TraceBook: the Clinical Proof of Concept on the Intensive Care.
Phase: NA
Conditions: Critical Illness, Safety Issues
Sponsor: Catharina Ziekenhuis Eindhoven

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
1 
 
TraceBook: the clinical proof of concept on the 
intensive care. 
 
Ashley De Bie M.D.1, Dr. A. J. G. H. Bindels1, Dr. R.A. Bouwman2, Prof. Dr. H.H.M. Korsten2.  
 
1 Department of Internal Medicine, Division of Intensive Care, Catharina Hospital Eindhoven, the 
Netherlands 
2 Department of Anesthesiology, Division of Intensive Care, Catharina Hospital Eindhoven, the 
Netherlands 
 
Correspondence to: 
Ashley De Bie, 
Address: 
Department of Internal Medicine,  
Division of Intensive Care Medicine,  
Catharina Hospital Eindhoven, 5623 EJ Eindhoven. 
 
Email: ashley.d.bie@catharinaziekenhuis.nl 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
2 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of the authors. No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written 
authorization from the authors. 
 
 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
3 
 
 
Protocol ID 
 
 
 
 
Short title                                  
TraceBook: clinical proof of concept ICU. 
 
Version                                  
1.0 
 
 
Date                                          
01-03-2018 
 
Coordinating investigators     
 
 
AJR De Bie Dekker MD,  
Department of Internal Medicine,  
Division of Intensive Care Medicine,  
Catharina Hospital Eindhoven, 
5623 EJ, Eindhoven, the Netherlands. 
 
 
 
       
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
4 
 
Content  
Signatures....................................................................... Fout! Bladwijzer niet gedefinieerd. 
Content ............................................................................................................................ 4 
Summary .......................................................................................................................... 6 
Background .............................................................................................................................................. 6 
Method .................................................................................................................................................... 6 
Endpoints ................................................................................................................................................. 6 
Hypothesis ............................................................................................................................................... 6 
1. Background and Rationale............................................................................................. 7 
2. Aim & study endpoints ................................................................................................ 10 
2.1 Goal/hypothesis .............................................................................................................................. 10 
2.2 Primary endpoint ............................................................................................................................. 10 
2.3 Secondary endpoints ....................................................................................................................... 10 
3. Study design ............................................................................................................... 12 
3.1 Design .............................................................................................................................................. 12 
3.2 Setting .............................................................................................................................................. 12 
4. Research participants .................................................................................................. 13 
4.1 Participants ...................................................................................................................................... 13 
4.2 Recruitment of participants ............................................................................................................ 13 
4.3 Sample size calculation .................................................................................................................... 13 
5. Study conduct ............................................................................................................. 15 
5.1. Workflow of study groups .............................................................................................................. 15 
5.2 Measurements ................................................................................................................................ 16 
5.2.1 Tools used by observers ............................................................................................................... 16 
5.2.2 Participant questionnaires ........................................................................................................... 18 
5.3 Withdrawal of consent .................................................................................................................... 21 
6. Methods ..................................................................................................................... 22 
6.1 Study parameters ............................................................................................................................ 22 
6.2 Randomization and blinding ............................................................................................................ 23 
6.3 Investigation procedure .................................................................................................................. 23 
6.4 Loss to follow up .............................................................................................................................. 24 
7. Ethics consideration .................................................................................................... 25 
8. Statistical Analysis....................................................................................................... 26 
9. Consent & data protection .......................................................................................... 28 
10. Administration .......................................................................................................... 29 
10.1 Administration and storage of research data ............................................................................... 29 
10.2 Reporting amendments to the Ethics Committee ........................................................................ 29 
10.3 Reporting the progress of the investigation to the Research Ethics Committee .......................... 29 
11. References ................................................................................................................ 30 
12. Attachments ............................................................................................................. 33 
Appendix 1: Content on which TraceBooks’ dynamic digital checklist is based for the  ICU ward 
round (for intensivists and residents) with an image as example. ....................................................... 33 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
5 
 
1A. The currently used paper checklist (local standard of care). ....................................................... 33 
1B. The currently applied clinical rules (local standard of care) ........................................................ 34 
1C. Image as example of TraceBooks’ dynamic digital checklist for the  ICU ward round. ............... 35 
Appendix 2: Content on which TraceBooks’ dynamic digital checklist for the nurses’ shift and 
handover checklists are based with images as example. ...................................................................... 36 
2A. Content current paper nursing handover checklist. .................................................................... 36 
2B. Content current digital nursing shift checklist (current administration in EHR). ......................... 36 
2C. Image as example of TraceBooks’ dynamic digital checklist for nursing handover. ................... 37 
2D. Image as example of TraceBooks’ dynamic digital checklist for nursing shift. ........................... 37 
Appendix 3: Attrakdiff esurvey ........................................................................................................... 38 
Appendix 4: TAM-2 based questionaire .............................................................................................. 39 
 
  
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
6 
 
Summary  
Background 
The effectiveness of 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. Our purpose 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.  
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
7 
 
1. Background and Rationale 
In America, it has been estimated that the deaths of approximately 210.000 hospitalized patients are 
associated with preventable adverse events each year.1 Medical record research in the Netherlands 
reported that each year approximately 10% of the deceased hospitalized patients had a preventable 
adverse event, of which 42% could have been easily prevented.2 These large numbers can be 
explained if one considers that most medical procedures are still based on human memory and 
physicians also have to work with more sophisticated technologies.2–4 To prevent these adverse 
events, a huge diversity of medical guidelines and protocols have been introduced, but it remains a 
challenge to implement them in daily practice. For example, only 56% of the patients in the Intensive 
Care Unit (ICU) are treated according to the best practice for which they are eligible.5 To overcome 
these problems, a benchmark used in other high-risk industries, the checklist, has been tested as a 
method in medical care, with encouraging results.6–11 Haynes et al. showed that the surgical safety 
checklist standardizes preoperative care, resulting in a cost-effective reduction of morbidity and 
mortality.6 Likewise, De Vries et al. demonstrated that implementing multidisciplinary checklists in 
the surgical pathway, from admission to discharge, significantly reduced the proportion of patients 
with one or more complications from 15.4% to 10.6% in Dutch hospitals.8  
However, numerous subsequent studies could not reproduce these beneficial effects, which could be 
due to the remaining challenge of checklist implementation in medical care, i.e. a lack of acceptance 
and compliance.6 8 12–15 A possible cause could be that current static checklists negatively interfere 
with the daily workflow of caregivers because they do not provide contextual information that makes 
it easier to complete the checklist and they cannot include or exclude items based on the 
characteristics of a particular patient and caregiver.   
 
In 2012 Nan et al. created TraceBook, a novel decision support system that integrates workflow 
management with the use of dynamic clinical checklists in a process-oriented and context-aware 
manner to make clinical processes more traceable and the people in it more accountable.16  These 
new forms of intelligent checklists derive their dynamic property from being connected with the 
electronic health record (EHR) and other electronic medical databases. These checklists are therefore 
able to provide real-time relevant information and specific items of patients to the specific user. 
These hypotheses were tested by De Bie et al in a simulation study in 2014. They showed that the 
number of checked items per ICU ward round significantly improved and the number of pharmacists 
calls due to medication alerts would significantly decrease while the acceptance score of the ICU 
doctors for the dynamic digital checklist of the ICU ward round was high.17 However, these outcomes 
were a proof of the concept in a controlled simulated environment and the question remains if these 
results are reproducible in a real life clinical setting. Our hypothesis is that TraceBooks’ dynamic 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
8 
 
characteristics can also ensure in real life practice a high satisfaction rate among clinicians while 
improving the compliance with agreed local care processes. 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
9 
 
2. Aim & study endpoints 
2.1 Goal/hypothesis 
TraceBook, with the use of digital dynamic checklists, improves compliance to care processes on the 
intensive care with a high user acceptance score.  
2.2 Primary endpoint 
The efficacy of TraceBook based on the percentage of daily checked checkable items overall and 
items requiring an intervention per patient. 
2.3 Secondary endpoints 
2.3.1. 
Clinical outcomes of patients admitted to ICU will improve after implementation of 
TraceBooks’ checklists for ICU staff: 
 
• Decreased mortality: ICU, in-hospital, 30 and 90 days.  
• Decreased length of stay (LOS): ICU, hospital. 
• Decreased number of ventilator days. 
 
2.3.2. 
 
Pharmacist specific outcomes will improve after implementation of TraceBooks’ checklists 
for ICU staff: 
 
• Decreased umber of daily ICU medication alerts for the pharmacist based on their 
ICU clinical rules. 
• Decreased number of patients per day needing a telephone call by the pharmacists 
with the responsible clinician of the ICU based on medication alerts by GASTON.  
 
 
2.3.3. 
 
Compliance to specific agreed local care processes will improve after implementation of 
TraceBooks’ checklists for ICU staff: 
 
• Decreased number of gastro-intestinal bleedings (hematemesis or melena), 
ventilator and hospital associated pneumonia and central-venous-catheter-related 
bloodstream infections (CRBSIs).   
• Decreased number of days without prophylactic or therapeutic anticoagulation, 
proton pump inhibitors or SDD, if required based on the guidelines. 
• Increased percentage of performed spontaneous breathing trials and sedation wake 
up calls. 
• Decreased number of days with intravenous sedatives prescribed (Propofol, 
midazolam) 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
10 
 
• Decreased number of days with opiates being prescribed. 
• Decreased number of days with antibiotics being prescribed, while not required for 
treatment. 
• Decreased number of complications registered. 
• Decreased number of registered allergies within 24 hours of ICU admission. 
• Increased number of days where the required amount of calories is prescribed when 
patient receives enteral feeding. 
• Increased number of automatically or administratively checked items. 
 
