Pediatric Guideline Adherence & Outcomes- Argentina

Status Completed

Clinical Trial Summary

Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.

Clinical Trial Description

Specific Aim 1: Determine the relationship between PEGASUS program implementation and TBI guideline adherence (Aim 1a), and assess system, provider, patient, implementation and guideline factors associated with TBI guideline adherence (Aim 1b). Hypothesis: Centers that receive the PEGASUS program have higher TBI guideline adherence (main outcome), as well as better discharge survival and 3-month Glasgow Outcome Scale-Extended (GOSE) score (secondary outcomes) than centers who receive usual care. Specific Aim 2: Create a value stream map (VSM) to identify value-added processes of care associated with TBI guideline adherence. Hypothesis: ICU activity flows of TBI care during the first 72 hours will reveal value-added as well as non-value-added processes in severe TBI care. PEGASUS program implementation will result in more value-added TBI care processes and better TBI guideline adherence. Specific Aim 3: Use computer simulation to develop and disseminate a real-world best practices blueprint for TBI guideline adherence. Hypothesis: This model will identify the impact of the PEGASUS program on key performance indicators (KPIs), outcomes (Aim 1), and process activities (Aim 2). Iterative computer simulations will then demonstrate the relationship among PEGASUS program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in TBI care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03896789
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2019
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04526639` - VR Cognitive Rehabiliation for Pediatric TBI	N/A
Recruiting	`NCT05943756` - Evaluation of Well-being Interventions in Adults With TBI	N/A
Completed	`NCT01339702` - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Completed	`NCT00760734` - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)	Phase 1
Not yet recruiting	`NCT06024122` - Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Completed	`NCT03225768` - Guided Training for People With Cognitive Impairment	N/A
Completed	`NCT04590911` - Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood	N/A
Recruiting	`NCT04121780` - Growth Hormone Replacement Therapy for Retried Professional Football Players	Phase 2
Completed	`NCT04776304` - Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms	N/A
Completed	`NCT00409058` - Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI	N/A
Completed	`NCT00205491` - Pharmacological Intervention in Depression After Traumatic Brain Injury	Phase 4
Completed	`NCT03490110` - Brain Markers of Improvements in Cognitive Functioning	N/A
Active, not recruiting	`NCT02525432` - Autologous Stem Cell Study for Adult TBI (Phase 2b)	Phase 2
Completed	`NCT02858544` - Concussion in Motor Vehicle Accidents: The Concussion Identification Index	N/A
Completed	`NCT01728831` - Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury	N/A
Recruiting	`NCT06005194` - InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI	N/A
Not yet recruiting	`NCT05340803` - Sedation of Ventilated Traumatic Brain Injury Patients With Midazolam Alone Versus Combination With Dexmedetomidine or Magnesium Sulfate; Monitored by Ultrasonograghic Optic Nerve Sheath Diameter	Phase 3
Recruiting	`NCT06195345` - Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Recruiting	`NCT04279431` - Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One
Completed	`NCT01948947` - Improving Functions in MTBI Patients With Headache by rTMS	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pediatric Guideline Adherence and Outcomes- Argentina

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms