Evaluation of an Intimate Partner Violence Screening-Intervention

NCT ID: NCT00257296

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-01
• Study Completion Date: 2005-10-15

Brief Summary

The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV) screening/intervention targeting abused women who are seen for prenatal care in obstetrics-gynecology clinics or general medical care in internal medicine clinics. The intervention is based on our clinical experience and review of the literature which suggests: 1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually occurs over time and not necessarily immediately after it is first detected; 3) women have gone down many different paths leading to an abusive relationship and there is no single path to recovery; 4) for screening/interventions to be credible and ultimately disseminated they must respond to the complexity of the patient stories clinicians see everyday when caring for women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to effectively screen and treat women experiencing IPV unless they are supported by other personnel trained to address IPV as well.

The intervention also is based on recommendations of IPV experts and on the theory of chronic disease management that recognizes that the best outcomes are achieved when: 1) patients are educated and given the support and skills to set their own goals and make their own choices; 2) multidisciplinary teams work better than programs focused only on physician behavior; 3) active monitoring of progress is essential; 4) active coping styles using a range of therapeutic modalities are available and 5) a stepped approach is utilized with those not making progress or with more severe problems receiving the greatest intensity of services.

The screening/intervention will be available to each abused woman for approximately three to six months. Patients in the evaluation study will be surveyed at the following time points: baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early, 9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as a referent group.

Our primary hypotheses are, that compared to usual care, abused women receiving the intervention will have a reduction in levels of IPV, decreases in depression and nonspecific physical symptoms, increase in functional health status, increase in safety behaviors, increase in help seeking for issues related to IPV, and reduction of general medical services.

Conditions

Domestic Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening and Intervention

Use a computer-based screening tool for intimate partner violence and provide a multi-faceted intervention based on the needs of the woman and services should would like to utilize.

Group Type: EXPERIMENTAL

Screening and Intervention

Intervention Type: OTHER

Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient

Usual Care

Use a computer-based screening tool for intimate partner violence and provide list of resources available. Also, all physicians were trained on intimate partner violence and were told they could help anyone regardless of randomization.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Screening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm.

Interventions

Screening and Intervention

Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient

Intervention Type: OTHER

Usual Care

Screening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Females Ages 18 to 45 years Seen at study sites for primary care during study periods Speaks English Able to separate from accompanying person(s) Willing to participant

Exclusion Criteria

Too ill to participate Unable to separate from accompanying person(s) Unable to speak English Refuse to participant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University at Albany

OTHER

Sponsor Role: lead

Responsible Party

Louise-Anne McNutt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise-Anne McNutt, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Albany, State University of New York

Daniel Ford, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

S1751

Identifier Type: -

Identifier Source: org_study_id