2.3.4. 
 
User experience outcomes: 
 
• The Attrakdiff questionnaire (appendix 3) at the end of the before period and at the 
end of the after period to assess the pragmatic and hedonic quality of the 
electronic health record with paper checklists and TraceBook. Pragmatic factors 
are, for example, usefulness and usability. Hedonic factors include emotional 
needs, such as curiosity and identification (http://attrakdiff.de/index-
en.html#hello; https://www.uid.com/en/publications/attrakdiff) 
o H1: Pragmatic factor will be better for TraceBooks’ checklists compared to 
the electronic health record with paper checklists. 
o H2: Hedonic factor will be better for TraceBook checklists compared to the 
electronic health record with paper checklists. 
• One questionnaire based on the  Technology Acceptance Model 2 (TAM2) at the end 
of the intervention phase (figure 6 and appendix 4).18–20  
 
o H1: Perceived Usefulness is positively associated with clinicians’ attitudes 
toward using TraceBook. 
o H2: Perceived Ease of Use is positively associated with clinicians’ attitudes 
toward using TraceBook. 
o H3: the perception of perceived Ease of Use of TraceBook will have a 
positive effect on Perceived Usefulness. 
o H4: the perception of the subjective norm of TraceBook will have a positive 
effect on Perceived Usefulness. 
o H5: the perception of the subjective norm of TraceBook will have a positive 
effect on clinicians’ attitudes toward using TraceBook. 
o H6: the perception of the Image of TraceBook will have a positive effect on 
Perceived Usefulness. 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
11 
 
o H7: the perception of Job Relevance of TraceBook will have a positive 
effect on Perceived Usefulness. 
o H8: the perception of Output Quality of TraceBook will have a positive 
effect on Perceived Usefulness. 
o H9: the perception of Results Demonstrability of TraceBook will have a 
positive effect on Perceived Usefulness. 
o H10: the perception of Facilitation of TraceBook will have a positive effect 
on clinicians’ attitudes toward using TraceBook. 
 
 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
12 
 
3. Study design 
 
3.1 Design  
Prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.  
 
The estimated before period of two months for the control group will be: 04-06-2018 till 06-08-2018. 
The estimated after period of two months for the intervention group, TraceBooks’checklists are 
available for ICU staff, will be: 20-08-2018 till 22-10-2018. 
3.2 Setting 
This study will be conducted in the Intensive Care Department of Catharina Hospital Eindhoven, a 
tertiary hospital in The Netherlands. 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
13 
 
4. Research participants  
 
4.1 Participants 
The participants will be the intensive care staff of the Intensive Care Department of Catharina 
Hospital Eindhoven. During the before period they will work as usual, while after introducing 
TraceBook they will be able to use this clinical decision support system that provides them digital 
patient specific checklists of patients who are admitted on the Intensive Care of the Catharina 
Hospital.   
4.2 Recruitment of participants 
ICU management will be informed about the study design. If management approves the design of 
this study then the floor manager and executive manager will sign this protocol document. The ICU 
staff will be informed about the study design and the fact that their participation in ward rounds and 
handovers may be observed. Information will be provided during a presentation before 01-06-2018 
and a message in the newsletter about the concept of this study will be published before the start of 
the study. Participants can indicate that they do not want to be observed. If participants object 
observation than the ward rounds and shift handovers in which they participate will not be observed. 
Observations will only be done for this research objective. 
4.3 Sample size calculation 
Since there is no previous clinical study it is difficult to perform a sample size calculation based on 
clinical evidence. For this sample size calculation we will therefore use the outcomes from the pilot-
simulation-study of De Bie et al.21 
In the simulation study a significant difference was found in the percentage of checked items and 
critical items during ward round with 116 observed scenarios (60 observation in the control group 
and 56 in the intervention group).  A power sample size calculation with G*Power (version 3.1.9.2.; 
Franz Faul, Universitiet Kiel,Duitsland) based on the median percentage of checked items during the 
simulation study (73.6% (IQR: 64.5–79.3) for the control group and 100% (IQR: 100.0–100.0) for the 
intervention group with a p<0.001 and z-score =7.74) shows that 44 observations are needed during 
both periods to achieve a power of 95% with an α of 0.05. In this study some flaws were 
incorporated in the simulation scenarios that generated some specific relevant items. However, this 
incorporation of flaws cannot be controlled in a clinical proof of concept study. Therefore we 
estimate that the number of observation must be more, aiming on 120  observations for both the 
before and the after group. 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
14 
 
