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 II trial

Abstract Background The optimal model for delivering Tele-ICU is still to be determined. Previous clinical trials focused on medical-led daily multidisciplinary rounds (DMRs), showing certain improvements in processes of care but without direct evidence for improvement in clinical outcomes. Objective To evaluate whether a structured Tele-ICU intervention, comprising DMRs led by an intensivist plus a multidisciplinary care bundle (nursing, physical therapy, pharmacy) and a quality and safety management package, can reduce ICU length of stay in Brazilian public ICUs. Methods The TELESCOPE 2 is a multicenter, open-label, stepped-wedge cluster randomized controlled trial including 25 ICUs in Brazil from January 2024 to January 2026. In a stepped-wedge assignment, ICUs are randomized and allocated into one of five sequences. All adult patients admitted in participant ICUs will be eligible for inclusion in the study. Admissions for non-medical reasons, and patients previously included in the TELESCOPE 2 study will be excluded. All ICUs will receive the interventions staggered at different times. The trial intervention is multifaceted, comprising three components delivered in combination via telemedicine: i) daily multidisciplinary rounds led by board-certified intensive care physician; ii) coordinated care by a multidisciplinary team, including nurses, physiotherapists, and clinical pharmacists; iii) a management strategy focused on quality improvement and patient safety. The primary outcome is ICU length of stay. Secondary outcomes include clinical endpoints (ICU mortality, ventilator-free days at 28 days, and ventilator-associated events), process-of-care indicators (e.g., mobilization density, head-of-bed elevation, and sedation management), and unit-level organizational outcomes based on standard resource use and standardized mortality rates. Conclusion We describe the statistical analysis plan for the TELESCOPE II trial, finalized prior to database lock. This pre-specified approach mitigates analysis bias and ensures the transparency and robustness of the reported results. TRIAL REGISTRATION Clinicaltrials NCT05960994 , Brazilian Registry of Clinical Trials RBR-342wxn9, and Universal Trial Number U1111-1298-9799.