Social Work Assistance and Stipends for Housing (SASH)

Study Overview
=================
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

Official Title
-----------------
Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder

Conditions
-----------------
Opioid-Related Disorders, Housing Problems

Intervention / Treatment
-----------------
* Behavioral: Stipend and Social Work Supports


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Behavioral: Stipend and Social Work Supports<br>* Same as arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 3 months prior to enrollment | 
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 3-6 months post enrollment | 
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 9-12 months post enrollment. | 
| 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. | Baseline | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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 | Three months prior to enrollment | 
| 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 | Month 1 | 
| 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 | Month 2 | 
| 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 | Month 3 | 
| 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 | Month 4 | 
| 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 | Month 5 | 
| 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 | Month 6 | 
| 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 | Month 7 | 
| 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 | Month 8 | 
| 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 | Month 9 | 
| 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 | Month 10 | 
| 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 | Month 11 | 
| 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 | Month 12 | 
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | Baseline | 
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | 6 Month | 
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | 12 Month | 
| Number of Days Homeless | Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse) | 6 Months | 
| Number of Days Homeless | Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse) | 12 Months |