascertained from the 30-day interview and administrative databases at ICES. Mortality data will be collected from hospital charts, follow-up with community contacts, or administrative databases at ICES. (Hospital readmissions exclude elective or scheduled admissions, labor and delivery visits, and transfers between services \[i.e., from medicine to psychiatry\] within the hospital.)
Number of Emergency Department Visits	Within 30, 90, and 180 Days of Discharge	Number of emergency department visits will be ascertained from the 30-day interview and administrative databases at ICES.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada