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

Critical Illness Clinical Trial

— TraceBook  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03599856
• Other study ID #: nWMO-2018.61
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: June 1, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Eindhoven University of Technology, Philips Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Checked items	The percentage of daily checked checkable items overall and items requiring an intervention per patient.	24 hours (each day)
Secondary	Mortality	Intensive Care mortality	9 months
Secondary	Mortality	30 day mortality	9 months
Secondary	Mortality	90 day mortality	9 months
Secondary	Length of stay	Length of stay at the intensive care	9 months
Secondary	Ventilator days	Number of days with use of mechanical ventilator (per patient and overall per period)	9 months
Secondary	Sedation days	Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.	9 months
Secondary	Daily intensive care medication alerts	Number of daily intensive care medication alerts for the pharmacist.	4 months
Secondary	Pharmacists' interventions	Types of pharmacists' interventions based on the daily intensive care medication alerts	4 months
Secondary	Number of gastro-intestinal bleedings	The number of patients during each period with hematemesis or melena, not being the reason of admission.	4 months
Secondary	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.	4 months
Secondary	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.	4 months
Secondary	Incorrect prescribed anticoagulation or thrombosis prophylaxis.	Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.	4 months
Secondary	Incorrect prescribed proton pump inhibitors	Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.	4 months
Secondary	Incorrect prescribed selective digestive decontamination	Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.	4 months
Secondary	Spontaneous breathing trials	Number of spontaneous breathing trials when required based on local protocol in weaning patients	4 months
Secondary	Sedation wake up calls	Number of sedation wake up calls when required based on local protocol	4 months
Secondary	Intravenous sedatives use	Number of patient days with the use of intravenous sedatives (eg Propofol, Midazolam)	4 months
Secondary	Opiates use	Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (<4).	4 months
Secondary	Antibiotics use	Number of patient days with the use of antibiotics overall and when not required based on local protocol.	4 months
Secondary	Complication registration	Number of complications that were discussed within 24hrs and registered.	4 months
Secondary	Energy deficit	Number of patient days with energy deficit of >250.	4 months
Secondary	Automatically checked items	Number of items that where or could have been checked automatically during each period.	4 months
Secondary	User experience outcomes	Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview	6 months
Secondary	Hedonic and pragmatic quality	Attrakdiff questionnaire	6 months
Secondary	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.	6 months
Secondary	User experience	Semi-structured interview after the intervention period.	6 months