- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02174224
At-risk Intervention and Mentoring Evaluation (AIM)
Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80204
- Denver Health Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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 based on needs-assessment.
Resource connection and mentoring.
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Violence Risk Scale
Tidsramme: 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.
|
0, 6, 12, 18 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite Score
Tidsramme: 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.
|
0, 6, 12, 18 months
|
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School Enrollment
Tidsramme: 0, 6, 12, 18 months
|
Self-report for school enrollment will be measured and compared among arms.
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0, 6, 12, 18 months
|
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Hospital Recidivism
Tidsramme: 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.
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0, 6, 12, 18 months
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Justice System Recidivism
Tidsramme: 0, 6, 12, 18 months
|
Self-report of criminal history.
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0, 6, 12, 18 months
|
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Employment
Tidsramme: 0, 6, 12, 18 months
|
Self-report of employment status.
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0, 6, 12, 18 months
|
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Resource Utilization
Tidsramme: 0, 6, 12, 18 months.
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Self report of resource utilization for health care and social needs.
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0, 6, 12, 18 months.
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Mortality
Tidsramme: 0, 6, 12, 18 months
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Mortality will be assessed every 6 months.
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0, 6, 12, 18 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Katie Bakes, MD, Denver Health Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- OJJDP-2013-3579
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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