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

NCT ID: NCT03259646

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2019-04-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Universal Education

Intervention Type: 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.

Standard Practice

Standard clinical practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Futures Without Violence

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Glass, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

North County HealthCare

Kingman, Arizona, United States

North Country HealthCare

Lake Havasu City, Arizona, United States

North Country HealthCare

Williams, Arizona, United States

Partners Health Care Brigham and Women's Hospital

Boston, Massachusetts, United States

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Women's Health Center

Charleston, West Virginia, United States

Valley Health

Mill Creek, West Virginia, United States

Greenbrier Co. Health Dept

Ronceverte, West Virginia, United States

FamilyCare Health Center

Scott Depot, West Virginia, United States

Countries

United States

Other Identifiers

6 ASTWH150032-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00090497

Identifier Type: -

Identifier Source: org_study_id