Based on the annual admission rate of patients on the IC in 2016 being reassessed for a period of 2 
months we estimate to be able to perform at least 4 observations per working day, which is at least 
160 observations in 2 months. However, since this is a before-after observational study we will try to 
perform as many observations as logistically possible. 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
15 
 
5. Study conduct  
5.1. Workflow of study groups  
This is a controlled before-after study starting with two months of observation of local standard of 
care followed by the implementation of TraceBook on the ICU with two months of observation.  
During the before period members of the research team will perform observations of ward rounds 
and nurses’ shift handovers. To overcome the Hawthorne effect as much as possible observations 
will be performed behind a computer, out of the sight of the observed clinicians, which shows 
footage of the room in which the ward round or shift handover is without any actual recording of 
footage. A headphone will be used to listen to the conversations without any recording. 
The observation will be scored based on the number of items that are relevant for the patient. This 
number of items will be generated by TraceBook and printed on paper. During the before period the 
generated checklist items of TraceBook will only be available for the observers of the research team 
(figure 1). The observer then checks if an item is discussed or registered. The current used paper 
checklist will be available as usual.  
After the introduction of TraceBook ICU clinicians will be able to use TraceBook and check items for 
the ward round and nurses’s shifts and handovers for a period of two months. During this after 
period observations will be done and an item will be considered as checked if it is checked within 
TraceBook or is discussed in the room (figure 2). The current used paper checklist will still be 
available for clinician to use if desired. 
A second opinion of the generated items by TraceBook will be performed by the observers of the 
research team for each patient during both periods. In the event that they decide a generated item 
by TraceBook was not applicable to the patient, an independent physician of the intensive care (not 
part of the research team) will arbitrate and a consensus will be reached on whether to include the 
item or not for analysis.  
 
In addition, during both periods, each day pharmacists will count the number of alerts that were 
provided by GASTON based on predetermined pharmacological clinical rules for the ICU. They will 
also assess the number of patients for whom they have to inform the responsible clinician about the 
alert.  

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
16 
 
Figure 1. Standard operating procedure during before 
(control) period; TraceBook is only available for the 
research team (observers). 
Figure 2. Standard operating procedure during after 
(intervention) period; TraceBook is available for ICU 
clinicians and the research team. 
 
 
5.2 Data measurements  
5.2.1 Tools used by observers 
The following tools will be used to collect the described data in “6.1 study parameters”: 
Electronic health record (EHR): 
Investigators of the research team will use the EHR to collect: 
 
Patient characteristics of patients admitted to ICU during the study. 
 
Clinical outcomes of patients admitted to ICU during the study. 
 
Registered complications and prescribed medication. 
 
Registered allergies in the EHR, within 24 hours after ICU admission.   
 
The calculated and prescribed amount of calories of enteral or parenteral feeding. 
TraceBook: 
TraceBook is a novel decision support system that integrates workflow management with the use of 
dynamic clinical checklists in a process-oriented and context-aware manner to make clinical 
processes more traceable and the people in it more accountable.16 21 These new forms of intelligent 
checklists derive their dynamic property from being connected with the EHR and other electronic 
medical databases. These checklists are therefore able to provide real-time relevant information and 
specific items of patients to the specific user.21 There will be two checklists available for the clinician:  
1. TraceBook’s ICU ward round checklist for physicians (appendix 1):  
The content is based on the currently available paper checklist (appendix 1A; with FASTHUGS 
mnemonic) and locally applied ICU related clinical rules (appendix 1B). 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
17 
 
2. TraceBooks’ nurses’ handover and shift checklists (appendix 2): 
The content is based on the paper handover checklist (appendix 2A) and currently required 
administration within the EHR (appendix 2B).  
 
With TraceBook the following parameters will be generated and collected: 
 
The number of checkable items per patient. 
 
The number of checked items: 
o Before period: completed by the observers based on their observation. The observer 
observes if the item is checked by registering on paper, in the EHR, or if it is only 
discussed in the room. 
o After period: completed by the ICU staff and observers based on their observation . 
The observer observes if the item is checked by registering on paper, in the EHR, or if 
it is only discussed in the room.. 
 
Attrakdiff esurvey: 
To assess the pragmatic and hedonic quality of the EHR with paper checklists and TraceBook for 
daily use during ICU ward rounds and ICU nurses’ shifts and handovers.  
 
TAM-2 based questionnaire: 
To assess the user acceptance of the EHR with paper checklists and TraceBook for daily use during 
ICU ward rounds and ICU nurse handovers. The questions of this questionnaire are based on the 
international accepted and validated Technology Acceptance Model 2 (TAM2). Questions will be 
presented to the participants with a survey on paper and a survey made with SurveyMonkey. 
Participants can only participate once. 
5.2.2 Participant questionnaires 
All ICU staff, physicians and nurses, will be asked to complete the attrakdiff esurvey and the TAM-2 
survey during the study. 
 
