Skip to main content
OpenTrials
Completed

NCT Number: NCT04961762

Navigator Program for Homeless Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Follow-Up with Primary Care Provider (PCP)

    Time frame: 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 outcomes

  1. Composite All-Cause Hospital Readmission or Mortality

    Time frame: 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.)

  2. Number of Emergency Department Visits

    Time frame: 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.

Other outcomes

  1. Leave Against Medical Advice

    Time frame: During Index Admission

    Ascertained from discharge chart review

  2. Connection to Case Manager

    Time frame: At 30-Day Follow-Up Interview

    Connection to a case manager after hospital discharge will be assessed only among participants who report no contact with a case manager in the 30 days prior to their baseline interview.

  3. Attendance of non-PCP Health Care Appointment

    Time frame: Within 180 Days of Discharge

    Non-PCP health care appointments are defined as appointments with any medical specialist or health care provider other than the participant's family physician or nurse practitioner. Only appointments documented in the discharge summary will be assessed for attendance. Attendance will be ascertained by contacting the health care provider.

  4. Self-Reported Experience of Care Transition

    Time frame: At 30-Day Follow-Up Interview

    Ascertained with the Care Transitions Measure-3 (CTM-3). The CTM-3 is an abbreviated version of the original CTM-15, which measures the extent to which the healthcare team accomplished essential care processes in preparing the patient for discharge and participating in post-hospital self-care activities.

    The CTM-3 consists of 3 items with a 4-point scale with responses ranging from "Strongly Disagree" (1) to "Strongly Agree" (4) to the following questions:

    • During this hospital stay, staff took my preferences into account in deciding what my healthcare needs would be when I left.
    • When I left the hospital, I had a good understanding of the things I was responsible for in managing my health.
    • When I left the hospital, I clearly understood the purpose for taking each of my medications

    Items are scored by summing the responses and then linear transforming to a 0-100 range. Higher scores indicate better self-reported experience of care transition.

  5. Number of Days in Hospital

    Time frame: Within 30, 90, and 180 Days of Discharge

    Number of days in hospital will be ascertained from the 30-day interview and administrative databases at ICES. (Days in hospital exclude elective or scheduled admissions and labor and delivery visits.)

  6. Change in Health Status

    Time frame: Baseline and At 30-Day Follow-Up Interview

    Ascertained with the EQ-5D-3L (EuroQol-5 Dimensions-3 Levels). The EQ-5D-3L is a generic measure of health-related quality of life that has been widely used among the homeless population. The EQ-5D-3L includes five 3-level items concerning mobility, self-care, usual activities, pain/discomfort, and anxiety/depression that are weighted to produce a single utility score between 0 and 1. The Visual Analog Scale (VAS) of the EQ-5D-3L will also be included, which will allow participants to rate their overall health, mental health, and physical health from 0 to 100.

  7. Change in Competing Priorities

    Time frame: Baseline and At 30-Day Follow-Up Interview

    Ascertained with the RAND Course of Homelessness Scale. Developed specifically for the homeless population, the RAND scale is a 5-item index of self-reported difficulty in meeting the following subsistence needs over the past 30 days: frequency of difficulty in finding shelter, enough to eat, clothing, a place to wash, and a place to use the bathroom. Possible responses to each item are never (1), rarely (2), sometimes (3), or usually (4) with total scores between 5-20. Higher scores indicate more difficulty in meeting subsistence needs.

  8. Time to Composite All-Cause Hospital Readmission or Mortality

    Time frame: Within 180 Days of Discharge

    Time to all-cause hospital readmission or mortality is defined as the number of days from hospital discharge to the first all-cause hospital readmission or mortality during the 180-day observation period.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.