TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil

Danilo Teixeira Noritomi, Otavio T Ranzani, Leonardo Jose Rolim Ferraz, Maura C Dos Santos, Eduardo Cordioli, Renata Albaladejo, Ary Serpa Neto, Thiago D Correa, Otávio Berwanger, Lubia Caus de Morais, Guilherme Schettino, Alexandre Biasi Cavalcanti, Regis Goulart Rosa, Rodrigo Santos Biondi, Jorge If Salluh, Luciano Cesar Pontes Azevedo, Adriano Jose Pereira, TELESCOPE Trial Investigators, Adriano José Pereira, Danilo Teixeira Noritomi, Otavio Tavares Ranzani, Maura Santos, Alexandre Biasi Cavalcanti, Ary Serpa Neto, Eduardo Cordioli, Fernando Gatti, Jorge Salluh, Leonardo Jr Ferraz, Lúbia Caus, Luciano Azevedo, Maura Cristina Santos, Otávio Berwanger, Regis Goulart Rosa, Renata Albaladejo, Rodrigo Biondi, Thiago Domingos Correa, Danilo Teixeira Noritomi, Otavio T Ranzani, Leonardo Jose Rolim Ferraz, Maura C Dos Santos, Eduardo Cordioli, Renata Albaladejo, Ary Serpa Neto, Thiago D Correa, Otávio Berwanger, Lubia Caus de Morais, Guilherme Schettino, Alexandre Biasi Cavalcanti, Regis Goulart Rosa, Rodrigo Santos Biondi, Jorge If Salluh, Luciano Cesar Pontes Azevedo, Adriano Jose Pereira, TELESCOPE Trial Investigators, Adriano José Pereira, Danilo Teixeira Noritomi, Otavio Tavares Ranzani, Maura Santos, Alexandre Biasi Cavalcanti, Ary Serpa Neto, Eduardo Cordioli, Fernando Gatti, Jorge Salluh, Leonardo Jr Ferraz, Lúbia Caus, Luciano Azevedo, Maura Cristina Santos, Otávio Berwanger, Regis Goulart Rosa, Renata Albaladejo, Rodrigo Biondi, Thiago Domingos Correa

Abstract

Introduction: Daily multidisciplinary rounds (DMRs) consist of systematic patient-centred discussions aiming to establish joint therapeutic goals for the next 24 hours of intensive care unit (ICU) care. The aim of the present study protocol is to evaluate whether an intervention consisting of guided DMRs, supported by a remote specialist and audit/feedback on care performance will reduce ICU length of stay compared with a control group.

Methods and analysis: A multicentre, controlled, cluster-randomised superiority trial including 30 ICUs in Brazil (15 intervention and 15 control), from August 2019 to June 2021. In a parallel assignment, ICUs are randomised to a complex-intervention composed by daily rounds carried out through Tele-ICU by a remote ICU physician; development of local quality indicators dashboards coupled with monthly meetings with local leadership; and dissemination of evidence-based clinical protocols versus usual care. Primary outcome is ICU length of stay. Secondary outcomes include classification of the unit according to the profiles defined by the standardised resource use and the standardised mortality rate, hospital mortality, incidence of healthcare-associated infections, ventilator-free days at 28 days, patient-days receiving oral or enteral feeding, patient-days under light sedation or alert and calm, rate of patients under normoxaemia. All adult patients admitted after the beginning of the study in each participant ICU will be enrolled. Inclusion criteria (clusters): public Brazilian ICUs with a minimum of 8 ICU beds interested/committed to participating in the study. Exclusion criteria (clusters): units with fully established DMRs by an intensivist, specialised or step-down units.

Ethics and dissemination: The study protocol was approved by the institutional review board (IRB) of the coordinator centre, and by IRBs of each enrolled hospital/ICU. Statistical analysis protocol is being prepared for submission before the end of patient's enrolment. Results will be disseminated through conferences, peer-reviewed journals and to each participating unit.

Trial registration number: NCT03920501; Pre-results.

Keywords: intensive & critical care; quality in health care; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Geographical distribution of the 30 intensive care units in Brazil participating in the TELE-critical Care verSus usual Care On ICU PErformance trial.
Figure 2
Figure 2
Trial timeline, randomisation, intervention and follow-up. ICU, intensive care unit; IRB, institutional review board.
Figure 3
Figure 3
Illustration of the multicomponent training of board-certified intensivists to act in the intervention arm. ICU, intensive care unit; IHI, institute for healthcare improvement.

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