Clinical trial NCT06582953: HVIP Outcomes and Stakeholder Insights
Official title: Advancing the Evidence for HVIPs in the Southeast: Comprehensive Patient- Centered Outcomes & Stakeholder Insights
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Firearm Injury
Violence, Physical
Keywords: violence
violence intervention programs
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 220
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 (\&amp;gt;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.

Eligibility criteria: Inclusion Criteria (patients):

* Patients ages 16-35 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

Exclusion Criteria (patients):

* 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 15, over 35

Inclusion Criteria (loved ones/caregivers):

-Loved ones (partners), caregivers and family members of patients that enroll in the study that experienced violent injuries

Exclusion Criteria (loved ones/caregivers):

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

Inclusion Criteria (Healthcare Providers):

-Healthcare team members that cared for victims of violence in the past 6 months

Primary outcomes:
measure: Post Traumatic Stress Disorder
timeFrame: Victims of violence will be screened at baseline enrollment, 3 months, 6 months and 12 months after enrollment
measure: Self-Esteem
timeFrame: Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months
measure: Future Firearm Violence Risk
timeFrame: Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months after enrollment.
measure: Depression
timeFrame: Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment.
measure: Benefits of hospital violence intervention program implementation
timeFrame: Healthcare providers will be assessed with baseline assessment at enrollment (1 time cross-sectional survey)
measure: Percentage of Patients with Criminal justice system involvement
timeFrame: Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment
measure: Percentage of Patients with Adverse Social Determinants of Health
timeFrame: Victims of violence will be assessed at baseline, 3 months, 6 months and 12 months after enrollment
measure: Percentage of patients with perceived risk of violence
timeFrame: Victims of violence will be assessed at baseline enrollment, 3 months, 6 months and 12 months after enrollment.
measure: Percentage of patients experiencing a repeat injury
timeFrame: Victims of violence will be assessed at 3 months, 6 months and 12 months after enrollment
measure: Percentage of patients with recovery service needs
timeFrame: 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.
measure: Percentage of patients reporting threats of violence
timeFrame: Victims of violence will be assessed 3 months, 6 months and 12 months after enrollment.
measure: Percentage of patients reporting favorable outcomes of Violence Intervention Services
timeFrame: 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.
measure: Percentage of Patients Reporting Favorable Quality of Health Care
timeFrame: Victims of violence and loved ones/caregivers will be assessed at baseline enrollment and 3 months after enrollment.
measure: Percentage of patients enrolled in hospital violence intervention program
timeFrame: Victims of violence will be asked at baseline enrollment, 3 months, 6 months and 12 months after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Ashley Hink, MD
role: PRINCIPAL_INVESTIGATOR
References: