Evaluation of the clinical impact of different telemedicine practices in intensive care units: A stepped-wedge cluster randomized clinical trial (TELESCOPE 2): Study protocol

Background The safety and feasibility of telemedicine in intensive care units (ICU) are well established. However, whether tele-ICU exerts a measurable impact on clinically relevant outcomes remains uncertain. Objective To evaluate whether a multifaceted Tele-ICU intervention, integrating intensivist-led daily multidisciplinary rounds (DMRs), coordinated care from a multidisciplinary team, and a quality and safety management strategy focused on quality improvement can reduce ICU length of stay among patients in Brazil. Design, setting, participants, and intervention: The TELESCOPE 2 study is a multicentre, 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 will be randomized and allocated to one of five sequences. All ICUs will receive the interventions in a staggered manner at different times. All adult patients admitted in participant ICUs will be eligible for inclusion in the study. Admissions to the ICU due to justice-related issues (since in such circumstances the ICU admission or discharge may be determined by the law rather than by medical reasons), and patients previously included in the TELESCOPE 2 study will be excluded. The trial intervention is multifaceted, comprising three components delivered in combination, via telemedicine: I) daily multidisciplinary rounds led by board-certified intensive care physicians; II) coordinated care by a multidisciplinary team, including nurses, physiotherapists, and clinical pharmacists); III) a management strategy focused on quality improvement and patient safety. Main outcome measures The primary outcome is ICU length of stay. Secondary outcomes include ICU mortality, in-hospital mortality, ventilator-free days during the first 28 days, ICU readmission within 48 h, early reintubation, ventilator-associated events, and accidental extubation rate. Results The TELESCOPE 2 study will assess whether a muiltifaceted Tele-ICU intervention can reduce ICU lenght of stay among critically ill patients in Brazil. Conclusion We describe the study protocol for the TELESCOPE 2 trial, finalized prior to database lock. TELESCOPE 2 will evaluate the clinical impact of a structured Tele-ICU intervention in resource-variable ICUs and may provide robust evidence regarding the optimal model for delivering Tele-ICU.