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Completed

NCT Number: NCT03016481

Realizing Opportunities for Self-Supported Improvement (ROSSI)

This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes Research Institute (PCORI) and will test an adapted priority-based patient navigation versus care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or referred from, University of Rochester Medical Center providers. The goal is to improve patient safety, depression, and health function over the course of 12 months. In the Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested in our first UR PCORI grant, in addition to meeting with a social worker, patients will work with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed over the course of the next 6 months to navigate services and overcome barriers. In addition, patients will receive referrals to other professionals based on their prioritization and meet with the CHW at the time and place of their choice. Patients in the Care as Usual- Social Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for intake and referrals, does a needs assessment, and offers safety planning in referral.

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Key information

Conditions

Domestic Violence Behavior Behavioral Symptoms Depression Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must be English speaking URMC patients, who are 18 years of age or older, and/or the non-offending parent on a CPS report for a URMC pediatrics patient, and who have experienced an IPV or emotional abuse event within the past 3 months.

IPV is defined as endorsing any of the following items:

  • Slapped, kicked, pushed, choked, or punched?
  • Forced or coerced to have sex?
  • Threatened you with a knife or gun to scare or hurt you?
  • Made you feel afraid that you would be physically hurt?
  • Repeatedly used words, yelled, or screamed in a way that frightened you?
  • Threatened you, put you down, or made you feel rejected? Yes No Additional inclusion criteria include depression based on PHQ-9 score of >10.

Exclusion criteria

  • Subjects are ineligible if they have active psychosis or alcohol or substance dependence based on 3 months threshold on the Mini-International Neuropsychiatric Interview (MINI).
  • Additionally, patients who are unable to understand the consent form or study procedures, are imminently suicidal, or are currently working with a CHW will be excluded.

Treatment and study plan

Active Comparator: the Community Health Worker -Personalized Support for Progress

Behavioral

Subjects will meet with their CHW to prioritize their needs detected by the Promote psychosocial screening and identify their preferences for intervention using a secure, online card sorting tool called Optimal Sort. The subject will explain her/his rationale for each decision to the CHW, allowing them both to begin to identify goals. The prioritization survey results provide subjects a personalized package of services that map onto the four main intervention options: legal help, problem solving therapy, medical consultation, or social services.

Other names: CHW-PSP

Care as Usual- Social Worker

Behavioral

Based on their assessment and the subjects' needs, brief onsite interventions are provided and consist of empowerment focused advocacy, IPV education, community referrals, and safety planning. Participants determine follow-up. This will be a short-term interaction as routinely practiced across hospital settings.

Other names: CAU-SW

Primary outcomes

  1. Patient Safety

    Time frame: immediate post intervention (6 months)

    To assess whether CHW-PSP improves patient safety, as compared to CAU-SW Participants will complete the Conflict Tactics Scale-2 a modified from a 20-item self-report measure 10 assessing areas of negotiation, psychological aggression, physical assault, sexual coercion and injury. They will also complete the Danger Assessment, a 20-item measure to assess danger and lethality in a participant's experiences of violence and has documented reliability and validity. We will further assess safety with Steps for Safety instrument.The National Center for State Courts created the 18-item measure to document what safety steps a victim had taken post intervention. We will also receive Rochester Police Department (RPD) 911 call data, which is available to the public, and link the calls to our patients via address geomapping.

  2. Depression

    Time frame: 9 months

    To assess whether CHW-PSP leads to improved depression and health function post-intervention (9 months). The PHQ-9 is a screen for major depressive disorder with good discriminant validity and sensitivity to change that has been validated in variety of settings.

  3. Quality of Life

    Time frame: 12 months

    The effect of the Project Rose-SAFE intervention on the outcome of patient QoL will be mediated by increases in patient safety. The World Health Organization developed the WHOQOL-BREF to assess overall quality of life. It includes 4 summary scales: physical, psychological, social, and environment, plus a total score. The WHOQOL-BREF gives equal attention to the function and to a patient's assessment of the importance of that level of function, was designed to detect change over time, and is associated with change in depression.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Healing Through Education, Advocacy and Law (HEAL) in Response to Violence

Acronym: ROSE-SAFE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 10, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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