Evaluating a Digital Toolkit for IPV
2026年5月14日 更新者：Medical University of South Carolina
A Stepped-Wedge Randomized Controlled Trial Evaluating a Digital Toolkit for IPV
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.
研究概览
研究类型
介入性
注册 (估计的)
792
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ariel Worley, MPH
- 电话号码：(843) 792-8208
- 邮箱：worleyar@musc.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion criteria for all participants:
- Age 18 and older
- Able to understand and sign a consent form in English
Inclusion criteria for OTPs:
- Current experience working in one of the three opioid treatment clinics serving as a recruitment site for this study
- Health care professional training (e.g., social worker, counselor, physician, psychologist, nurse practitioner)
Exclusion criteria for OTPs:
- None
Inclusion criteria for patients with OUD:
- Report opioids as their primary substance of use for which they are seeking treatment
- Receive treatment at one of the three opioid treatment clinics serving as a recruitment site for this study
Exclusion criteria for patients with OUD:
- An acute medical problem requiring inpatient treatment (e.g., detoxification)
- Incarceration at the time of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Treatment as Usual
Treatment as usual consists of screening and care practices as usual, as provided by the clinic setting
|
|
|
实验性的：Digital Toolkit
Digital toolkit used for screening and providing referral/treatment planning information for intimate partner violence and mental health conditions
|
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
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients who receive screening
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of providers completing intimate partner violence and mental health screening
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
大体时间：From enrollment until the end of study participation at (up to) 35 months
|
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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Amber M Jarnecke, PhD、Medical University of South Carolina
- 首席研究员：Tanya C Saraiya, PhD、Medical University of South Carolina
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2030年8月1日
研究完成 (估计的)
2030年8月1日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年5月14日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月14日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro00151072
- 1R61DA061371 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
IPD 共享时间框架
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.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.