St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
NCT Number: NCT04961762
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5B1W8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.)
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.
Time frame: During Index Admission
Ascertained from discharge chart review
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.
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.
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:
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.
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.)
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.
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.
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.
Unity Health Toronto
Other
Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial
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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.
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