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Clinical Trials/NCT03259646
NCT03259646CompletedNot Applicable

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

Johns Hopkins University9 sites in 1 country6,272 target enrollmentStarted: May 26, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6,272
Locations
9
Primary Endpoint
Change in Self-Efficacy to Use Harm Reduction Strategies

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 59 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Universal Education

Experimental

Train providers to integrate screening, universal education, trauma informed counseling, and mobile health (mHealth) technology through the myPlan app safety decision aid in collaboration with local IPV programs as well as the integration of documentation and quality improvement templates and measures into clinical settings.

Intervention: Universal Education (Behavioral)

Standard Practice

No Intervention

Standard clinical practice

Outcomes

Primary Outcomes

Change in Self-Efficacy to Use Harm Reduction Strategies

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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