Housing ProblemsNCT03864341
ED-Home Pilot Study
A study testing Referral to homelessness prevention services, Substance use services and Follow-up in people with Housing Problems and Drug Use, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the Bellevue Hospital emergency department (ED). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Housing Problems, Drug Use, Alcohol; Use, Problem
- What is being tested?
- Referral to homelessness prevention services, Substance use services and Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a patient in the Bellevue Hospital Center ED.
- Be ≥18 years old.
- Screen positive for homelessness risk using a homelessness risk screening tool (HRST).
- Screen positive for unhealthy alcohol or drug use.
- Able to provide consent.
Who cannot join
- Medically (e.g., critically ill) or psychiatrically unstable.
- Unable to provide informed consent for other reason (e.g., cognitive deficit, profound intoxication).
- Incarcerated or in police custody.
- Unable to understand and speak English.
- Lives outside NYC and/or cannot give a NYC ZIP code.
- Already homeless (residing in a shelter or on the streets).
Show all 9Show fewer
- Does not have a telephone where can be reached for follow-up.
- Has already received specialized peer navigator/addiction social worker services during current ED visit.
- Has already participated in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: ED-Home: A Pilot Feasibility Study of a Homelessness Prevention Intervention for Substance Using Emergency Department Patients
This is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the Bellevue Hospital emergency department (ED). ED patients (n=40) found eligible for the study will complete a baseline assessment and receive referrals to appropriate services, with a final six-month follow-up assessment.
Read the detailed description
ED patients found eligible for the study will complete a baseline survey and receive one-time, in person services at the time of the baseline/enrollment ED visit including referrals to homelessness prevention and substance use services, with a final six-month follow-up survey. Interim contacts at 7-10 days, 3 months, and 5 months will be used to assure intervention components were received and to confirm participant contact information.
- Conditions
- Housing Problems, Drug Use, Alcohol; Use, Problem
- Being tested
- Referral to homelessness prevention services, Substance use services, Follow-up
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to homelessness prevention servicesBehavioural
Referral to Homebase homelessness prevention services offered by community-based organizations in NYC
Substance use servicesBehavioural
Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital
Follow-upBehavioural
Follow-up to assist participants in receiving homelessness prevention services
| Study group | Role | What they receive |
|---|---|---|
| Homelessness Prevention Services | Experimental | Not described Receives: Behavioral: Referral to homelessness prevention services; Behavioral: Substance use services; Behavioral: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Potential Participants Approached Who Were Eligible for the Study
Measured: Month 6
Percentage of Eligible Participants Who Agreed to Participate in the Study
Measured: Month 6
Number of Participants Who Received Referrals for Homelessness Prevention and/or Substance Use Services
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start8 May 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Housing ProblemsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Doran, MD, MHS, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864341
- Sponsor's protocol ID
- 18-02040
- Other IDs
- K23DA039179
- Status last verified
- Jul 2022
- First submitted
- 4 Mar 2019
- Last updated
- 19 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED-Home: A Pilot Feasibility Study of a Homelessness Prevention Intervention for Substance Using Emergency Department Patients
- ClinicalTrials.gov ID
- NCT03864341
- Acronym / sponsor ID
- 18-02040
- Conditions
- Housing Problems, Drug Use, Alcohol; Use, Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the Bellevue Hospital emergency department (ED). ED patients (n=40) found eligible for the study will complete a baseline assessment and receive referrals to appropriate services, with a final six-month follow-up assessment.
Detailed description
ED patients found eligible for the study will complete a baseline survey and receive one-time, in person services at the time of the baseline/enrollment ED visit including referrals to homelessness prevention and substance use services, with a final six-month follow-up survey. Interim contacts at 7-10 days, 3 months, and 5 months will be used to assure intervention components were received and to confirm participant contact information.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homelessness Prevention Services | Experimental | Behavioral: Referral to homelessness prevention services, Behavioral: Substance use services, Behavioral: Follow-up |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a patient in the Bellevue Hospital Center ED.
- Be ≥18 years old.
- Screen positive for homelessness risk using a homelessness risk screening tool (HRST).
- Screen positive for unhealthy alcohol or drug use.
- Able to provide consent.
Key exclusion criteria (9 listed)
- Medically (e.g., critically ill) or psychiatrically unstable.
- Unable to provide informed consent for other reason (e.g., cognitive deficit, profound intoxication).
- Incarcerated or in police custody.
- Unable to understand and speak English.
- Lives outside NYC and/or cannot give a NYC ZIP code.
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 |
|---|---|---|
| Referral to homelessness prevention servicesReferral to Homebase homelessness prevention services offered by community-based organizations in NYC | Behavioural | Homelessness Prevention Services |
| Substance use servicesReferral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital | Behavioural | Homelessness Prevention Services |
| Follow-upFollow-up to assist participants in receiving homelessness prevention services | Behavioural | Homelessness Prevention Services |
Primary outcome
Percentage of Potential Participants Approached Who Were Eligible for the Study
Time frame: Month 6
Percentage of Eligible Participants Who Agreed to Participate in the Study
Time frame: Month 6
Number of Participants Who Received Referrals for Homelessness Prevention and/or Substance Use Services
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Housing Problems
Recruiting
Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness
Opioid Use Disorder, Dual Diagnosis
Recruiting
Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis
Opioid Use Disorder, Alcohol Use Disorder
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.
Kelly Doran, MD, MHS principal investigator
New York Langone 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 Referral to homelessness prevention services, Substance use services and Follow-up in people with Housing Problems and Drug Use, run by NYU Langone Health 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 5 inclusion and 9 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 19 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Potential Participants Approached Who Were Eligible for the Study (time frame: Month 6). The study lists 3 primary outcomes in all. 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 19 Aug 2022.