Navigator Program for Homeless Adults

NCT ID: NCT04961762

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2025-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Navigator Program

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 Type: EXPERIMENTAL

Navigator Program

Intervention Type: 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.

Standard Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Navigator Program

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen W Hwang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36517099 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

21-058

Identifier Type: -

Identifier Source: org_study_id