Navigator Program for Homeless Adults

Primary Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961762
• Other study ID #: 21-058
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Unity Health Toronto
• Contact: Katherine F Pridham, MSW
• Phone: 416-864-6060
• Email: Katherine.Francombe[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Case Management
• Homeless Persons
• Hospital Readmission
• Primary Care

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Unity Health Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Leave Against Medical Advice	Ascertained from discharge chart review	During Index Admission
Other	Medication Adherence	Ascertained with the Morisky Medication Adherence Scale 8 (MMAS-8). The MMAS-8 consists of 8 items, the first 7 of which are yes/no questions, and the last of which is a 5-point Likert-scale rating. Total MMAS-8 scores can range from 0 to 8 and have been categorized into three levels of adherence: high adherence (score = 8), medium adherence (score of 6 to 8), and low adherence (score< 6).	At 30-Day Follow-Up Interview
Other	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.	At 30-Day Follow-Up Interview
Other	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
Other	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
Primary	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 both participant self-report at the 30-day interview and by contact with the PCP office. Ascertainment will be based on the PCP office's report if the participant is unreachable, or by participant self-report if the PCP office is unreachable. In the event of any discrepancy, the report of the PCP office will take precedence over participant self-report.	Within 14 Days of Discharge
Secondary	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.)	Within 30, 90, and 180 Days of Discharge
Secondary	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
Secondary	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
Secondary	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: 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.	At 30-Day Follow-Up Interview
Secondary	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
Secondary	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