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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02174224
Other study ID # OJJDP-2013-3579
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date April 2019

Study information

Verified date February 2021
Source Denver Health and Hospital Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if a hospital-based violence intervention programs can make sustainable behavior changes in at-risk youth using two key components, brief intervention at the hospital bedside and case management.


Description:

This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months. Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management. Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 24 Years
Eligibility Inclusion Criteria: - 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault) Exclusion Criteria: - Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Intervention
Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient. The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.
Case Management
Case management based on needs-assessment. Resource connection and mentoring.
Standard Medical Care
This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient. This will also include a list of resources that are typically needed and used for violently injured youth.

Locations

Country Name City State
United States Denver Health Medical Center Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Violence Risk Scale Violence Risk Scale (VRS) will be measured with each youth at 4 time points. Change over time will be assessed and compared among study arms. 0, 6, 12, 18 months
Secondary Composite Score Composite Score measures both risk and protective factors. This weighted scale uses the interplay between risk and protective factors to determine overall risk for youth to become violently injured. 0, 6, 12, 18 months
Secondary School Enrollment Self-report for school enrollment will be measured and compared among arms. 0, 6, 12, 18 months
Secondary Hospital Recidivism Every six month, patients' medical records will be scanned to determine if there has been violent injury recidivism. Medical release of Information forms will allow medical record searches from other local hospitals. 0, 6, 12, 18 months
Secondary Justice System Recidivism Self-report of criminal history. 0, 6, 12, 18 months
Secondary Employment Self-report of employment status. 0, 6, 12, 18 months
Secondary Resource Utilization Self report of resource utilization for health care and social needs. 0, 6, 12, 18 months.
Secondary Mortality Mortality will be assessed every 6 months. 0, 6, 12, 18 months
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