The Attrakdiff esurvey: 
To assess the pragmatic and hedonic quality of the EHR with paper checklists and TraceBook for 
daily use during ICU ward rounds and ICU nurses’ shifts and handovers. The model of the attrakdiff 
esurvey separates four essential aspects: 
1. The product quality intended by the designer. 
2. The subjective perception of quality and subjective evaluation of quality. 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
18 
 
3. The independent pragmatic and hedonic qualities. 
4. Behavioral and emotional consequences. 
How the pragmatic and hedonic qualities influence the subjective perception of attractiveness giving 
rise to consequent behavior and emotions is illustrated in figure 3. The survey consists of 28 seven-
step items whose poles are opposite adjectives. (site; http://attrakdiff.de/sience-en.html). 
The attrakdiff esurvey will be send to all ICU staff during both periods: 
• 
Before period: ICU physicians and nurses will complete this esurvey at the end of the after 
period (figure 5). The participation is voluntary and ICU staff receives the esurvey by email with a 
reminder after one week. 
• 
After period: ICU physicians and nurses will complete this esurvey at the end of the second 
month of the after period (figure 5). The participation is voluntary and ICU staff receives the esurvey 
by email with a reminder after one week. 
Figure 3: Model of the attrakdiff esurvey.  
TAM-2 based questionnaire: 
The TAM-2 model is used to assess the user acceptance the EHR with paper checklists and 
TraceBook. This model contains two key constructs, perceived usefulness and ease of use, with 
several variables, subjective norm, image, job relevance, output quality and results demonstrability,  
that influence the user acceptance of TraceBook (figure 4).19 The definitions of the variables are 
described in table 1.The TAM-2 based questionnaire that assesses the user acceptance of TraceBook 
contains 58 questions on a 5-point Likert scale (with 1 totally disagree, 2 disagree, 3 neutral, 4 agree, 
and 5 totally agree) that cover all these key constructs and variables (table 2). The participation to 
complete the questionnaire is always voluntary. The TAM-2 based questionnaire will be send to all 
ICU staff by e-mail (SurveyMonkey), with a reminder after one week. It will also be available on paper 
on the ICU. Participants can only participate once. 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
19 
 
Figure 4. TAM-2 model: 
 
Table 1. Definitions of the key constructs and variables of TAM-2.19 
Key constructs and 
variables 
Definitions applicable to TraceBook 
Perceived usefulness 
A person's perception that using TraceBook will enhance job performance 
(HK) 
Perceived Ease of Use 
A person's perception that using TraceBook will be free of effort (HK) 
Subjective norm 
A person's perception that most people who are important to him think 
he should or should not use TraceBook (4) 
Image 
A person's perceived image of TraceBook that influence the perceived 
usefulness (HK) 
Job Relevance 
A person's perception regarding the degree to which TraceBook is applicable 
to his/her job (WU) 
Output Quality 
the degree to which an individual judges the effect of TraceBook. 20 
Results Demonstrability 
Tangibility of the results of  using TraceBook 14 
Table 2. Distribution of the questions in the TAM-2 questionnaire in the variables of the TAM-2 model: 
Variable 
Subvariable 2 
Question 
Age, experience, sex and job 
Q1-3 
Perceived usefulness 
Subjective norm 
T4-7; US10 
Image 
U10, 14; US 1-9; G 3,7 
Job Relevance 
U1, 13, 14; G2 
Output Quality 
U2,3,4,8, 11; G1, 5 
Results Demonstrability 
U5-7, 9, 12 
Perceived Ease of Use 
Ease of Use 
EU 1-11; G4 
Facilitation 
T1-3, 8; EU 12-13 
Other, not TAM-2 related questions. 
G8 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
20 
 
5.3 Withdrawal of consent  
In this study participation of the ICU staff is completely voluntary. Participants can always abort 
participation or disagree to further observation at any moment during the study. The use of 
TraceBook is also not mandatory. They do not have to provide any reason for both issues. If a 
participant want to withdrawal all collected data till the moment of withdrawal will be available for 
analyses. 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
21 
 
6. Methods  
6.1 Study parameters 
 
Primary endpoint: 
Efficacy: 
The efficacy will be determined by comparing the percentage of items, generated by TraceBook, that 
were vocally and/or administratively checked during the before period with the percentage of vocally 
or administratively checked items in TraceBook during the after period. The percentage per patient is 
used since the number of items can vary as TraceBook generates patient specific checkable items. 
 
Secondary endpoints: 
Patient characteristics of the patients who were admitted during the before and after period: 
 
Medical history: diabetes mellitus, recent surgery, number of chronic diseases, charlson 
comorbidity index. 
 
