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Early rehabilitation protocol in the pediatric ICU for children with acute brain injury
Investigator (PI): Fink, Ericka
Performing Organization (PO): (Current): University of Pittsburgh, School of Medicine, Department of Critical Care Medicine / (412) 647-3136
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/CER-1310-08343
Funding: Total Award Amount: $921,322
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessen debilitation and promote return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, benefits of ERP for this group have not been studied and are not standard of care in pediatric ICUs. Objectives. The aims of this study are 1) to better understand current practices and barriers to use of these therapies and 2) to subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be superior compared to the usual care group. Methods. The first task of this research program is to survey health care professionals (physicians, nurses, allied health) and families of children in the ICU about their hospital's resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of ICU admission and those in the usual care group will begin therapies when these services are ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child's clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS) pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical and cognitive function as well as behavior. Other tests will be performed that assess child and family quality of life and length of hospital admission. Our outcome tests were chosen because 1) they are the most important outcomes to families of children as surveyed in our ICU and 2) they are outcomes that can be influenced by ERP. Summary. This is the first and largest study designed to evaluate whether ERP improves outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will have superior adaptive and quality of life outcomes, outcomes important to families, without increasing adverse events compared to patients in the usual care group.
MeSH Terms:
  • Adolescent
  • Brain Injuries /*rehabilitation
  • Child
  • Child Behavior
  • Child, Preschool
  • Cognition
  • Critical Care /*organization & administration
  • Critical Illness
  • Disabled Persons
  • Health Services Accessibility
  • Humans
  • * Intensive Care Units
  • Outcome Assessment, Health Care
  • Patient Admission
  • Pediatrics /*organization & administration
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Treatment Outcome
Country: United States
State: Pennsylvania
Zip Code: 15261
UI: 20152190
CTgovId: NCT02209935
Project Status: Completed
Record History: ('2018: Project extended to 2019',) ('2017: Project extended to 2018',)