TraceBook: the Clinical Proof of Concept on the Intensive Care.
- Conditions
- Safety IssuesCritical Illness
- Interventions
- Other: TraceBook
- Registration Number
- NCT03599856
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 408
- Physicians working on the ICU
- All admitted patients on the ICU during the study periods.
- Physicians objecting participation in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description "After" Intervention group TraceBook An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.
- Primary Outcome Measures
Name Time Method Checked items 24 hours (each day) The percentage of daily checked checkable items overall and items requiring an intervention per patient.
- Secondary Outcome Measures
Name Time Method Mortality 9 months 90 day mortality
Pharmacists' interventions 4 months Types of pharmacists' interventions based on the daily intensive care medication alerts
Incorrect prescribed proton pump inhibitors 4 months Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.
Opiates use 4 months Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (\<4).
User experience 6 months Semi-structured interview after the intervention period.
Ventilator days 9 months Number of days with use of mechanical ventilator (per patient and overall per period)
Sedation days 9 months Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.
Number of gastro-intestinal bleedings 4 months The number of patients during each period with hematemesis or melena, not being the reason of admission.
Incorrect prescribed anticoagulation or thrombosis prophylaxis. 4 months Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.
Central-venous-catheter-related bloodstream infections. 4 months The number of patients during each period with central-venous-catheter-related bloodstream infections, not being the reason of admission.
Spontaneous breathing trials 4 months Number of spontaneous breathing trials when required based on local protocol in weaning patients
Sedation wake up calls 4 months Number of sedation wake up calls when required based on local protocol
Antibiotics use 4 months Number of patient days with the use of antibiotics overall and when not required based on local protocol.
Complication registration 4 months Number of complications that were discussed within 24hrs and registered.
Length of stay 9 months Length of stay at the intensive care
Daily intensive care medication alerts 4 months Number of daily intensive care medication alerts for the pharmacist.
Ventilator and hospital associated pneumonia on the intensive care. 4 months The number of patients during each period with ventilator and hospital associated pneumonia, not being the reason of admission.
Incorrect prescribed selective digestive decontamination 4 months Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.
Energy deficit 4 months Number of patient days with energy deficit of \>250.
User acceptance 6 months 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.
Hedonic and pragmatic quality 6 months Attrakdiff questionnaire
Intravenous sedatives use 4 months Number of patient days with the use of intravenous sedatives (eg Propofol, Midazolam)
Automatically checked items 4 months Number of items that where or could have been checked automatically during each period.
User experience outcomes 6 months Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview
Trial Locations
- Locations (1)
Catharina Hospital
🇳🇱Eindhoven, Noord-Brabant, Netherlands