Clinical trial NCT03599856: TraceBook: the Clinical Proof of Concept on the Intensive Care.
Official title: TraceBook: the Clinical Proof of Concept on the Intensive Care.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Safety Issues
Keywords: Checklist
Intensive Care Unit
Clinical decision support systems
Medical errors
Patient safety
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2018-07-26
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Checked items
timeFrame: 24 hours (each day)
Secondary outcomes:
measure: Mortality
timeFrame: 9 months
measure: Mortality
timeFrame: 9 months
measure: Mortality
timeFrame: 9 months
measure: Length of stay
timeFrame: 9 months
measure: Ventilator days
timeFrame: 9 months
measure: Sedation days
timeFrame: 9 months
measure: Daily intensive care medication alerts
timeFrame: 4 months
measure: Pharmacists' interventions
timeFrame: 4 months
measure: Number of gastro-intestinal bleedings
timeFrame: 4 months
measure: Ventilator and hospital associated pneumonia on the intensive care.
timeFrame: 4 months
measure: Central-venous-catheter-related bloodstream infections.
timeFrame: 4 months
measure: Incorrect prescribed anticoagulation or thrombosis prophylaxis.
timeFrame: 4 months
measure: Incorrect prescribed proton pump inhibitors
timeFrame: 4 months
measure: Incorrect prescribed selective digestive decontamination
timeFrame: 4 months
measure: Spontaneous breathing trials
timeFrame: 4 months
measure: Sedation wake up calls
timeFrame: 4 months
measure: Intravenous sedatives use
timeFrame: 4 months
measure: Opiates use
timeFrame: 4 months
measure: Antibiotics use
timeFrame: 4 months
measure: Complication registration
timeFrame: 4 months
measure: Energy deficit
timeFrame: 4 months
measure: Automatically checked items
timeFrame: 4 months
measure: User experience outcomes
timeFrame: 6 months
measure: Hedonic and pragmatic quality
timeFrame: 6 months
measure: User acceptance
timeFrame: 6 months
measure: User experience
timeFrame: 6 months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Erik Korsten, Prof MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.