OBJECTIVE: To develop, in partnership with families of children with traumatic brain injury, a postdischarge intervention that is effective, simple, and sustainable. DESIGN: Randomized Controlled Trial. SETTING:Seven Level 1 Pediatric Trauma Centers in Argentina. PATIENTS: Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild traumatic brain injury and were discharged alive. INTERVENTIONS: Patients were randomly assigned to either the intervention or standard care group. A specially trained Community Resource Coordinator was assigned to each family in the intervention group. We hypothesized that children with severe, moderate, and complicated mild traumatic brain injury who received the intervention would have significantly better functional outcomes at 6 months post discharge than those who received standard care. We further hypothesized that there would be a direct correlation between patient outcome and measures of family function. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was a composite measured at 6 months post injury. There were 308 patients included in the study (61% men). Forty-four percent sustained a complicated mild traumatic brain injury, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and the scores on the Family Impact Module of the Pediatric Quality of Life Inventory (ρ = 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6 months post injury. CONCLUSIONS: Although no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with traumatic brain injury spanning hospital transport through hospital care and into the postdischarge setting.
RCT Entities:
OBJECTIVE: To develop, in partnership with families of children with traumatic brain injury, a postdischarge intervention that is effective, simple, and sustainable. DESIGN: Randomized Controlled Trial. SETTING: Seven Level 1 Pediatric Trauma Centers in Argentina. PATIENTS: Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild traumatic brain injury and were discharged alive. INTERVENTIONS:Patients were randomly assigned to either the intervention or standard care group. A specially trained Community Resource Coordinator was assigned to each family in the intervention group. We hypothesized that children with severe, moderate, and complicated mild traumatic brain injury who received the intervention would have significantly better functional outcomes at 6 months post discharge than those who received standard care. We further hypothesized that there would be a direct correlation between patient outcome and measures of family function. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was a composite measured at 6 months post injury. There were 308 patients included in the study (61% men). Forty-four percent sustained a complicated mild traumatic brain injury, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and the scores on the Family Impact Module of the Pediatric Quality of Life Inventory (ρ = 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6 months post injury. CONCLUSIONS: Although no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with traumatic brain injury spanning hospital transport through hospital care and into the postdischarge setting.
Authors: Patrick M Kochanek; Nancy Carney; P David Adelson; Stephen Ashwal; Michael J Bell; Susan Bratton; Susan Carson; Randall M Chesnut; Jamshid Ghajar; Brahm Goldstein; Gerald A Grant; Niranjan Kissoon; Kimberly Peterson; Nathan R Selden; Robert C Tasker; Karen A Tong; Monica S Vavilala; Mark S Wainwright; Craig R Warden Journal: Pediatr Crit Care Med Date: 2012-01 Impact factor: 3.624
Authors: Monica S Vavilala; Silvia B Lujan; Qian Qiu; Gustavo J Petroni; Nicolás M Ballarini; Nahuel Guadagnoli; María Alejandra Depetris; Gabriela A Faguaga; Gloria M Baggio; Leonardo O Busso; Mirta E García; Osvaldo R González Carrillo; Paula L Medici; Silvia S Sáenz; Elida E Vanella; Anthony Fabio; Michael J Bell Journal: PLoS One Date: 2016-12-22 Impact factor: 3.240
Authors: Anelia A Y Kassi; Anil K Mahavadi; Angelica Clavijo; Daniela Caliz; Stephanie W Lee; Aminul I Ahmed; Shoji Yokobori; Zhen Hu; Markus S Spurlock; Joseph M Wasserman; Karla N Rivera; Samuel Nodal; Henry R Powell; Long Di; Rolando Torres; Lai Yee Leung; Andres Mariano Rubiano; Ross M Bullock; Shyam Gajavelli Journal: Front Neurol Date: 2019-01-17 Impact factor: 4.086
Authors: Monica S Vavilala; Silvia B Lujan; Qian Qiu; Michael J Bell; Nicolás M Ballarini; Nahuel Guadagnoli; María Alejandra Depetris; Gabriela A Faguaga; Gloria M Baggio; Leonardo O Busso; Mirta E García; Osvaldo R González Carrillo; Paula L Medici; Silvia S Sáenz; Elida E Vanella; Carly K Farr; Gustavo J Petroni Journal: PLoS One Date: 2017-12-15 Impact factor: 3.240