Clinical trial NCT03896789: Pediatric Guideline Adherence and Outcomes- Argentina
Official title: Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: guideline adherence
implementation fidelity
pediatric
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
name: Centro de Informática e Investigación Clínica (CIIC)
name: Washington State University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-04-01
Enrollment: 505
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Mechanism or head CT consistent with TBI
* \<18 years old
* Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated

Exclusion Criteria:

- none

Primary outcomes:
measure: First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall
timeFrame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Secondary outcomes:
measure: Clinical Pathway Adoption
timeFrame: Started within 24 hours of patient eligibility (at admission or deterioration)
measure: Glasgow Outcome Scale (GOS) Score at Discharge
timeFrame: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
measure: Discharge Survival
timeFrame: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
measure: Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)
timeFrame: 3 months post-admission
measure: Mortality, 3-Month
timeFrame: 3 months post admission
Other outcomes:
measure: Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status
timeFrame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Locations:
city: Florencio Varela
country: Argentina
facility: Hospital el Cruce
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Sor Ludovica
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Hospital Interzonal Especializado Materno Infantil
state: Buenos Aires
city: San Justo
country: Argentina
facility: Hospital Municipal del Nino de San Justo
state: Buenos Aires
city: San Fernando Del Valle De Catamarca
country: Argentina
facility: Hospital de Ninos Eva Peron
state: Catamarca
city: San Salvador De Jujuy
country: Argentina
facility: Hospital Materno Infantil Dr. Hector Quintana
state: Jujuy
city: Reconquista
country: Argentina
facility: Hospital Regional Reconquista
state: Santa Fe
city: Rosario
country: Argentina
facility: Hopital Victor J. Vilela
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Hospital del Nino Jesus
state: Tucuman
city: Cordoba
country: Argentina
facility: Hospital de La Santisima Trinidad
city: Mendoza
country: Argentina
facility: Hospital Humberto Notti
city: Salta
country: Argentina
facility: Hospital Publico Materno Infantil
city: Santa Fe
country: Argentina
facility: Hospital Alassia
city: Santiago Del Estero
country: Argentina
facility: Centro Provincial de Salud Infantil Eva Peron
city: Valparaíso
country: Chile
facility: Hospital Carlos Van Buren
city: Asuncion
country: Paraguay
facility: Hospital de Trauma Manuel Giagni
Study officials:
affiliation: University of Washington
name: Monica Vavilala, MD
role: PRINCIPAL_INVESTIGATOR
References: