HomelessnessNCT05823220
A Pragmatic Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
A study testing Homeless diversion (HD) and Treatment-as-usual (TAU) in people with Homelessness, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness
- What is being tested?
- Homeless diversion (HD) and Treatment-as-usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 1 Sep 2025
- 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
- English or Spanish speaking
- discharged from a Harris Health Hospital ED (Ben Taub or LBJ)
- at imminent risk of homelessness
- patients with Medicaid, Medicare or who are uninsured
Who cannot join
- having a conservator (legal guardian)
- plans to move away from Texas in 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Pragmatic Randomized Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
The purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD) services to better meet the needs of diverse communities.
- Conditions
- Homelessness
- Being tested
- Homeless diversion (HD), Treatment-as-usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeless diversion (HD)Behavioural
Participants will receive services from specialty-trained community health workers and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey
Treatment-as-usual (TAU)Behavioural
Participants will receive a list of community resources they can contact to receive services and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey
| Study group | Role | What they receive |
|---|---|---|
| Homeless diversion (HD) group | Experimental | Not described Receives: Behavioral: Homeless diversion (HD) |
| Treatment-as-usual (TAU) group | Active comparator | Not described Receives: Behavioral: Treatment-as-usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ED visits
Measured: end of study (6 months after start of study)
Secondary outcomes (2)
Number of participants who experience homelessness
Measured: end of study (6 months after start of study)
Change in health related quality of life as assessed by the Short Form-12 version 2.0 (SF12v2) health Survey
This is a 12 item questionnaire and scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start14 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jack Tsai, The University of Texas Health Science Center, Houston
- Investigators
- Jack Tsai, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823220
- Sponsor's protocol ID
- HSC-SPH-22-0762
- Other IDs
- R01MD018213
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
- ClinicalTrials.gov ID
- NCT05823220
- Acronym / sponsor ID
- HSC-SPH-22-0762
- Conditions
- Homelessness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
The purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD) services to better meet the needs of diverse communities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeless diversion (HD) group | Experimental | Behavioral: Homeless diversion (HD) |
| Treatment-as-usual (TAU) group | Active comparator | Behavioral: Treatment-as-usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- discharged from a Harris Health Hospital ED (Ben Taub or LBJ)
- at imminent risk of homelessness
- patients with Medicaid, Medicare or who are uninsured
Key exclusion criteria (2 listed)
- having a conservator (legal guardian)
- plans to move away from Texas in 6 months
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 |
|---|---|---|
| Homeless diversion (HD)Participants will receive services from specialty-trained community health workers and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey | Behavioural | Homeless diversion (HD) group |
| Treatment-as-usual (TAU)Participants will receive a list of community resources they can contact to receive services and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey | Behavioural | Treatment-as-usual (TAU) group |
Primary outcome
Number of ED visits
Time frame: end of study (6 months after start of study)
2 secondary outcomes
Number of participants who experience homelessness
Time frame: end of study (6 months after start of study)
Change in health related quality of life as assessed by the Short Form-12 version 2.0 (SF12v2) health Survey
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
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 2025.
- Individual participant dataSharing planned: No
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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.
Jack Tsai, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeless diversion (HD) and Treatment-as-usual (TAU) in people with Homelessness, run by The University of Texas Health Science Center, Houston 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 4 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2025. 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?
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?
Number of ED visits (time frame: end of study (6 months after start of study)). 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 2025.