- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02174224
At-risk Intervention and Mentoring Evaluation (AIM)
Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80204
- Denver Health Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Violence Risk Scale
Zeitfenster: 0, 6, 12, 18 months
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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.
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0, 6, 12, 18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Composite Score
Zeitfenster: 0, 6, 12, 18 months
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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.
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0, 6, 12, 18 months
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School Enrollment
Zeitfenster: 0, 6, 12, 18 months
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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
Zeitfenster: 0, 6, 12, 18 months
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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
Zeitfenster: 0, 6, 12, 18 months
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Self-report of criminal history.
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0, 6, 12, 18 months
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Employment
Zeitfenster: 0, 6, 12, 18 months
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Self-report of employment status.
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0, 6, 12, 18 months
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Resource Utilization
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Katie Bakes, MD, Denver Health Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- OJJDP-2013-3579
Plan für individuelle Teilnehmerdaten (IPD)
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