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Firearm InjuryNCT06582953

HVIP Outcomes and Stakeholder Insights

A study testing Turning the Tide Violence Intervention Program (hospital violence intervention program) in people with Firearm Injury and Violence, Physical, run by Medical University of South Carolina at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Firearm Injury, Violence, Physical
What is being tested?
Turning the Tide Violence Intervention Program (hospital violence intervention program)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteUnited States
Study dates
5 Dec 2024to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • -Loved ones (partners), caregivers and family members of patients that enroll in the study that experienced violent injuries
  • -Healthcare team members that cared for victims of violence in the past 6 months

Who cannot join

  • 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
  • Non-English speaking
  • Cognitive impairment
  • Under age 16

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ashley Hink, MD contact

843-792-7082

hink@musc.edu

United States1 site, 1 recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29407

    Ashley Hink, MD, MPH, 843-792-6304, hink@musc.edu

    Recruiting

Other trials in United States

About this study

Official title: Advancing the Evidence for HVIPs in the Southeast: Comprehensive Patient- Centered Outcomes & Stakeholder Insights

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.

Read the detailed description

Evidence demonstrates that hospital violence intervention programs (HVIPs) reduce violent injury recidivism, PTSD symptoms, improve receipt of supportive services, and demonstrate cost-savings for the healthcare system. However, it is unknown if these outcomes can be replicated in under-studied communities in the Southeast (S.E.) where few HVIPs have been implemented, and other potentially valuable outcomes remain unexamined. These may include but are not limited to, improvement in patients' healthcare experiences, self-confidence, violence risk reduction, and overall recovery. In addition, multi-sector stakeholder perspectives on how HVIPs can improve or expand to better meet communities' needs are lacking in the literature. For instance, family members and loved ones are often supported by HVIP services, but little is known about how they benefit from the intervention. Also, HVIPs integrate into the healthcare team, augmenting the care provided by the clinical staff. Little is known about how healthcare teams benefit from the work of HVIPs or how the quality of care provided is influenced by these programs. These questions are imperative to informing the implementation of HVIPs and how success might be better defined through a public health lens that considers outcomes beyond violent injury recidivism for patients, families, healthcare systems, and communities.

Further, evaluating HVIPs in under-studied communities is critical to advancing the model's evidence base, especially in communities where violence intervention investment remains low. The S.E. U.S., for example, experiences a disproportionate burden of firearm homicide, but few hospitals have adopted HVIPs. S.E. trauma centers and HVIPs uniquely serve large urban and rural geographic areas that face complex racial and economic disparities yet have fewer investments in violence prevention and safety net policies and services.

Investigators propose conducting a comprehensive evaluation of an established HVIP (Turning the Tide Violence Intervention Program, TTVIP) at an academic, non-profit level 1 trauma center in Charleston, SC that serves youth and young adult victims of community and interpersonal violence in Charleston, Dorchester, and Berkeley Counties. Most patients served by the TTVIP are victims of firearm injury (\>90%), reside in the cities of Charleston and North Charleston - the latter of which ranks among U.S. cities with the highest firearm assault and homicide rates - and are disproportionately young Black males from neighborhoods with high deprivation and are Medicaid funded or uninsured. This study will advance the knowledge on HVIP outcomes, implementation from the perspective of survivors, families and healthcare team members, in addition to examining the impact of an HVIP in a S.E. state that disproportionately experiences firearm violence. The study's goal is to perform an evaluation of a S.E. HVIP (TTVIP) that includes comprehensive patient outcomes, perceived benefits of HVIPs from the perspectives of multiple stakeholders, and opportunities for HVIP improvement.

Aim 1: Assess healthcare experience, supportive service utilization, violence risk, mental health outcomes, self-confidence, perceived risk of violence and re-injury among violently injured youth and young adults, including TTVIP enrolled patients and non-enrolled patients. Investigators hypothesize that individuals that experienced violent injury and enrolled in the TTVIP will report a) more positive perception of their healthcare experience, b) higher service utilization, c) lower rates of depression and PTSD, d) lower risk of violence, e) higher confidence, and f) lower rates of violent and non-violent re-injury compared to non-enrolled victims of violence. Investigators anticipate similar rates of perceived violence risk between the two groups.

Aim 2: Examine perceptions of HVIP services, benefits, and recommendations for service improvement among HVIP enrollees and their primary caregivers/loved ones.

Aim 3: Assess perceptions of HVIP services, benefits to the healthcare team and patients, and recommendations for service improvements among healthcare staff.

Being tested
Turning the Tide Violence Intervention Program (hospital violence intervention program)
Keywords
violence, violence intervention programs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06582953
Study groupRoleWhat they receive
Patients, family members and healthcare providersOtherPatients 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.
Receives: Behavioral: Turning the Tide Violence Intervention Program (hospital violence intervention program)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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).

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

  8. 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.

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

  9. 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.

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

  10. 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.

    Measured: 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.

  11. 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.

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

  12. 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.

    Measured: 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.

  13. 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.

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

  14. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start5 Dec 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06582953
Sponsor's protocol ID
Pro00138225
Status last verified
Apr 2026
First submitted
11 Aug 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not indicated

Publications

  • 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.

    PubMed 28395357
  • 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.

    PubMed 34416223
  • 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.

    PubMed 30095028
  • 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.

    PubMed 25442223
  • 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.

    PubMed 23511134
  • 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.

    PubMed 36102509

Questions about this trial

What is this clinical trial studying?

A study testing Turning the Tide Violence Intervention Program (hospital violence intervention program) in people with Firearm Injury and Violence, Physical, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ashley Hink, MD (843-792-7082, hink@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Traumatic Stress Disorder (time frame: Victims of violence will be screened at baseline enrollment, 3 months, 6 months and 12 months after enrollment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06582953, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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