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

BackgroundThe 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. ObjectiveTo 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. MethodsThe 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. ConclusionWe 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 REGISTRATIONClinicaltrials NCT05960994, Brazilian Registry of Clinical Trials RBR-342wxn9, and Universal Trial Number U1111-1298-9799.