Clinical trial NCT04961762: Navigator Program for Homeless Adults
Official title: Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Homeless Persons
Case Management
Primary Care
Hospital Readmission
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-07-14
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Follow-Up with Primary Care Provider (PCP)
timeFrame: Within 14 Days of Discharge
Secondary outcomes:
measure: Composite All-Cause Hospital Readmission or Mortality
timeFrame: Within 30, 90, and 180 Days of Discharge
measure: Number of Days in Hospital
timeFrame: Within 30, 90, and 180 Days of Discharge
measure: Number of Emergency Department Visits
timeFrame: Within 30, 90, and 180 Days of Discharge
measure: Self-Reported Experience of Care Transition
timeFrame: At 30-Day Follow-Up Interview
measure: Change in Competing Priorities
timeFrame: Baseline and At 30-Day Follow-Up Interview
measure: Change in Health Status
timeFrame: Baseline and At 30-Day Follow-Up Interview
Other outcomes:
measure: Leave Against Medical Advice
timeFrame: During Index Admission
measure: Medication Adherence
timeFrame: At 30-Day Follow-Up Interview
measure: Connection to Case Manager
timeFrame: At 30-Day Follow-Up Interview
measure: Attendance of non-PCP Health Care Appointment
timeFrame: Within 180 Days of Discharge
measure: Time to Composite All-Cause Hospital Readmission or Mortality
timeFrame: Within 180 Days of Discharge
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Stephen W Hwang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: