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

Violence, Domestic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259646
• Other study ID #: IRB00090497
• Secondary ID: 6 ASTWH150032-01
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: April 25, 2019

Study information

• Verified date: January 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6272
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Violence, Domestic
• Violence, Sexual

Intervention

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.

Locations

Country	Name	City	State
United States	Partners Health Care Brigham and Women's Hospital	Boston	Massachusetts
United States	Women's Health Center	Charleston	West Virginia
United States	North County HealthCare	Kingman	Arizona
United States	North Country HealthCare	Lake Havasu City	Arizona
United States	Valley Health	Mill Creek	West Virginia
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Greenbrier Co. Health Dept	Ronceverte	West Virginia
United States	FamilyCare Health Center	Scott Depot	West Virginia
United States	North Country HealthCare	Williams	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Futures Without Violence, Office of Research on Women's Health (ORWH), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Change in Readiness to Take Action	0-10 scale of readiness to make changes to relationship for safety	6 months