Social Work Assistance and Stipends for Housing (SASH) (SASH)
Primary Purpose
Opioid-Related Disorders, Housing Problems
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stipend and Social Work Supports
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders
Eligibility Criteria
Inclusion Criteria: Experienced homelessness during at least 15 of the 30 days preceding enrollment Is a patient at the University of Maryland Addiction Treatment Program (ATP) receiving methadone treatment. Exclusion Criteria: -
Sites / Locations
- University of Maryland Addiction Treatment Program (ATP)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm
Arm Description
Individuals will receive $500 monthly stipend for the first months of the study and will receive twelve months of social work supports to help individuals find permanent housing.
Outcomes
Primary Outcome Measures
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
OUD Checklist scores
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
OUD Checklist scores
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
OUD Checklist scores
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Urine toxicology tests
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Number of Days Homeless
Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)
Number of Days Homeless
Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)
Secondary Outcome Measures
Full Information
NCT ID
NCT05803603
First Posted
March 23, 2023
Last Updated
April 4, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05803603
Brief Title
Social Work Assistance and Stipends for Housing (SASH)
Acronym
SASH
Official Title
Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
SASH is a clinical trial feasibility study that will provide an intervention to improve Opioid Use Disorder (OUD), Quality of Life (QOL), and housing outcomes for homeless patients receiving Medication for Opiate Use Disorder (MOUD). The main questions of the study are does a $500 housing stipend for individuals on MOUD increase treatment retention, improved quality of life and prevent homelessness.
Detailed Description
SASH is a clinical trial feasibility study that will provide an housing stipend for 8 individuals (N=8) experience homelessness and currently being treated for OUD to improve OUD treatment outcomes, QOL, and housing outcomes. To achieve these goals, patients will receive monthly $500 housing stipends that can be used for a broad range of temporary housing included in a list of resources compiled by the study. These stipends will be accompanied by Social Work assistance to find permanent housing which will last the full 12 months of the study. SASH will recruit OUD patients receiving MOUD who are struggling with homelessness, defined as living in an emergency shelter or a place not meant for habitation instead of a fixed, regular, and adequate nighttime residence. This definition is consistent with the one used by the U.S. Department of Housing and Urban Development. The patients will be recruited from the University of Maryland Addiction Treatment Program (ATP), a certified Substance Use Disorder (SUD) treatment program that provides MOUD and collocates medical care, wellness programs, and research. Patients will be eligible for SASH if they experienced homelessness during at least 15 of the 30 days preceding the dispensing of the first month's stipends.SASH will accomplish its goals using the following aims and objectives:
AIM 1: Improve OUD outcomes
Hypothesis 1a: Patients will miss fewer methadone doses and receive more take-home methadone doses after receiving the stipends and Social Work assistance Endpoint: Percentages of missed and take-home methadone doses, as recorded by the software tracking methadone-dispensing at the ATP, in the 3-month period before the study, between Month 3 and 6 of the study, and between Month 9 and 12 of the study
Hypothesis 1b: Patients will experience an improvement in their OUD after receiving the stipends and Social Work assistance Endpoint: OUD Checklist scores completed at Day 0, Month 6, and Month 12 of the study
Hypothesis 1c: Patients will use fewer opioids and illicit substances after receiving the stipends and Social Work assistance Endpoint: Monthly urine toxicology tests (UTT) three months before study entry and monthly during the study
AIM 2: Improve QOL
Hypothesis 2a: Patients will experience improvement in QOL during the study Endpoint: SF-36 scores at Day 0, Month 6, and Month 12 of the study
Hypothesis 2b: Patients will report benefit from receiving the stipends and Social Work assistance
AIM 3: Prevent homelessness
Hypothesis 3a: The monthly $500 stipends will prevent patients from being homeless Endpoint: Percentage of days patients are homeless during the 6-month period stipends are distributed
Hypothesis 3b: Patients will be in housing by the end of the study Endpoint: Percentage of patients who are homeless or in either permanent or temporary housing by Month 12 of the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Housing Problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
8 individuals will be recruited and followed for 12 months following the intervention. The intervention includes providing a $500 monthly housing stipend for six months and twelve months of social work support to find permanent housing. Individuals will be asked to provide information thought interviews and clinical records.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Individuals will receive $500 monthly stipend for the first months of the study and will receive twelve months of social work supports to help individuals find permanent housing.
Intervention Type
Behavioral
Intervention Name(s)
Stipend and Social Work Supports
Intervention Description
Same as arm description
Primary Outcome Measure Information:
Title
Methadone Doses
Description
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Time Frame
3 months prior to enrollment
Title
Methadone Doses
Description
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Time Frame
3-6 months post enrollment
Title
Methadone Doses
Description
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Time Frame
9-12 months post enrollment.
Title
OUD Checklist scores
Description
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
Time Frame
Baseline
Title
OUD Checklist scores
Description
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
Time Frame
6 months
Title
OUD Checklist scores
Description
Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.
Time Frame
12 months
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Three months prior to enrollment
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 1
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 2
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 3
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 4
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 5
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 6
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 7
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 8
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 9
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 10
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 11
Title
Urine toxicology tests
Description
Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome
Time Frame
Month 12
Title
Quality of Life Scores
Description
SF-36 scores 0 (worst) to 100 (best)
Time Frame
Baseline
Title
Quality of Life Scores
Description
SF-36 scores 0 (worst) to 100 (best)
Time Frame
6 Month
Title
Quality of Life Scores
Description
SF-36 scores 0 (worst) to 100 (best)
Time Frame
12 Month
Title
Number of Days Homeless
Description
Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)
Time Frame
6 Months
Title
Number of Days Homeless
Description
Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experienced homelessness during at least 15 of the 30 days preceding enrollment
Is a patient at the University of Maryland Addiction Treatment Program (ATP) receiving methadone treatment.
Exclusion Criteria:
-
Facility Information:
Facility Name
University of Maryland Addiction Treatment Program (ATP)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol will be made available to other researchers. Because only a small number of participants are being enrolled (N=8) outcomes data will be limited to what can be share without identifying individuals.
IPD Sharing Time Frame
The data will be available at the end of the study period for 5 years.
IPD Sharing Access Criteria
Access criteria to be determined.
Learn more about this trial
Social Work Assistance and Stipends for Housing (SASH)
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