At-risk Intervention and Mentoring Evaluation (AIM)
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|ClinicalTrials.gov Identifier: NCT02174224|
Recruitment Status : Recruiting
First Posted : June 25, 2014
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment|
|Violence||Behavioral: Brief Intervention Behavioral: Case Management Behavioral: Standard Medical Care|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: SMC + BI + Case Management
This arm will include all interventions in Standard Medical Care + Brief Intervention Arm. Case management will also be given to this arm. General needs based assessments will be conducted by the outreach worker. These assessments will be done at the hospital or at the youth's home, whichever they prefer. This assessment tool addresses education, vocational training, employment, housing, medical insurance, follow-up care and pro-social activities. Although each youth in this arm will receive the same needs-based assessment, individual youth will have variable needs, which will guide each unique and individualized case management plan.
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.Behavioral: Case Management
Case management based on needs-assessment. Resource connection and mentoring.Behavioral: 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.
- Violence Risk Scale [ Time Frame: 0, 6, 12, 18 months ]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.
- Composite Score [ Time Frame: 0, 6, 12, 18 months ]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.
- School Enrollment [ Time Frame: 0, 6, 12, 18 months ]Self-report for school enrollment will be measured and compared among arms.
- Hospital Recidivism [ Time Frame: 0, 6, 12, 18 months ]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.
- Justice System Recidivism [ Time Frame: 0, 6, 12, 18 months ]Self-report of criminal history.
- Employment [ Time Frame: 0, 6, 12, 18 months ]Self-report of employment status.
- Resource Utilization [ Time Frame: 0, 6, 12, 18 months. ]Self report of resource utilization for health care and social needs.
- Mortality [ Time Frame: 0, 6, 12, 18 months ]Mortality will be assessed every 6 months.
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): NCT02174224
|Contact: Sara Muramoto, BS||3036025154||Sara.Muramoto@dhha.org|
|Contact: Katie Bakes, MD||3036025150||Katie.Bakes@dhha.org|
|United States, Colorado|
|Denver Health Medical Center||Recruiting|
|Denver, Colorado, United States, 80204|
|Principal Investigator: Katie Bakes, MD|
|Principal Investigator:||Katie Bakes, MD||Denver Health Medical Center|