Algorithmic surveillance of ICU patients with acute respiratory distress syndrome (ASIC): protocol for a multicentre stepped-wedge cluster randomised quality improvement strategy

TY - JOUR

T1 - Algorithmic surveillance of ICU patients with acute respiratory distress syndrome (ASIC): protocol for a multicentre stepped-wedge cluster randomised quality improvement strategy

AU - Marx, Gernot

AU - Bickenbach, Johannes

AU - Fritsch, Sebastian Johannes

AU - Kunze, Julian Benedict

AU - Maassen, Oliver

AU - Deffge, Saskia

AU - Kistermann, Jennifer

AU - Haferkamp, Silke

AU - Lutz, Irina

AU - Voellm, Nora Kristiana

AU - Lowitsch, Volker

AU - Polzin, Richard

AU - Sharafutdinov, Konstantin

AU - Mayer, Hannah

AU - Kuepfer, Lars

AU - Burghaus, Rolf

AU - Schmitt, Walter

AU - Lippert, Joerg

AU - Riedel, Morris

AU - Barakat, Chadi

AU - Stollenwerk, André

AU - Fonck, Simon

AU - Putensen, Christian

AU - Zenker, Sven

AU - Erdfelder, Felix

AU - Grigutsch, Daniel

AU - Kram, Rainer

AU - Beyer, Susanne

AU - Kampe, Knut

AU - Gewehr, Jan Erik

AU - Salman, Friederike

AU - Juers, Patrick

AU - Kluge, Stefan

AU - Tiller, Daniel

AU - Wisotzki, Emilia

AU - Gross, Sebastian

AU - Homeister, Lorenz

AU - Bloos, Frank

AU - Scherag, André

AU - Ammon, Danny

AU - Mueller, Susanne

AU - Palm, Julia

AU - Simon, Philipp

AU - Jahn, Nora

AU - Loeffler, Markus

AU - Wendt, Thomas

AU - Schuerholz, Tobias

AU - Groeber, Petra

AU - Schuppert, Andreas

PY - 2021/4/8

Y1 - 2021/4/8

N2 - INTRODUCTION: The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure.METHODS AND ANALYSIS: In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested.ETHICS AND DISSEMINATION: Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals.TRIAL REGISTRATION NUMBER: DRKS00014330.

AB - INTRODUCTION: The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure.METHODS AND ANALYSIS: In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested.ETHICS AND DISSEMINATION: Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals.TRIAL REGISTRATION NUMBER: DRKS00014330.

U2 - 10.1136/bmjopen-2020-045589

DO - 10.1136/bmjopen-2020-045589

M3 - SCORING: Journal article

C2 - 34550901

VL - 11

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 4

M1 - e045589

ER -