Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial
Abstract:Objective:
The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care.
Methods:
The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of dail… Show more
“…A cluster-randomised trial of TCC with a lower risk of bias will be available soon. 27 The only randomised trial of TCC of which we are aware found effects on protocol adherence but not patient outcomes. 5 Importantly, because of the (nearly) patient level randomisation and contamination from shared clinicians, our analysis of TECTONICS does not capture benefits to outcomes due to overall improvements in protocol adherence, discussed below.…”
Background: Novel applications of telemedicine can improve care quality and patient outcomes. Telemedicine for intraoperative decision support has not been rigorously studied. Methods: This single centre randomised clinical trial (clinicaltrials.govNCT03923699) of unselected adult surgical patients was conducted between July 1, 2019 and January 31, 2023. Patients received usual care or decision support from a telemedicine service, the Anesthesiology Control Tower (ACT). The ACT provided real-time recommendations to intraoperative anaesthesia clinicians based on case reviews, machine-learning forecasting, and physiologic alerts. ORs were randomised 1:1. Co-primary outcomes of 30-day all-cause mortality, respiratory failure, acute kidney injury (AKI), and delirium were analysed as intention-to-treat. Results: The trial completed planned enrolment with 71927 surgeries (35956 ACT; 35971 usual care). After multiple testing correction, there was no significant effect of the ACT vs. usual care on 30-day mortality [641/35956 (1.8%) vs 638/35971 (1.8%), risk difference 0.0% (95% CI -0.2% to 0.3%), p=0.96], respiratory failure [1089/34613 (3.1%) vs 1112/34619 (3.2%), risk difference -0.1% (95% CI -0.4% to 0.3%), p=0.96], AKI [2357/33897 (7%) vs 2391/33795 (7.1%), risk difference -0.1% (-0.6% to 0.4%), p=0.96], or delirium [1283/3928 (32.7%) vs 1279/3989 (32.1%), risk difference 0.6% (-2.0% to 3.2%), p=0.96]. There were no significant differences in secondary outcomes or in sensitivity analyses. Conclusions: In this large RCT of a novel application of telemedicine-based remote monitoring and decision support using real-time alerts and case reviews, we found no significant differences in postoperative outcomes. Large-scale intraoperative telemedicine is feasible, and we suggest future avenues where it may be impactful.
“…A cluster-randomised trial of TCC with a lower risk of bias will be available soon. 27 The only randomised trial of TCC of which we are aware found effects on protocol adherence but not patient outcomes. 5 Importantly, because of the (nearly) patient level randomisation and contamination from shared clinicians, our analysis of TECTONICS does not capture benefits to outcomes due to overall improvements in protocol adherence, discussed below.…”
Background: Novel applications of telemedicine can improve care quality and patient outcomes. Telemedicine for intraoperative decision support has not been rigorously studied. Methods: This single centre randomised clinical trial (clinicaltrials.govNCT03923699) of unselected adult surgical patients was conducted between July 1, 2019 and January 31, 2023. Patients received usual care or decision support from a telemedicine service, the Anesthesiology Control Tower (ACT). The ACT provided real-time recommendations to intraoperative anaesthesia clinicians based on case reviews, machine-learning forecasting, and physiologic alerts. ORs were randomised 1:1. Co-primary outcomes of 30-day all-cause mortality, respiratory failure, acute kidney injury (AKI), and delirium were analysed as intention-to-treat. Results: The trial completed planned enrolment with 71927 surgeries (35956 ACT; 35971 usual care). After multiple testing correction, there was no significant effect of the ACT vs. usual care on 30-day mortality [641/35956 (1.8%) vs 638/35971 (1.8%), risk difference 0.0% (95% CI -0.2% to 0.3%), p=0.96], respiratory failure [1089/34613 (3.1%) vs 1112/34619 (3.2%), risk difference -0.1% (95% CI -0.4% to 0.3%), p=0.96], AKI [2357/33897 (7%) vs 2391/33795 (7.1%), risk difference -0.1% (-0.6% to 0.4%), p=0.96], or delirium [1283/3928 (32.7%) vs 1279/3989 (32.1%), risk difference 0.6% (-2.0% to 3.2%), p=0.96]. There were no significant differences in secondary outcomes or in sensitivity analyses. Conclusions: In this large RCT of a novel application of telemedicine-based remote monitoring and decision support using real-time alerts and case reviews, we found no significant differences in postoperative outcomes. Large-scale intraoperative telemedicine is feasible, and we suggest future avenues where it may be impactful.
The use of ventilator-free days (VFDs) as an outcome measure is increasingly popular in critical care research. (1)(2)(3) This composite outcome simultaneously reflects patient survival and the time not spent on mechanical ventilation (MV) within a specified timeframe, which usually extends from randomization up to Day 28. For patients who do not survive this period, VFDs are recorded as zero.Composite outcomes, such as those combining death, myocardial infarction, or stroke, are commonly used in fields such as cardiology due to their ability to enhance the statistical power of clinical trials while focusing on patient-relevant events.
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confidence: 99%
“…The use of ventilator-free days (VFDs) as an outcome measure is increasingly popular in critical care research. (1)(2)(3) This composite outcome simultaneously reflects patient survival and the time not spent on mechanical ventilation (MV) within a specified timeframe, which usually extends from randomization up to Day 28. For patients who do not survive this period, VFDs are recorded as zero.…”
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