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

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 Overview

• Status: Completed
• Conditions: Violence, Domestic; Violence, Sexual
• Intervention / Treatment: Behavioral: Universal Education

• Study Type: Interventional
• Enrollment (Actual): 6272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Kingman, Arizona, United States, 86401
      • North County HealthCare
    • Lake Havasu City, Arizona, United States, 86403
      • North Country HealthCare
    • Williams, Arizona, United States, 86046
      • North Country HealthCare
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Partners Health Care Brigham and Women's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital of UPMC
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • Women's Health Center
    • Mill Creek, West Virginia, United States, 26280
      • Valley Health
    • Ronceverte, West Virginia, United States, 24970
      • Greenbrier Co. Health Dept
    • Scott Depot, West Virginia, United States, 25560
      • FamilyCare Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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:

• Male
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Universal Education; 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.	Behavioral: Universal Education; Clinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings.
NO_INTERVENTION: Standard Practice; Standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in use of safety behaviors	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).	6 months
Change in Self-Efficacy to Use Harm Reduction Strategies	Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.	6 months
Provider Behavior	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in decisional conflict	We have adapted questions from validated subscales of the Decisional Conflict Scale as a measure of decision process. Measures whether the intervention helps a woman to understand the advantages and disadvantages of safety planning options and to know her values related to them. The Decisional Conflict Scale discriminates between people who make decisions and those who delay making decisions.	6 months
Change in Readiness to Take Action	0-10 scale of readiness to make changes to relationship for safety	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of Pittsburgh; Office of Research on Women's Health (ORWH); Futures Without Violence
• Investigators: Principal Investigator: Nancy Glass, PhD, MPH, RN, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2017
• Primary Completion (ACTUAL): April 25, 2019
• Study Completion (ACTUAL): April 25, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00090497; 6 ASTWH150032-01 (OTHER_GRANT: Office of Women's Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No