Severity of the disease at admission: APACHE IV, Standardized Mortality Ratio and qSOFA 
 
Age, sex 
 
Reason for ICU admission 
 
Laboratory measurement at admission: Hemoglobin, leukocytes, bilirubin, creatinine,  urea, 
CRP, lactate, P/F ratio 
 
Clinical outcomes of the patients who were admitted during the before and after period: 
 
Mortality; ICU, in-hospital, both 30 as 90 day.  
 
Length of stay (LOS) in ICU, LOS in hospital 
 
The number of ventilator days. 
 
Pharmacist specific outcomes during both periods: 
 
Number of daily ICU medication alerts for the pharmacist based on their ICU clinical rules. 
 
Number of patients per day needing a telephone call by the pharmacists with the responsible 
clinician of the ICU based on medication alerts by GASTON.  
 
Checkable item specific outcomes during both periods: 
 
Number of gastro-intestinal bleedings (hematemesis or melena), ventilator and hospital 
associated pneumonia and central-venous-catheter-related bloodstream infections (CRBSIs).   

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
22 
 
 
Number of days without prophylactic or therapeutic anticoagulation, proton pump inhibitors 
or SDD, if required based on the guidelines. 
 
Number of days with intravenous sedatives prescribed (propofol, midazolam) 
 
Number of days with opiates being prescribed. 
 
Number of days with antibiotics being prescribed. 
 
Number of complications registered ICU clinicians in the EHR and by the observers (research 
team). 
 
Number of registered allergies within 24 hours of ICU admission. 
 
Number of days with the correct amount of required calories prescribed for enteral or 
parenteral nutrition. 
 
Number of automatically, or discussed and registered observed checked items per patient 
per day. 
 
User experience outcomes: 
 
Attrakdiff esurvey (appendix 3) to assess the pragmatic and hedonic quality. 22 23   
 
TAM-2 based questionnaire (appendix 4). 18–20 
 
6.2 Randomization and blinding 
 
Participants will not be randomized since this is a controlled before-after observation study. Both 
participants and researcher can also not be blinded during both periods since the researchers need 
to use the TraceBooks’ checklists during both periods and participants only during the after period.  
 
6.3 Investigation procedure 
 
The timeline of the study procedures is demonstrated in figure 5. 
Before (control) period (2 months):  
- ICU staff will perform their daily work by local standard of care, which also contains applying 
available paper checklists and EHR that can be used if desired (appendix 1 and 2).  
- The daily ICU ward rounds and nurses’ handovers are observed during working days by investigators 
of the research team out of sight of the ICU staff. 
- In the second month ICU staff receives the Attrakdiff esurvey to assess the pragmatic and hedonic 
quality of the EHR (Chipsoft) with paper checklists. A reminder is send after one week if not being 
completed by then. 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
23 
 
- After two months ICU staff receives the TAM-2 based questionnaire to assess the user acceptance 
of the EHR (Chipsoft) with paper checklists. A reminder is send after one week if not being completed 
by then. 
After (intervention) period (2 months): 
- ICU staff will perform their daily work by local standard of care, in which now also the checklists of 
TraceBook (content is based on currently applied paper checklist and clinical rules; appendix 1 and 2) 
are available besides the paper checklists and EHR. Both can be used if desired.  
-  In the second month ICU staff receives the Attrakdiff esurvey to assess pragmatic and hedonic 
quality of TraceBook. A reminder is send after one week if not being completed by then. 
- After two months ICU staff receives the TAM-2 based questionnaire to assess the user acceptance 
of TraceBook. A reminder is send after one week if not being completed by then. 
 
Figure 5: The timeline of the study. 
 
6.4 Loss to follow up 
 
ICU staff will be considered loss to follow up if they abort participation or disagree to further 
observations. The data till the withdrawal will be still available for analyses.  
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
24 
 
7. Ethics consideration 
 
In the Netherlands this study falls outside the scope of the Medical Research Involving Human 
Subjects Act (WMO) since the participants, ICU staff, are not subjected to procedures or are required 
to follow rules of behavior. The CDSS TraceBook does not subject users to follow procedures or 
specific rules as it only advises the users on some topics. The users, ICU staff, always decide the 
procedure and can therefore decide to agree, or not, with the advice of a TraceBooks’ checklist and 
can always decide to not use TraceBook as this is not mandatory. The advices of 
TraceBooks’checklists are also based on the local guidelines. 
For this study we will only use (medical) data of admitted patients on the ICU that already needs to 
be registered as part of their treatment. 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
25 
 
Table 3: Internal consistencies 
base on Cronbach’s alpha 
8. Statistical Analysis  
 
Statistical analyses shall be performed with SPSS version 23.0/24.0 (IBM Corp. Armonk, NY, USA), 
AMOS 23 (IBM Corp. Armonk, NY, USA) or with Excel 2013 (Microsoft Office). The distribution of 
continuous variables will be assessed with Kolmogorov-Smirnov tests. The patient and participant 
characteristics will be described as descriptive statistics. 
 
