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

Autor: Noritomi DT; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil dnoritomi@hotmail.com.; Clinical Governance, DASA, Sao Paulo, Brazil.; Telemedicine, Hospital Israelita Albert Einstein, São Paulo, Brazil., Ranzani OT; Pulmonary Division, Heart Institute, Hospital das Clinicas, Universidade de Sao Paulo Faculdade de Medicina Hospital das Clinicas, Sao Paulo, SP, Brazil.; ISGlobal, Barcelona Institute for Global Health, Barcelona, Catalunya, Spain., Ferraz LJR; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil., Dos Santos MC; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.; Telemedicine, Hospital Israelita Albert Einstein, São Paulo, Brazil., Cordioli E; Telemedicine, Hospital Israelita Albert Einstein, São Paulo, Brazil., Albaladejo R; Telemedicine, Hospital Israelita Albert Einstein, São Paulo, Brazil., Serpa Neto A; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil., Correa TD; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil., Berwanger O; Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo, São Paulo, Brazil., de Morais LC; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil., Schettino G; Institute of Social Responsibility, Hospital Israelita Albert Einstein, Sao Paulo, Brazil., Cavalcanti AB; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil.; HCor Research Institute, Sao Paulo, SP, Brazil., Rosa RG; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil.; Intensive Care, HMV, Porto Alegre, Rio Grande do Sul, Brazil., Biondi RS; Instituto de Cardiologia do Distrito Federal, Brasília, Distrito Federal, Brazil.; Hospital Brasília, Brasília, DF, Brazil., Salluh JI; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil.; Department of Critical Care and Graduate Program in Translational Medicine, D'Or Institute for Research and Education, Rio de Janeiro, Brazil, Rio de Janeiro, Brazil., Azevedo LCP; Brazilian Research in Intensive Care Network - BRICNET, São Paulo, SP, Brazil.; Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, SP, Brazil.; Emergency Medicine Department, University of Sao Paulo, Sao Paulo, São Paulo, Brazil., Pereira AJ; Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.; Telemedicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.; Postgraduate Program of Health Sciences, Universidade Federal de Lavras, Lavras, MG, Brazil.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2021 Jun 21; Vol. 11 (6), pp. e042302. Date of Electronic Publication: 2021 Jun 21.
DOI: 10.1136/bmjopen-2020-042302
Abstrakt: 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.
Competing Interests: 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.)
Databáze: MEDLINE