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

IntroductionDaily 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 D...

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Published in:	BMJ open Vol. 11; no. 6; p. e042302
Main Authors:	Noritomi, Danilo Teixeira, Ranzani, Otavio T, Ferraz, Leonardo Jose Rolim, dos Santos, Maura C, Cordioli, Eduardo, Albaladejo, Renata, Serpa Neto, Ary, Correa, Thiago D, Berwanger, Otávio, de Morais, Lubia Caus, Schettino, Guilherme, Cavalcanti, Alexandre Biasi, Rosa, Regis Goulart, Biondi, Rodrigo Santos, Salluh, Jorge IF, Azevedo, Luciano Cesar Pontes, Pereira, Adriano Jose
Format:	Journal Article
Language:	English
Published:	London BMJ Publishing Group LTD 21-06-2021 BMJ Publishing Group
Series:	Protocol
Subjects:	Anesthesia Business metrics Catheters Chronic illnesses Clinical outcomes Clinical trials Critical care Feedback Hospitals Intensive Care Intervention Length of stay Mortality Multidisciplinary teams Patient-centered care Patients Performance evaluation Physicians Telemedicine Telescopes Vital signs Brazil
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Summary:	IntroductionDaily 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 analysisA 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 disseminationThe 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 numberNCT03920501; Pre-results.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2020-042302