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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
408
TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Checked items
The percentage of daily checked checkable items overall and items requiring an intervention per patient.
Time frame: 24 hours (each day)
Mortality
Intensive Care mortality
Time frame: 9 months
Mortality
30 day mortality
Time frame: 9 months
Mortality
90 day mortality
Time frame: 9 months
Length of stay
Length of stay at the intensive care
Time frame: 9 months
Ventilator days
Number of days with use of mechanical ventilator (per patient and overall per period)
Time frame: 9 months
Sedation days
Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.
Time frame: 9 months
Daily intensive care medication alerts
Number of daily intensive care medication alerts for the pharmacist.
Time frame: 4 months
Pharmacists' interventions
Types of pharmacists' interventions based on the daily intensive care medication alerts
Time frame: 4 months
Number of gastro-intestinal bleedings
The number of patients during each period with hematemesis or melena, not being the reason of admission.
Time frame: 4 months
Ventilator and hospital associated pneumonia on the intensive care.
The number of patients during each period with ventilator and hospital associated pneumonia, not being the reason of admission.
Time frame: 4 months
Central-venous-catheter-related bloodstream infections.
The number of patients during each period with central-venous-catheter-related bloodstream infections, not being the reason of admission.
Time frame: 4 months
Incorrect prescribed anticoagulation or thrombosis prophylaxis.
Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.
Time frame: 4 months
Incorrect prescribed proton pump inhibitors
Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.
Time frame: 4 months
Incorrect prescribed selective digestive decontamination
Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.
Time frame: 4 months
Spontaneous breathing trials
Number of spontaneous breathing trials when required based on local protocol in weaning patients
Time frame: 4 months
Sedation wake up calls
Number of sedation wake up calls when required based on local protocol
Time frame: 4 months
Intravenous sedatives use
Number of patient days with the use of intravenous sedatives (eg Propofol, Midazolam)
Time frame: 4 months
Opiates use
Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (\<4).
Time frame: 4 months
Antibiotics use
Number of patient days with the use of antibiotics overall and when not required based on local protocol.
Time frame: 4 months
Complication registration
Number of complications that were discussed within 24hrs and registered.
Time frame: 4 months
Energy deficit
Number of patient days with energy deficit of \>250.
Time frame: 4 months
Automatically checked items
Number of items that where or could have been checked automatically during each period.
Time frame: 4 months
User experience outcomes
Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview
Time frame: 6 months
Hedonic and pragmatic quality
Attrakdiff questionnaire
Time frame: 6 months
User acceptance
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.
Time frame: 6 months
User experience
Semi-structured interview after the intervention period.
Time frame: 6 months
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