Pediatric Guideline Adherence and Outcomes- Argentina

NCT ID: NCT03896789

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2023-12-31

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care, then Usual Care (Control)

All sites will collect usual care data during the baseline and post-randomization study periods. 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual Care, then PEGASUS Program (Intervention)

All sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care.

Group Type: EXPERIMENTAL

PEGASUS Program for Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Centro de Informática e Investigación Clínica (CIIC)

UNKNOWN

Sponsor Role: collaborator

Washington State University

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Monica Vavilala

Professor, School of Medicine: Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Vavilala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Hospital Sor Ludovica

La Plata, Buenos Aires, Argentina

Hospital Interzonal Especializado Materno Infantil

Mar del Plata, Buenos Aires, Argentina

Hospital el Cruce

San Juan Bautista, Buenos Aires, Argentina

Hospital Municipal del Nino de San Justo

San Justo, Buenos Aires, Argentina

Hospital de Ninos Eva Peron

Catamarca, Catamarca Province, Argentina

Hospital Materno Infantil Dr. Hector Quintana

San Salvador de Jujuy, Jujuy Province, Argentina

Hospital Regional Reconquista

Reconquista, Santa Fe Province, Argentina

Hopital Victor J. Vilela

Rosario, Santa Fe Province, Argentina

Hospital del Nino Jesus

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital de La Santisima Trinidad

Córdoba, , Argentina

Hospital Humberto Notti

Mendoza, , Argentina

Hospital Publico Materno Infantil

Salta, , Argentina

Hospital Alassia

Santa Fe, , Argentina

Centro Provincial de Salud Infantil Eva Peron

Santiago del Estero, , Argentina

Hospital Carlos Van Buren

Valparaíso, , Chile

Hospital de Trauma Manuel Giagni

Asunción, , Paraguay

Countries

Argentina; Chile; Paraguay

References

Velonjara J, Mills B, Lujan S, Petroni G, Bell MJ, Guadagnoli N, Mock C, Hughes JP, Vavilala MS, Rowhani-Rahbar A; PEGASUS Argentina Study Group. The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial. Trials. 2022 Dec 5;23(1):980. doi: 10.1186/s13063-022-06938-x.

Reference Type: DERIVED

PMID: 36471399 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NS106560-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005629

Identifier Type: -

Identifier Source: org_study_id