Realizing Opportunities for Self-Supported Improvement (ROSSI) (ROSE-SAFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03016481|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Domestic Violence Depression Quality of Life||Behavioral: Active Comparator: the Community Health Worker -Personalized Support for Progress Behavioral: Care as Usual- Social Worker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Healing Through Education, Advocacy and Law (HEAL) in Response to Violence|
|Actual Study Start Date :||April 15, 2017|
|Actual Primary Completion Date :||November 30, 2019|
|Actual Study Completion Date :||January 31, 2020|
Active Comparator: the Community Health Worker -Personalized Support for Progress
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.
Behavioral: Active Comparator: the Community Health Worker -Personalized Support for Progress
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 Name: CHW-PSP
Active Comparator: Care as Usual- Social Worker
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.
Behavioral: Care as Usual- Social Worker
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 Name: CAU-SW
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016481
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14620|
|Principal Investigator:||Catherine Cerulli, JD, PhD||University of Rochester|