Normally distributed data will be analyzed with the following parametric tests: The chi-square test, 
independent-samples t-test, the Mann-Whitney U test shall be used to analyze the data if the data is 
not normally distribute, and a two-sided p-value less than 0.05 will be considered statistical 
significant. 
 
The results of the TAM-2 based questionnaire will be analyzed with SPSS version 23.0/24.0 (IBM 
Corp. Armonk, NY, USA) and AMOS 23 (IBM Corp. Armonk, NY, USA). The correlation between 
variables will be measured by Pearson’s correlation and regression tests. Internal consistencies 
among scale items will be calculated using Cronbach’s alpha. Internal consistencies are given in table 
3. 
The Structural Equation Modeling (SEM) will be used to analyze the predicted paths. SEM is the 
preferred approach for analyzing interactions between multiple independent and depended 
variables, such as those used in this study. The proposed conceptual path model is described in figure 
6. A p-value of less than 0.05 will be considered as statistical significant.  

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
26 
 
 
 
Figure 6: TAM-2 with hypotheses.  

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
27 
 
9. Consent & data protection 
 
ICU management will be informed about the study design. If management approves the design of 
this study then the floor manager and executive manager will sign this protocol document. The ICU 
staff will be informed about the study design and the fact that their participation in ward rounds and 
handovers may be observed during the study at least one week before the study starts. Information 
will be provided during a presentation and a message in the newsletter about the concept of this 
study will be published before the start of the study. Participants can indicate that they do not want 
to be observed. If participants object observation than the ward rounds and shift handovers in which 
they participate will not be observed. Observations will only be done for this research objective. 
 
All digital data will be stored in databases on a password-protected computer and can only be 
accessed by the local or principal investigators. Confidentiality of participants and patients will be 
protected by anonymizing all results. No identifiable details will be recorded as part of the study 
documentation.  
 
The study will comply with the principles of the World Medical Association Declaration of Helsinki 
good clinical practice. 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
28 
 
10. Administration  
 
10.1 Administration and storage of research data 
Research data will consist of digital completed checklists by observers (before period) and 
participants (after period) combined with patient characteristics and outcomes from the EHR. All 
research data will be analyzed and noted in digital databases of SPSS and Excel. The data will be 
noted in these databases in such a way that the data cannot be traced back to the participants or the 
patients that were admitted on the ICU. These databases will be saved on the internal server of the 
principal investigator within the Catharina Hospital Eindhoven. All data on paper will be scanned and 
digitalized, so that all digital data will be stored for at least ten years after the investigation on an 
internal sever in the hospital.  
An account on the website http://attrakdiff.de will be used to generate and receive the results of the 
Attrakdiff esurvey. These results will be stored on the internal server of the principal investigator 
within the Catharina Hospital Eindhoven. The research hospital account of SurveyMonkey will be 
used send the TAM-2 based questionnaire to the participants and generate the outcomes. These 
outcomes will be stored on the internal server of the principal investigator within the Catharina 
Hospital Eindhoven. 
 
10.2 Reporting amendments to the Ethics Committee 
Amendments will be communicated to the relevant Ethics Committee, which will communicate with 
the principal investigator. 
 
10.3 Reporting the progress of the investigation to the Research Ethics Committee 
The principal investigator will inform the responsible local Research Ethics Committee, if required, 
after completing the study within eight weeks. If the investigation is terminated prematurely, the 
principal investigator shall inform the local REC about the termination. 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
29 
 
