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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite All-Cause Hospital Readmission or Mortality | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Leave Against Medical Advice | Ascertained from discharge chart review | During Index Admission |
| Connection to Case Manager | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen W Hwang, MD, MPH | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36517099 | Derived | 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. |
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Participants will not have consented to allow for IPD to be shared with other researchers outside of the present day.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2021 | Oct 28, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2025 | Jul 29, 2025 | SAP_005.pdf |
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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.
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Research staff who conduct 30-day follow-up interview with participant are masked to participant's assignment
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| Within 30, 90, and 180 Days of Discharge |
| Number of Emergency Department Visits | Number of emergency department visits will be ascertained from the 30-day interview and administrative databases at ICES. | Within 30, 90, and 180 Days of Discharge |
| At 30-Day Follow-Up Interview |
| Attendance of non-PCP Health Care Appointment | 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. | Within 180 Days of Discharge |
| Self-Reported Experience of Care Transition | 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:
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. | At 30-Day Follow-Up Interview |
| Number of Days in Hospital | 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.) | Within 30, 90, and 180 Days of Discharge |
| Change in Health Status | 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. | Baseline and At 30-Day Follow-Up Interview |
| Change in Competing Priorities | 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. | Baseline and At 30-Day Follow-Up Interview |
| Time to Composite All-Cause Hospital Readmission or Mortality | 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. | Within 180 Days of Discharge |