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

NCT03259646 | Completed DMC

• 2 other identifiers: IRB000904976 ASTWH150032-01
• Study Type: interventional
• Target: 6,272
• Locations: 1 country
• Sites: 9

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.

Conditions

Violence, Domestic; Violence, Sexual

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in decisional conflict

  6 months

• Change in Readiness to Take Action

  6 months

Study Arms (2)

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.

Behavioral: Universal Education

Standard Practice

NO INTERVENTION

Standard clinical practice

Interventions

Universal Education BEHAVIORAL

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.

Universal Education

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: Cis-gender or trans-gender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Office of Research on Women's Health (ORWH): collaborator
• University of Pittsburgh: collaborator
• Futures Without Violence: collaborator

Study Sites (9)

North County HealthCare

Kingman, Arizona, 86401, United States

Location

North Country HealthCare

Lake Havasu City, Arizona, 86403, United States

Location

North Country HealthCare

Williams, Arizona, 86046, United States

Location

Partners Health Care Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Women's Health Center

Charleston, West Virginia, 25302, United States

Location

Valley Health

Mill Creek, West Virginia, 26280, United States

Location

Greenbrier Co. Health Dept

Ronceverte, West Virginia, 24970, United States

Location

FamilyCare Health Center

Scott Depot, West Virginia, 25560, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Nancy Glass, PhD, MPH, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized trial

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: May 26, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)