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
Author:
Velonjara JuliaORCID, Mills Brianna, Lujan Silvia, Petroni Gustavo, Bell Michael J., Guadagnoli Nahuel, Mock Charles, Hughes James P., Vavilala Monica S., Rowhani-Rahbar Ali, Alassia Mariela, Abalos Silvina, Gómez Arriola Natalia, Castellani Pablo, Chuchuy Sandra, Cinquegrani Karina, Dávila Carlos, Diettes Adriana, López Cruz Gabriela, Mansur Alejandro, Marinelli Ivana, Medici Paula, Oliveri Silvia, Penazzi Matías, Romero Graciela, Segado Ariel, Depetris Alejandra, Giordano Daniel, Boyle Linda Ng, Moore Megan, Weiner Bryan, Segar Karen, Wang Jin, Deshpande Shyam J., Hicks Chelsea, Graves Janessa,
Abstract
Abstract
Background
The aim of this protocol is to describe the study protocol changes made and subsequently implemented to the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT) for care of children with severe traumatic brain injuries (TBI) imposed by the COVID-19 pandemic. The PEGASUS study group met in spring 2020 to evaluate available literature review guidance and the study design change or pausing options due to the potential interruption of research.
Methods
As a parallel cluster RCT, pediatric patients with severe TBIs are admitted to 8 control (usual care) and 8 intervention (PEGASUS program) hospitals in Argentina, Chile, and Paraguay. PEGASUS is an intervention that aims to increase guideline adherence and best practice care for improving patient outcomes using multi-level implementation science-based approaches. Strengths and weaknesses of proposed options were assessed and resulted in a decision to revert from a stepped wedge to a parallel cluster RCT but to not delay planned implementation.
Discussion
The parallel cluster design was considered more robust and flexible to secular interruptions and acceptable and feasible to the local study sites in this situation. Due to the early stage of the study, the team had flexibility to redesign and implement a design more compatible with the conditions of the research landscape in 2020 while balancing analytical methods and power, logistical and implementation feasibility, and acceptability. As of fall 2022, the PEGASUS RCT has been active for nearly 2 years of implementation and data collection, scheduled to be completed in in fall 2023. The experience of navigating research during this period will influence decisions about future research design, strategies, and contingencies.
Trial registration
Pediatric Guideline Adherence and Outcomes-Argentina. Registered with ClinicalTrials.gov Identifier NCT03896789 on April 1, 2019.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference24 articles.
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