At-risk Intervention and Mentoring Evaluation (AIM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Denver Health and Hospital Authority
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT02174224
First received: June 23, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Violence
Behavioral: Brief Intervention
Behavioral: Case Management
Behavioral: Standard Medical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Violence Risk Scale [ Time Frame: 0, 6, 12, 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Composite Score [ Time Frame: 0, 6, 12, 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-report for school enrollment will be measured and compared among arms.

  • Hospital Recidivism [ Time Frame: 0, 6, 12, 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-report of criminal history.

  • Employment [ Time Frame: 0, 6, 12, 18 months ] [ Designated as safety issue: No ]
    Self-report of employment status.

  • Resource Utilization [ Time Frame: 0, 6, 12, 18 months. ] [ Designated as safety issue: No ]
    Self report of resource utilization for health care and social needs.

  • Mortality [ Time Frame: 0, 6, 12, 18 months ] [ Designated as safety issue: No ]
    Mortality will be assessed every 6 months.


Estimated Enrollment: 1000
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Medical Care (SMC)
Standard Medical Care Arm will receive the local standard of care, which includes medical treatment and a potential for a social worker consult at the physician's discretion. This will also include a standard list of resources that are generally needed and used by violently injured youth.
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.
Experimental: SMC + Brief Intervention (BI)
Inclusive of the Standard Medical Care Arm plus this arm will receive a brief intervention. In the brief intervention 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: 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: 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.
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.

Detailed 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 three arms. Arm 1 will receive the standard of care according to hospital standards. Arm 2 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 3 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).

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02174224

Contacts
Contact: Sara Muramoto, BS 3036025154 Sara.Muramoto@dhha.org
Contact: Katie Bakes, MD 3036025150 Katie.Bakes@dhha.org

Locations
United States, Colorado
Denver Health Medical Center Not yet recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Katie Bakes, MD         
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
Principal Investigator: Katie Bakes, MD Denver Health Medical Center
  More Information

No publications provided

Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02174224     History of Changes
Other Study ID Numbers: OJJDP-2013-3579
Study First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
Violence
At-risk youth
Intentional Injury
Violence Intervention
Youth
recidivism

ClinicalTrials.gov processed this record on October 19, 2014