Table 1 ClinicalTrials.gov registration data

NCT Number ^ICMJE

NCT03896789

Other Study ID Numbers ^ICMJE

STUDY00005629 1R01NS106560-01A1 ( U.S. NIH Grant/Contract)

Last Update Posted Date

December 10, 2021

First Submitted Date ^ICMJE

January 7, 2019

First Posted Date ^ICMJE

April 1, 2019

Primary Outcome Measures ^ICMJE (submitted: March 27, 2019)

TBI guideline adherence [Time Frame: ICU Stay, approximately up to 2 weeks ]

The main outcome will be measured as the sum of indicators to which care was adhered by the number of relevant adherence indicators for a given patient during ICU stay.

Secondary Outcome Measures ^ICMJE (submitted: November 25, 2019)

• Clinical Pathway Adoption [ Time Frame: within 24 hours of patient admission ]

• Discharge Survival [ Time Frame: At Hospital Discharge, approximately up to 5 weeks ]

• GOSE-Peds. Pediatric Version of the Glasgow Outcome Scale-Extended [ Time Frame: 3 months post discharge ]

• Mortality [ Time Frame: 3 months post discharge ]

• DIBQ (Determinants of Implementation Behaviors Scale) [Time Frame: Baseline, and quarterly during year 1 after randomization; then once annually through study completion, approximately 3 years, for intervention sites.]

• Value added processes assessed by Organizational Questionnaire for Participant Hospitals [Time Frame: Baseline and annually through study completion, approximately 3 years]

• Changes in patient outcomes from time in - to time out- of the system based on manipulations of KPIs [Time Frame: during ICU care, approximately up to 2 weeks]

Brief Title ^ICMJE

Pediatric Guideline Adherence and Outcomes- Argentina

Official Title ^ICMJE

Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description:

Parallel cluster RCT following a baseline data collection period when all sites are in the 'control/usual care state'.

Masking: None (Open Label)

Primary Purpose: Health Services Research

Condition ^ICMJE

TBI (Traumatic Brain Injury)

Intervention ^ICMJE

Other: PEGASUS Program for Care

This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.

Study Arms ^ICMJE

• No Intervention: Baseline

All sites will collect usual care data from 9 months to 21 months.

• Experimental: PEGASUS Program (Intervention)

This arm (half of the sites) will receive the PEGASUS program (intervention) from 21 months to 57 months.

Intervention: Other: PEGASUS Program for Care

• No Intervention: Usual Care (Control)

This arm (half of the sites) will maintain usual care. They will receive the opportunity for the PEGASUS program training (intervention) at the end of study data collection (57 months) period.

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE (submitted: March 27, 2019)

540

Actual Study Start Date ^ICMJE

September 1, 2019

Estimated Primary Completion Date

September 30, 2023 (Final data collection date for primary outcome measure)

Estimated Study Completion Date ^ICMJE

December 31, 2023

Eligibility Criteria ^ICMJE

Inclusion Criteria:

• Mechanism or head CT consistent with TBI

• < 18 years old

• GCS (Glasgow Coma Scale) score ≤8 at any point during hospital admission

Exclusion Criteria:- none

Listed Location Countries ^ICMJE

Argentina, Chile, Paraguay

Contacts ^ICMJE

Julia Velonjara, MPH-julialv@uw.edu

Monica Vavilala, MD-vavilala@uw.edu

Responsible Party

Monica Vavilala, University of Washington

Funding Support ^ICMJE

National Institute of Neurological Disorders and Stroke, National Institutes of Health

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

• Children's National Research Institute

• Centro de Informática e Investigación Clínica (CIIC)

• Washington State University

• National Institute of Neurological Disorders and Stroke