Statistical analysis plan for a stepped-wedge cluster randomized clinical trial for the evaluation of the clinical impact of different telemedicine practices in intensive care units - TELESCOPE 2 trial.

@article{santos2026statistical,
  title = {{Statistical analysis plan for a stepped-wedge cluster randomized clinical trial for the evaluation of the clinical impact of different telemedicine practices in intensive care units - TELESCOPE 2 trial.}},
  author = {Tiago Mendonça Dos Santos and Renato Carneiro de Freitas Chaves and Bruna Gomes Barbeiro and Maura Cristina Dos Santos and Thiago Domingos Corrêa and Alexandre Biasi Cavalcanti and Ary Serpa Neto and Carlos Henrique Sartorato Pedrotti and Fernando Godinho Zampieri and Guilherme de Paula Pinto Schettino and Jorge Ibrain Figueira Salluh and Leandro Utino Taniguchi and Leonardo José Rolim Ferraz and Luciano Cesar Pontes Azevedo and Otávio Berwanger and Regis Goulart Rosa and Renata Albaladejo Morbeck and Rodrigo Santos Biondi and Suzana Margareth Lobo and Jessica Kasza and Adriano José Pereira and Otavio Ranzani},
  journal = {Critical care science},
  year = {2026},
  month = oct,
  doi = {10.62675/2965-2774.20260013},
  url = {https://europepmc.org/article/MED/42912019},
  note = {CC BY},
}

TY  - JOUR
TI  - Statistical analysis plan for a stepped-wedge cluster randomized clinical trial for the evaluation of the clinical impact of different telemedicine practices in intensive care units - TELESCOPE 2 trial.
AU  - Tiago Mendonça Dos Santos
AU  - Renato Carneiro de Freitas Chaves
AU  - Bruna Gomes Barbeiro
AU  - Maura Cristina Dos Santos
AU  - Thiago Domingos Corrêa
AU  - Alexandre Biasi Cavalcanti
AU  - Ary Serpa Neto
AU  - Carlos Henrique Sartorato Pedrotti
AU  - Fernando Godinho Zampieri
AU  - Guilherme de Paula Pinto Schettino
AU  - Jorge Ibrain Figueira Salluh
AU  - Leandro Utino Taniguchi
AU  - Leonardo José Rolim Ferraz
AU  - Luciano Cesar Pontes Azevedo
AU  - Otávio Berwanger
AU  - Regis Goulart Rosa
AU  - Renata Albaladejo Morbeck
AU  - Rodrigo Santos Biondi
AU  - Suzana Margareth Lobo
AU  - Jessica Kasza
AU  - Adriano José Pereira
AU  - Otavio Ranzani
PY  - 2026
DA  - 2026/10/16
JO  - Critical care science
DO  - 10.62675/2965-2774.20260013
UR  - https://europepmc.org/article/MED/42912019
AB  - Background  The optimal model for delivering Tele-ICU is still to be determined. In the TELE-critical Care verSus usual Care on ICU Performance (TELESCOPE) trial, implementing medical-led daily multidisciplinary rounds did not show evidence of improved clinical outcomes. The TELESCOPE 2 trial was therefore designed to evaluate whether expanding this model to include a structured multidisciplinary care bundle, along with a formalized quality and safety management framework, would translate process improvements into measurable patient-centered outcome benefits.Objective  To evaluate whether a structured Tele-ICU intervention, comprising intensivist-led daily multidisciplinary rounds, a multidisciplinary care bundle (nursing, physical therapy, pharmacy), and a quality and safety management package, can reduce intensive care unit length of stay in Brazilian public intensive care units.Methods  TELESCOPE 2 is a multicenter, open-label, stepped-wedge cluster randomized trial including 25 intensive care units in Brazil from January 2024 to January 2026. Intensive care units are randomized to five sequences, receiving the intervention at staggered times. All adult patients admitted to participating units are eligible, except those admitted for non-medical reasons or those previously included in the study. The multifaceted telemedicine intervention comprises: i) daily multidisciplinary rounds led by board-certified intensivists; ii) coordinated care by a multidisciplinary team; and iii) a management strategy focused on quality improvement and patient safety. The primary outcome is intensive care unit length of stay. Secondary outcomes include clinical endpoints (mortality, ventilator-free days at 28 days, and ventilator-associated events), process-of-care indicators (mobilization, head-of-bed elevation, and sedation management), and unit-level organizational outcomes.Conclusion  We describe the statistical analysis plan for the TELESCOPE 2 trial, finalized prior to database lock. This pre-specified approach mitigates analysis bias and ensures the transparency and robustness of the reported results.
SN  - 2965-2774
ER  -