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
Year: 2026
Type: article
Study design: Study Protocol
Abstract: 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.
Source: Critical Care Science
Authors: Tiago Mendonça dos Santos, Renato Carneiro de Freitas Chaves, Bruna Gomes Barbeiro, Maura Cristina dos Santos, Thiago Domingos Corrêa, Alexandre Biasi Cavalcanti, Ary Serpa, Carlos Henrique Sartorato Pedrotti, Fernando Godinho Zampieri, Guilherme de Paula Pinto Schettino, Jorge Ibrain Figueira Salluh, Leandro Utino Taniguchi, Leonardo José Rolim Ferraz, Luciano Cesar Pontes Azevedo, Otávio Berwanger, Regis Goulart Rosa, Renata Albaladejo Morbeck, Rodrigo Santos Biondi, Suzana Margareth Lobo, Jessica Kasza, Adriano José Pereira, Otavio Ranzani
Institutions: Hospital Israelita Albert Einstein, Insper, Hospital Santa Luzia, Massachusetts Institute of Technology, Hospital do Coração, Monash University, Brazilian Research in Intensive Care Network, Universidade Federal do Rio de Janeiro, Universidade de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Hospital Sírio-Libanês, Hospital Moinhos de Vento, Hospital de Base, Institut de Recerca Sant Pau
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7221096626