TraceBook: the Clinical Proof of Concept on the Intensive Care. (TraceBook)

Eindhoven University of Technology, Philips Electronics Nederland B.V. acting through Philips CTO organization

The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. The proof of concept of this dynamic clinical checklist (DCC; BJA 2017 (DOI: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. The purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (ICU) ward.

Method A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study. The before period will be used as control group in which ward rounds and nurse handovers will be observed by the investigators for two months. Then TraceBook will be introduced and clinicians, ICU doctors and nurses, will be able to use checklists of TraceBook for ward rounds, their shifts and handovers in which they will be observed for two months. The goal is at least 120 observations per period. Endpoints The primary outcome is the percentage of items that were checked per ward rounds and nurse handovers during the before and the after implementation period. Secondary outcomes will be clinical outcomes of admitted patients, pharmacist specific outcomes, specific checkable item related outcomes, and user experience and acceptance scores. Hypothesis TraceBook, with the use of digital dynamic checklists, improves compliance to care processes on the intensive care with a high user acceptance score.

Control group with observation of current local standard of care with paper checklist available at the bedside during the ICU rounds of the ICU physicians (as usual)

An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.

TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.

The percentage of daily checked checkable items overall and items requiring an intervention per patient.

Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.

The number of patients during each period with hematemesis or melena, not being the reason of admission.

The number of patients during each period with ventilator and hospital associated pneumonia, not being the reason of admission.

The number of patients during each period with central-venous-catheter-related bloodstream infections, not being the reason of admission.

Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.

Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.

Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.

Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (<4).

Number of patient days with the use of antibiotics overall and when not required based on local protocol.

Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview

Technology Acceptance Model 2 (TAM2) based questionnaire after both periods to compare paper checklist and electronic health records with digital checklist and electronic health records.

Inclusion Criteria: Physicians working on the ICU All admitted patients on the ICU during the study periods. Exclusion Criteria: Physicians objecting participation in the trial

De Bie AJR, Nan S, Vermeulen LRE, Van Gorp PME, Bouwman RA, Bindels AJGH, Korsten HHM. Intelligent dynamic clinical checklists improved checklist compliance in the intensive care unit. Br J Anaesth. 2017 Aug 1;119(2):231-238. doi: 10.1093/bja/aex129.

De Bie AJR, Mestrom E, Compagner W, Nan S, van Genugten L, Dellimore K, Eerden J, van Leeuwen S, van de Pol H, Schuling F, Lu X, Bindels AJGH, Bouwman ARA, Korsten EHHM. Intelligent checklists improve checklist compliance in the intensive care unit: a prospective before-and-after mixed-method study. Br J Anaesth. 2021 Feb;126(2):404-414. doi: 10.1016/j.bja.2020.09.044. Epub 2020 Nov 17.