Homeless PersonsNCT04961762
Navigator Program for Homeless Adults
A study testing Navigator Program in people with Homeless Persons and Case Management, run by Unity Health Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homeless Persons, Case Management, Primary Care
- What is being tested?
- Navigator Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2021to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Unable to provide informed consent to the study
- Previously received services from the Homeless Outreach Counsellor within 90 days of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial
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.
- Conditions
- Homeless Persons, Case Management, Primary Care, Hospital Readmission
- Being tested
- Navigator Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Navigator Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 Days of Discharge
Secondary outcomes (2)
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.)
Measured: 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.
Measured: Within 30, 90, and 180 Days of Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start18 Oct 2021
- Primary completion3 Mar 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Stephen W Hwang, MD, MPH, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961762
- Sponsor's protocol ID
- 21-058
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will not have consented to allow for IPD to be shared with other researchers outside of the present day.
Publications
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.
PubMed 36517099
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04961762
- Acronym / sponsor ID
- 21-058
- Conditions
- Homeless Persons, Case Management, Primary Care, Hospital Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Navigator Program | Experimental | Other: Navigator ProgramIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Unable to provide informed consent to the study
- Previously received services from the Homeless Outreach Counsellor within 90 days of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator ProgramThe 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. | Other | Navigator Program |
Primary outcome
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.
2 secondary outcomes
Composite All-Cause Hospital Readmission or Mortality
Time frame: Within 30, 90, and 180 Days of Discharge
Number of Emergency Department Visits
Time frame: Within 30, 90, and 180 Days of Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 36517099Liu 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.
- Individual participant dataSharing planned: No. Participants will not have consented to allow for IPD to be shared with other researchers outside of the present day.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen W Hwang, MD, MPH principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator Program in people with Homeless Persons and Case Management, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-Up with Primary Care Provider (PCP) (time frame: Within 14 Days of Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.