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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61DA061371 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The study evaluates a web-based digital toolkit designed to screen for intimate partner violence (IPV), post-traumatic stress disorder (PTSD), and related mental health concerns within opioid treatment programs. Providers use the toolkit during routine care with patients receiving treatment for opioid use disorder. The study examines how the toolkit is implemented into clinic workflows and whether its use improves detection, referral, and patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | No Intervention | Treatment as usual consists of screening and care practices as usual, as provided by the clinic setting | |
| Digital Toolkit | Experimental | Digital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Toolkit | Other | The digital toolkit intervention consists of validated tools to screen patients for intimate partner violence and mental health conditions and evidence-based suggestions for personalized treatment plans and/or referrals |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who receive screening | Proportion of patients seen who receive intimate partner violence and mental health screening | From enrollment until the end of study participation at (up to) 35 months |
| Proportion of patients screened positive for intimate partner violence | Proportion of patients screened who screen positive for intimate partner violence | From enrollment until the end of study participation at (up to) 35 months |
| Proportion of intimate partner violence-positive patients who receive recommended or referred services | Proportion of patients screened positive for intimate partner violence who received recommended or referred services for intimate partner violence | From enrollment until the end of study participation at (up to) 35 months |
| Proportion of patients retained on MOUD following intimate partner violence and mental health screening | Proportion of patients retained in MOUD services for at least 18 months following intimate partner violence and mental health screening | From enrollment until the end of study participation at (up to) 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of providers completing intimate partner violence and mental health screening | Proportion of providers completing intimate partner violence and mental health screening with at least 70% of eligible patients | From enrollment until the end of study participation at (up to) 35 months |
| Proportion of providers providing resources and referrals for patients who screened positive for intimate partner violence |
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Inclusion criteria for all participants:
Inclusion criteria for OTPs:
Exclusion criteria for OTPs:
- None
Inclusion criteria for patients with OUD:
Exclusion criteria for patients with OUD:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel Worley, MPH | Contact | (843) 792-8208 | worleyar@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amber M Jarnecke, PhD | Medical University of South Carolina | Principal Investigator |
| Tanya C Saraiya, PhD | Medical University of South Carolina | Principal Investigator |
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Demographic, survey, and clinical data will be acquired. The raw interview, survey, and clinical data will be stored within a secure computing environment. All direct identifiers will be removed and maintained in a secure file. All other scientific data (coded interview data, scale composites, recodes) will be both preserved and shared via ICPSR. Documentation to be made available will include a study protocol, reference to study publication of primary outcomes, data sets, case report forms, a data dictionary, and study-specific notes. Variables in the data dictionary will include a description, variable name, variable label, and standard codes for missing values.
The first batch of data will be deposited 6 months after enrollment of the first participants and data will be deposited every 6 months thereafter until study completion. The research community will have access to the full data set approximately 18 months following the end of the randomized clinical trial or after the primary paper has been accepted for publication, whichever happens first.
Data will be findable for the research community through ICPSR. For all publications, an ICPSR study will be created and assigned a digital object identifier (DOI). The DOI will be referenced in the publication to allow the research community to access the data used.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000092862 | Psychological Well-Being |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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This study uses a stepped-wedge cluster randomized trial design. Opioid treatment program sites are randomized to transition from treatment as usual to the digital screening toolkit at staggered time intervals until all sites have implemented the intervention.
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Proportion of providers who provided resources and/or referrals for patients who screened positive for intimate partner violence |
| From enrollment until the end of study participation at (up to) 35 months |
| Proportion of providers who had patients accept referrals and/or attempted to attend recommended psychosocial services | Proportion of providers for whom at least 60% of patients accepted referrals and/or attempted to attend recommended psychosocial services | From enrollment until the end of study participation at (up to) 35 months |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |