ED-Home Pilot Study

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03864341
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Housing Problems; Drug Use; Alcohol; Use, Problem	Behavioral: Referral to homelessness prevention services; Behavioral: Substance use services; Behavioral: Follow-up	N/A

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

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: ED-Home: A Pilot Feasibility Study of a Homelessness Prevention Intervention for Substance Using Emergency Department Patients
• Actual Study Start Date: May 8, 2019
• Actual Primary Completion Date: Mar 23, 2020
• Actual Study Completion Date: Mar 23, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Homelessness Prevention Services

Behavioral: Referral to homelessness prevention services; Referral to Homebase homelessness prevention services offered by community-based organizations in NYC; Behavioral: Substance use services; Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital; Behavioral: Follow-up; Follow-up to assist participants in receiving homelessness prevention services

Outcome Measures

Primary Outcome Measures

1. Percentage of Potential Participants Approached Who Were Eligible for the Study [Month 6]

2. Percentage of Eligible Participants Who Agreed to Participate in the Study [Month 6]

3. Number of Participants Who Received Referrals for Homelessness Prevention and/or Substance Use Services [Month 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kelly Doran, MD, MHS, New York Langone Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 18, 2020
• Informed Consent Form - Mar 12, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03864341
• Other Study ID Numbers: 18-02040; K23DA039179
• First Posted: Mar 6, 2019
• Last Update Posted: Aug 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

Participant Flow

Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
Period Title: Overall Study
STARTED	40
COMPLETED	39
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
Overall Participants	39
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	44
Sex: Female, Male (Count of Participants)
Female	9 23.1%
Male	30 76.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 46.2%
Not Hispanic or Latino	21 53.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.6%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	19 48.7%
White	6 15.4%
More than one race	1 2.6%
Unknown or Not Reported	12 30.8%
Region of Enrollment (participants) [Number]
United States	39 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Potential Participants Approached Who Were Eligible for the Study
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

This feasibility endpoint is related to the percentage of potential participants approached who were eligible to participate in the study -- since the number of eligible people is greater than those who were enrolled, the total number of "participants" analyzed is greater than what is listed in the participant flow.

Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
Measure Participants	2183
Number [Percentage of Participants]	2.34 6%

2. Primary Outcome

Title	Percentage of Eligible Participants Who Agreed to Participate in the Study
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

This feasibility endpoint is related to the percentage of eligible people who agreed to participate in the study -- since the number of eligible people is greater than those who were enrolled, the total number of "participants" analyzed is greater than what is listed in the participant flow.

Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
Measure Participants	51
Number [Percentage of Participants]	78.43 201.1%

3. Primary Outcome

Title	Number of Participants Who Received Referrals for Homelessness Prevention and/or Substance Use Services
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
Measure Participants	39
Count of Participants [Participants]	39 100%

Adverse Events

Time Frame	6 months
Arm/Group Title	Homelessness Prevention Services
Arm/Group Description	Referral to homelessness prevention services: Referral to Homebase homelessness prevention services offered by community-based organizations in NYC Substance use services: Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital Follow-up: Follow-up to assist participants in receiving homelessness prevention services
All Cause Mortality
	Homelessness Prevention Services
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Homelessness Prevention Services
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Homelessness Prevention Services
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.