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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Safety Issues
• Intervention / Treatment: Other: TraceBook

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.

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: "Before" control group; 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)
Experimental: "After" Intervention group; An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.	Other: TraceBook; TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.; Other Names: Dynamic clinical checklist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checked items	The percentage of daily checked checkable items overall and items requiring an intervention per patient.	24 hours (each day)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Philips Electronics Nederland B.V. acting through Philips CTO organization; Eindhoven University of Technology
• Investigators: Study Director: Erik Korsten, Prof MD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2018
• Primary Completion (Anticipated): February 12, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Patient safety; Medical errors; Checklist; Clinical decision support systems
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: nWMO-2018.61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD is available if researchers ask for it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No