HVIP Outcomes and Stakeholder Insights

NCT06582953 | Recruiting

• 1 other identifier: Pro00138225
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The study's goal is to perform an evaluation of a Southeastern hospital violence intervention program (HVIP) that includes comprehensive patient outcomes, perceived benefits and opportunities for improvement of an HVIP from the perspectives of multiple stakeholders including patients, family members and healthcare providers.

Conditions

Firearm Injury; Violence, Physical

Keywords

violence; violence intervention programs

Outcome Measures

Primary Outcomes (14)

• Post Traumatic Stress Disorder

  PTSD: PTSD Checklist for DSM-5 (PCL) The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: Not at all, A little bit, Moderately, Quite a bit, and Extremely. They are scored 0-4. The score is totaled (0-80), with a cut-off of 33 being indicative of PTSD and higher scores indicating worse symptoms.

  Victims of violence will be screened at baseline enrollment, 3 months, 6 months and 12 months after enrollment

• Self-Esteem

  Self esteem will be assessed using he Rosenberg Self Esteem Scale. This is a 10-item scale with response options that indicate level of agreement (strongly agree, agree, disagree, strongly disagree) related to statements of self esteem. Responses are scored (1-4), and totaled. Higher scores indicate higher self-esteem.

  Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months

• Future Firearm Violence Risk

  Future risk of firearm violence will be assessed with the SaFTEy Score (Serious fighting, Friend weapon carrying, community Environment, and firearm Threats). This is a 4 -item survey that assesses future risk of experiencing firearm violence. Each response is scored and all are totaled. Scores range 0-10, and 10 indicates high risk of future violence.

  Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months after enrollment.

• Depression

  The PHQ-9 (patient health questionnaire) is used to assess for depression. It is a 9 item instrument that asks about depressive symptoms. Each question has a 4 response option that assesses for frequency of having symptoms, and each question is scored 0-3. The total score ranges from 0-27. 0 - 4 indicates no depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms.

  Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment.

• Benefits of hospital violence intervention program implementation

  Healthcare providers will be surveyed on perceptions of the implementation of the Turning the Tide Violence Intervention Program (TTVIP). This is not an instrument, but questions assessing the following domains will be asked in a survey: knowledge of TTVIP services, impact on communication, medical care, trauma informed care, culturally competent care, and patient outcomes. Answer options will be based on level of agreement. Results will be reported by percentage of individuals reporting the response options.

  Healthcare providers will be assessed with baseline assessment at enrollment (1 time cross-sectional survey)

• Percentage of Patients with Criminal justice system involvement

  There will not be an instrument used. Rather, subjects will be asked if they have been subject to criminal charges, arrest and incarceration. The answer options will be in a yes/no format, and the outcome will be reported by incidence (percentage of individuals indicating criminal justice system involvement).

  Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment

• Percentage of Patients with Adverse Social Determinants of Health

  Social Determinants of Health will be assessed with the Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening tool. This tool assesses social determinants of health (SDoH) and domains being assessed for this study include housing, safety, food insecurity, transportation, ability to afford basic needs, ability to pay for utilities, employment, and social support. The questions are not scored nor is a scale used, and response options are in the form of yes/no, multiple choices categories and frequencies. Results will be reported by incidence (percentage of subjects reporting the option).

  Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months after enrollment

• Percentage of patients with perceived risk of violence

  An instrument will not be used. The participant will be asked in a survey to indicate their level of agreement to a statement about feeling at risk of being a victim of violence. The result will be reported by the percentage of each response.

  Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment.

• Percentage of patients experiencing a repeat injury

  An instrument will not be used. Subjects will be asked if they have experienced a repeat injury (violent or non-violent) since enrollment in the study via survey question.

  Victims of violence will be assessed at 3 months, 6 months and 12 months after enrollment

• Percentage of patients with recovery service needs

  This will not be an instrument. Participants will be asked in a survey to indicate which services they feel like they need to recover after experiencing injury by selecting the boxes that they feel apply (services: medical/surgical, physical therapy, occupational therapy, social work, housing assistance, food assistance, transportation assistance, financial assistance, health insurance, conflict resolution, education, employment, accessing victims of crime services, legal services). Results will be reported by the percentage of individuals indicating service needs.

  Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after injury. Patient loved ones/caregivers will be assessed at baseline and 3-6 months after injury.

• Percentage of patients reporting threats of violence

  This will not be assessed with an instrument. This will be assessed with a survey question asking if the patient has experienced threats of violence.

  Victims of violence will be assessed 3 months, 6 months and 12 months after enrollment.

• Percentage of patients reporting favorable outcomes of Violence Intervention Services

  The iMPRoVE (Measures for Providers to Victimization Experiences) is a survey that assesses the outcomes and quality of victim intervention services within the following domains: legal/justice system, medical care and coordination, mental health focused services, crisis intervention and referral services, supportive or community advocacy services, and underserved population focused services. Each question is designed to assess if the TTVIP provided services that were perceived as beneficial to the individual related to the domain. There are two question banks - one for individuals/victims, and one for proxy (caregivers, loved ones, family members). Each question has a response option (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). It is not scaled or scored, but rather each response indicates the level of agreement to the question or statement. Results will be reported by the percentage of individuals answering the options.

  Patients enrolled in TTVIP will be assessed at the following intervals after enrollment: 3 months, 6 months and 12 months. Loved ones/caregivers will be assessed with proxy questions 3-6 months after their loved one was enrolled.

