Navigator Program for Homeless Adults

NCT04961762 | Completed

• 1 other identifier: 21-058
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

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.

Conditions

Homeless Persons; Case Management; Primary Care; Hospital Readmission

Outcome Measures

Primary Outcomes (1)

• Follow-Up with Primary Care Provider (PCP)

  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.

  Within 14 Days of Discharge

Secondary Outcomes (2)

• Composite All-Cause Hospital Readmission or Mortality

  Within 30, 90, and 180 Days of Discharge

• Number of Emergency Department Visits

  Within 30, 90, and 180 Days of Discharge

Other Outcomes (8)

• Leave Against Medical Advice

  During Index Admission

• Connection to Case Manager

  At 30-Day Follow-Up Interview

• Attendance of non-PCP Health Care Appointment

  Within 180 Days of Discharge

Study Arms (2)

Navigator Program

EXPERIMENTAL

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.

Other: Navigator Program

Standard Care

NO 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.

Interventions

Navigator Program OTHER

The main role of the Homeless Outreach Counsellor is to support continuity and comprehensiveness of care by helping participants follow their post-discharge plans and facilitating strong links with community-based health and social services. The Homeless Outreach Counsellor also helps address specific needs of participants, develop comprehensive care plans with members of patient's multidisciplinary circle of care, and facilitate the transition of clients to long-term community-based health and social services.

Navigator Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (1)

• Liu M, Pridham KF, Jenkinson J, Nisenbaum R, Richard L, Pedersen C, Brown R, Virani S, Ellerington F, Ranieri A, Dada O, To M, Fabreau G, McBrien K, Stergiopoulos V, Palepu A, Hwang S. Navigator programme for hospitalised adults experiencing homelessness: protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Dec 14;12(12):e065688. doi: 10.1136/bmjopen-2022-065688.

  PMID: 36517099 DERIVED

Study Officials

• Stephen W Hwang, MD, MPH

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff who conduct 30-day follow-up interview with participant are masked to participant's assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention: specialized homeless-specific case management services starting during hospitalization and continuing for approximately 3 months after discharge. Usual care: treatment as usual, without access to specialized homeless-specific case management services.

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 14, 2021
• Study Start: October 18, 2021
• Primary Completion: March 3, 2025
• Study Completion: August 1, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)