TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil. Issue 6 (21st June 2021)

• Record Type: Journal Article
• 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
• Other Names: author non-byline.; Pereira Adriano José author non-byline.; Noritomi Danilo Teixeira author non-byline.; Ranzani Otavio Tavares author non-byline.; Santos Maura author non-byline.; Cavalcanti Alexandre Biasi author non-byline.; Neto Ary Serpa author non-byline.; Cordioli Eduardo author non-byline.; Gatti Fernando author non-byline.; Salluh Jorge author non-byline.; Ferraz Leonardo JR author non-byline.; Caus Lúbia author non-byline.; Azevedo Luciano author non-byline.; Santos Maura Cristina author non-byline.; Berwanger Otávio author non-byline.; Rosa Regis Goulart author non-byline.; Albaladejo Renata author non-byline.; Biondi Rodrigo author non-byline.; Correa Thiago Domingos author non-byline.
• Is Part Of: BMJ open. Volume 11:Issue 6(2021)
• Publication Date: 2021-06-21
• Subjects: telemedicine -- quality in health care -- intensive & critical care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-042302
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .