ArticleTrials2022
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.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03896789 (Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury
Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
- Article
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsAs 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 registrationPediatric Guideline Adherence and Outcomes-Argentina. Registered with ClinicalTrials.gov Identifier NCT03896789 on April 1, 2019.
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