HomelessnessNCT07209072
Emergency Department Linkage to Care for Patients Experiencing Homelessness
A study testing Street medicine follow up in people with Homelessness, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
In an effort to improve access to primary care at time of discharge, patients who are homeless will be given either enhanced follow up through a street medicine team or routine follow up in clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness
- What is being tested?
- Street medicine follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adult (≥18 years of age) DHMC ED patient,
- currently unsheltered, defined as living on the streets, in a vehicle, or in another place not fit for human habitation,
- anticipating ED discharge, with
- a diagnosis listed below that requires short-term follow up:
- COPD or asthma exacerbation
- Bacterial or viral pneumonia
Show all 18Show fewer
- CHF with volume overload
- SSTI
- Dehydration requiring IV fluids
- Hyperglycemia secondary to DM
- Frostbite
- First- and second-degree burns
- Bacterial ENT infections
- Diabetic foot infection
- Traumatic head injury
- Pregnancy
- Opioid overdose
- a stable location (i.e., an intersection, landmark, or encampment where they can be located by the street medicine team) within Denver County for at least 2 weeks.
Who cannot join
- have altered mentation (e.g., intoxication, or secondary to medical, psychiatric, or behavioral conditions) that are unable to communicate their location, contact information, or agree to follow up.
- are prisoners,
- previously enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carolynn Lyle, PAC MPH contact
United States1 site, 1 recruiting
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Kathleen Joseph, MD MPH, 3036020396, kathleen.joseph@dhha.org
Carolynn Lyle, PA-C MPH, carol.lyle@dhha.org
About this study
In an effort to improve access to primary care at time of discharge, patients who are homeless will be given either enhanced follow up through a street medicine team or routine follow up in clinic.
Read the detailed description
Patients who experience homelessness frequently utilize the ED, but lack follow up primary care. In an effort to augment access to post-ED primary care, the investigators propose a quasi-experimental equivalent time sample study in which patients fitting certain diagnostic and inclusion criteria are allocated to either a) a referral to the Comprehensive Care Clinic at Denver Health, or b) a referral to Colorado Coalition for the Homeless (CCH) Stout Street medicine clinic. The street medicine clinic aims to lower barriers to access by locating patients on the street and providing primary care rather than asking patients to present to clinic. All patients will still receive the hospital appointment line number at time of discharge. 1 month and 3 months after index visit, the investigators will examine follow up rates at both clinics as well as secondary outcomes including ED visits, hospitalizations, and mortality through chart review of Denver Health and CCH electronic health records and CORHIO.
- Conditions
- Homelessness
- Being tested
- Street medicine follow up
- Keywords
- primary care, emergency department, homelessness
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Street medicine follow upBehavioural
This intervention will use electronic health record builds to automatically send a referral to a street medicine clinic, who will attempt to contact the patient within 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients will receive a referral to a rapid follow up clinic at time of discharge |
| Street medicine | Experimental | Patients will receive a referral to street medicine at time of discharge Receives: Behavioral: Street medicine follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED visits
Repeat visits to the ED
Measured: 1 and 3 months
Secondary outcomes (2)
Inpatient hospitalizations
Inpatient hospitalizations at this same hospital
Measured: 1 and 3 months
Mortality
Death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start5 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HomelessnessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KJoseph, Denver Health and Hospital Authority
- Investigators
- Jason Haukoos, MD MSc, Study director, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209072
- Sponsor's protocol ID
- COMIRB 24-1764
- Other IDs
- F32HS030344
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to share IPD. Sharing of data will be considered on a case by case basis and only de-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Linkage to Care for Patients Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT07209072
- Acronym / sponsor ID
- COMIRB 24-1764
- Conditions
- Homelessness
- Keywords
- primary care, emergency department, homelessness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
In an effort to improve access to primary care at time of discharge, patients who are homeless will be given either enhanced follow up through a street medicine team or routine follow up in clinic.
Detailed description
Patients who experience homelessness frequently utilize the ED, but lack follow up primary care. In an effort to augment access to post-ED primary care, the investigators propose a quasi-experimental equivalent time sample study in which patients fitting certain diagnostic and inclusion criteria are allocated to either a) a referral to the Comprehensive Care Clinic at Denver Health, or b) a referral to Colorado Coalition for the Homeless (CCH) Stout Street medicine clinic. The street medicine clinic aims to lower barriers to access by locating patients on the street and providing primary care rather than asking patients to present to clinic. All patients will still receive the hospital appointment line number at time of discharge. 1 month and 3 months after index visit, the investigators will examine follow up rates at both clinics as well as secondary outcomes including ED visits, hospitalizations, and mortality through chart review of Denver Health and CCH electronic health records and CORHIO.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients will receive a referral to a rapid follow up clinic at time of discharge |
| Street medicine | Experimental | Behavioral: Street medicine follow upPatients will receive a referral to street medicine at time of discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- adult (≥18 years of age) DHMC ED patient,
- currently unsheltered, defined as living on the streets, in a vehicle, or in another place not fit for human habitation,
- anticipating ED discharge, with
- a diagnosis listed below that requires short-term follow up:
- a stable location (i.e., an intersection, landmark, or encampment where they can be located by the street medicine team) within Denver County for at least 2 weeks.
Key exclusion criteria (3 listed)
- have altered mentation (e.g., intoxication, or secondary to medical, psychiatric, or behavioral conditions) that are unable to communicate their location, contact information, or agree to follow up.
- are prisoners,
- previously enrolled.
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 |
|---|---|---|
| Street medicine follow upThis intervention will use electronic health record builds to automatically send a referral to a street medicine clinic, who will attempt to contact the patient within 2 weeks. | Behavioural | Street medicine |
Primary outcome
ED visits
Time frame: 1 and 3 months
Repeat visits to the ED
2 secondary outcomes
Inpatient hospitalizations
Time frame: 1 and 3 months
Mortality
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. At this time there is no plan to share IPD. Sharing of data will be considered on a case by case basis and only de-identified data will be shared.
Related trials for Homelessness
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Colorectal Cancer Screening in the Homeless
Colorectal Cancer
Not yet recruiting
Community-based Outreach and Navigation for Nurse-led Engagement in HIV Care and Treatment
HIV Infections, HIV Prevention
Not yet recruiting
Homeless Overdose Prevention- Expansion
Homelessness, Opioid Education and Naloxone Distribution (OEND)
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.
Carolynn Lyle, PAC MPH contact
Jason Haukoos, MD MSc study director
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Street medicine follow up in people with Homelessness, run by Denver Health and Hospital Authority at 1 site in United States.
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 18 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen M Joseph, MD MPH (13175194468, kathleen.joseph@dhha.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED visits (time frame: 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.