Evaluation of Trauma Center-Based, Technology-Enhanced Stepped Care Intervention for Adolescent Traumatic Injury

Date Added
August 3rd, 2021
PRO Number
Pro00111879
Researcher
Tatiana Davidson

List of Studies


Keywords
Adolescents, Mental Health
Summary

Pediatric traumatic injury is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression, deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. In 2015 our team launched the Trauma Resilience and Recovery Program (TRRP) at Medical University of South Carolina, a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care – one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. We have found this model of care to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to best-practice telehealth-based or in-person assessment and treatment. We have partnered with three accredited Level I and II pediatric trauma centers, Prisma-Health Upstate, Children's of Alabama, and Boston Children's Hospital, and propose a multi-site hybrid 1 effectiveness-implementation randomized controlled trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. This study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.

Institution
MUSC
Recruitment Contact
Olivia Eilers
843-792-0979
eilerso@musc.edu

20190341: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Date Added
July 8th, 2026
PRO Number
Pro00150758
Researcher
Wael Ghalayini

List of Studies

Keywords
Cancer/Lung
Summary

This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Freida Davidson
843-674-5172
cormackf@musc.edu



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