• Percentage of Patients Reporting Favorable Quality of Health Care

  This will not be assessed with an instrument. Questions will be administered via survey assessing the following domains of participant perception of their healthcare: communication, cultural competence, empathy, and bias. Questions will be assessed by level of agreement and reported by percentage reporting the responses.

  Victims of violence and loved ones/caregivers will be assessed at baseline enrollment and 3 months after enrollment.

• Percentage of patients enrolled in hospital violence intervention program

  Subjects will be asked if they are enrolled in the Turning the Tide Violence Intervention Program. It will be a yes or no question, and be reported by incidence (percentage of subjects enrolled).

  Victims of violence will be asked at baseline enrollment, 3 months, 6 months and 12 months after enrollment.

Study Arms (1)

Patients, family members and healthcare providers

OTHER

Patients that experience violent injuries or are high risk of violence between ages of 15-35 and treated at MUSC Charleston will be enrolled. The hospital violence intervention program is incorporated into regular care of patients, and they may opt to receive services from the program (TTVIP) if they qualify and opt to participate. There is no randomization or assignment. Investigators will assess outcomes of these patients and outcomes will be assessed for between group differences between those that receive services from the program and those that do not. Patient family members and healthcare providers that care for patients will be included and are exposed to the regular healthcare and services provided to patients.

Behavioral: Turning the Tide Violence Intervention Program (hospital violence intervention program)

Interventions

Turning the Tide Violence Intervention Program (hospital violence intervention program) BEHAVIORAL

TTVIP is already integrated into the regular care of patients who are violently injured and treated at MUSC Charleston. Client advocates provide immediate support, help with communication and provide anti-retaliation messaging to victims of violence and their families, in addition to helping support their healthcare. Patients that opt to be followed for long-term wrap-around services and live in the surrounding 3-county area are supported for months (up to 1 year) after injury and provided mentorship, service referrals (i.e. education, employment, substance abuse, injury recovery, pro-social activities, housing) and mental health services.

Patients, family members and healthcare providers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 16 and above treated at MUSC Charleston that experience an injury due to interpersonal or community violence
• Glasgow coma score (GCS) of 15 at the time of study enrollment

You may not qualify if:

• Lack of capacity to consent due to altered mental status (AMS) or severe untreated mental illness
• Being under arrest or incarcerated at the time of assessment for enrollment
• Non-English speaking patients
• Ages under 16
• Loved ones (partners), caregivers and family members of patients that enroll in the study that experienced violent injuries
• Non-English speaking
• Cognitive impairment
• Under age 16
• Healthcare team members that cared for victims of violence in the past 6 months

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

RECRUITING

Related Publications (6)

• Goldstick JE, Carter PM, Walton MA, Dahlberg LL, Sumner SA, Zimmerman MA, Cunningham RM. Development of the SaFETy Score: A Clinical Screening Tool for Predicting Future Firearm Violence Risk. Ann Intern Med. 2017 May 16;166(10):707-714. doi: 10.7326/M16-1927. Epub 2017 Apr 11.

  PMID: 28395357 BACKGROUND

• Kegler SR, Dahlberg LL, Vivolo-Kantor AM. A descriptive exploration of the geographic and sociodemographic concentration of firearm homicide in the United States, 2004-2018. Prev Med. 2021 Dec;153:106767. doi: 10.1016/j.ypmed.2021.106767. Epub 2021 Aug 17.

  PMID: 34416223 BACKGROUND

• Monopoli WJ, Myers RK, Paskewich BS, Bevans KB, Fein JA. Generating a Core Set of Outcomes for Hospital-Based Violence Intervention Programs. J Interpers Violence. 2021 May;36(9-10):4771-4786. doi: 10.1177/0886260518792988. Epub 2018 Aug 10.

  PMID: 30095028 BACKGROUND

• Purtle J, Rich LJ, Bloom SL, Rich JA, Corbin TJ. Cost-benefit analysis simulation of a hospital-based violence intervention program. Am J Prev Med. 2015 Feb;48(2):162-169. doi: 10.1016/j.amepre.2014.08.030. Epub 2014 Nov 6.

  PMID: 25442223 BACKGROUND

• Smith R, Dobbins S, Evans A, Balhotra K, Dicker RA. Hospital-based violence intervention: risk reduction resources that are essential for success. J Trauma Acute Care Surg. 2013 Apr;74(4):976-80; discussion 980-2. doi: 10.1097/TA.0b013e31828586c9.

  PMID: 23511134 BACKGROUND

• Gorman E, Coles Z, Baker N, Tufariello A, Edemba D, Ordonez M, Walling P, Livingston DH, Bonne S. Beyond Recidivism: Hospital-Based Violence Intervention and Early Health and Social Outcomes. J Am Coll Surg. 2022 Dec 1;235(6):927-939. doi: 10.1097/XCS.0000000000000409. Epub 2022 Nov 15.

  PMID: 36102509 BACKGROUND

Related Links

• Gun violence information in rural areas
• HAVI membership
• TTVIP website
• ADI linkage (area deprivation index)
• City level data on firearm homicide
• Adverse child events screening
• Rosenburg self esteem scale
• PTSD screening
• PHQ-9 depression screening
• health related needs (social determinants of health) screening

Study Officials

• Ashley Hink, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Hink, MD

CONTACT

843-792-7082; hink@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: September 3, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)