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临床试验/NCT03259646
NCT03259646已完成不适用

The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women

Johns Hopkins University17 个研究点 分布在 1 个国家目标入组 6,272 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,272
试验地点
17
主要终点
Change in Self-Efficacy to Use Harm Reduction Strategies

研究概览

简要总结

Violence against women is a major public health threat that carries significant consequences for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual assault (SA) are more likely than non-abused women to seek certain forms of health services, such as for sexually transmitted infections, chronic pain and illnesses, depression and/or pregnancy-related concerns. As a result, the health sector is an ideal setting to identify and support survivors. The U.S. Institute of Medicine has identified the health care system, including the public health infrastructure, as key for identification of and support for survivors of violence, as well as for violence prevention. While some evidence-based models exist, no current national consensus has been reached on scalable best practices in screening and brief counseling for IPV/SA.

This multi-level intervention includes integrating into the clinic setting IPV/SA screening, universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy, health and safety outcomes, as well as participant and provider perceptions of the intervention and clinic level changes in primary and reproductive health clinics in four states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following aims:

Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA programs compared to standard practice, on survivor health and safety outcomes over a cumulative period of six months.

Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA programs and improved standards for documentation through the electronic health record (EHR) and continuous quality measurement and reporting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Seeking healthcare at one of 14 partner clinics
  • Ability to complete a survey on a device (computer/tablet/smartphone in English or Spanish)
  • Access to safe device (as defined above) if doing surveys online
  • Has a safe email address or safe phone number
  • Is not acutely ill

排除标准

  • Not seeking healthcare at one of 9 partner clinics
  • Younger than 18 years of age
  • Older than 59 years of age
  • Cannot read/speak English or Spanish
  • No access to safe device if doing surveys online
  • Does not have a safe email address or safe phone number
  • Acutely ill

结局指标

主要结局

Change in Self-Efficacy to Use Harm Reduction Strategies

时间窗: 6 months

Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.

Change in use of safety behaviors

时间窗: 6 months

Measured by percent of safety behaviors the woman has tried and found helpful on the Safety Behaviors Checklist. The checklist was adapted from Sullivan and colleagues and Parker and colleagues. Includes use of community resources and safety steps (e.g. asked for help, hidden emergency money) and use of formal services (e.g., women's shelter, protection order, mental health services).

Provider Behavior

时间窗: Baseline

Clinic level measure. Provider Behavior at Visit Survey items administered after the provider visit to assess the provider's adherence to universal education intervention, i.e. discussing healthy and unhealthy relationships during the visit, and referring to resources.

次要结局

  • Change in Readiness to Take Action(6 months)
  • Change in decisional conflict(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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