Trial reportCritical care science2026
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.
Trial report in Critical care science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
22 authors.
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Abstract
backgroundThe 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.
objectiveTo 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.
methodsTELESCOPE 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.
conclusionWe 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.
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