11. References  
1.  
James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. J 
Patient Saf [Internet] 2013; 9: 122–8 Available from: 
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=01209203-
201309000-00002 
2.  
Langelaan M, Broekens MA. Monitor Zorggerelateerde Schade 2015 / 2016 Dossieronderzoek 
bij overleden patiënten in Nederlandse ziekenhuizen. 2016.  
3.  
Thomassen Ø, Espeland A, Søfteland E, Lossius H, Heltne J, Brattebø G. Implementation of 
checklists in health care; learning from high-reliability organisations. Scand J Trauma Resusc 
Emerg Med [Internet] BioMed Central Ltd; 2011; 19: 53 Available from: 
http://sjtrem.biomedcentral.com/articles/10.1186/1757-7241-19-53 
4.  
Vincent J-L. Give your patient a fast hug (at least) once a day*. Crit Care Med [Internet] 2005; 
33: 1225–9 Available from: 
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00003246-
200506000-00005 
5.  
Ilan R, Fowler RA, Geerts R, Pinto R, Sibbald WJ, Martin CM. Knowledge translation in critical 
care: Factors associated with prescription of commonly recommended best practices for 
critically ill patients*. Crit Care Med [Internet] 2007; 35: 1696–702 Available from: 
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00003246-
200707000-00012 
6.  
Haynes, A.B., Weiser, T.G., Berry, W.R.  et al. A Surgical Safety Checklist to Reduce Morbidity 
and Mortality in a Global Population. N Engl J Med 2009; 360: 491–9  
7.  
Blot K, Bergs J, Vogelaers D, Blot S, Vandijck D. Prevention of central line-associated 
bloodstream infections through quality improvement interventions: A systematic review and 
meta-analysis. Clin Infect Dis 2014; 59: 96–105  
8.  
de Vries EN, Prins HA, Crolla RMPH, et al. Effect of a comprehensive surgical safety system on 
patient outcomes. J Urol [Internet] 2011; 185: 1329–30 Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/22115486 
9.  
Conroy KM, Elliott D, Burrell AR. Testing the implementation of an electronic process-of-care 
checklist for use during morning medical rounds in a tertiary intensive care unit: a prospective 
before–after study. Ann Intensive Care [Internet] Springer Paris; 2015; 5: 20 Available from: 
http://www.annalsofintensivecare.com/content/5/1/20 
10.  
Brunsveld-Reinders AH, Arbous MS, Kuiper SG, de Jonge E. A comprehensive method to 
develop a checklist to increase safety of intra-hospital transport of critically ill patients. Crit 
Care [Internet] ???; 2015; 19: 214 Available from: http://ccforum.com/content/19/1/214 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
30 
 
11.  
A Nama, S Sviri, A Abutbul, I Stav P van H. Successful introduction of a daily checklist to 
enhance compliance with accepted standards of care in the medical intensive care unit. 
Anaesth Intensive Care 2016; 44: 498–500  
12.  
Borchard A, Schwappach DLB, Barbir A, Bezzola P. A Systematic Review of the Effectiveness, 
Compliance, and Critical Factors for Implementation of Safety Checklists in Surgery. Ann Surg 
[Internet] 2012; 256: 925–33 Available from: 
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00000658-
201212000-00011 
13.  
van Klei WA, Hoff RG, van Aarnhem EEHL, et al. Effects of the Introduction of the WHO 
‘Surgical Safety Checklist’ on In-Hospital Mortality. Ann Surg [Internet] 2012; 255: 44–9 
Available from: 
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00000658-
201201000-00008 
14.  
de Vries EN, Prins HA, Bennink MC, et al. Nature and timing of incidents intercepted by the 
SURPASS checklist in surgical patients. BMJ Qual Saf [Internet] 2012; 21: 503–8 Available 
from: http://qualitysafety.bmj.com/lookup/doi/10.1136/bmjqs-2011-000347 
15.  
Fourcade A, Blache J-L, Grenier C, Bourgain J-L, Minvielle E. Barriers to staff adoption of a 
surgical safety checklist. BMJ Qual Saf [Internet] 2012; 21: 191–7 Available from: 
http://qualitysafety.bmj.com/lookup/doi/10.1136/bmjqs-2011-000094 
16.  
Nan S, Van Gorp P, Korsten HHM, et al. Tracebook: A dynamic checklist support system. Proc - 
IEEE Symp Comput Med Syst 2014; 48–51  
17.  
De Bie AJR, Nan S, Vermeulen LRE, et al. Intelligent dynamic clinical checklists improved 
checklist compliance in the intensive care unit. Br J Anaesth 2017; 119  
18.  
Davis FD. Perceived Usefulness , Perceived Ease Of Use , And User Acceptance. MIS Q 1989; 
13: 319–39  
19.  
In F, Care H, Holden RJ, Karsh B-T. the Technology Acceptance Model : Its Past and Its Future 
in Health Care. J Biomed Inf [Internet] 2011; 43: 1–30 Available from: 
http://linkinghub.elsevier.com/retrieve/pii/S1532046409000963%0Ahttp://www.ncbi.nlm.nih
.gov/pmc/articles/PMC2814963/ 
20.  
Viswanath Venkatesh FDD. A Theoretical Extension of the Technology Acceptance Model: 
Four Longitudinal Field Studies. Manage Sci 2000; 46: 186–204  
21.  
De Bie AJR, Nan S, Vermeulen LRE, et al. Intelligent dynamic clinical checklists improved 
checklist compliance in the intensive care unit. Br J Anaesth 2017; 119: 231–8  
22.  
Hassenzahl M, Burmester M, Koller F. Attrakdiff esurvey [Internet]. 2017. Available from: 
http://attrakdiff.de/sience-en.html 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
31 
 
23.  
Hassenzahl M, Kekez R, Burmester M. The importance of a software’s pragmatic quality 
depends on usage modes. Proc 6th Int Conf Work With Disp Units (WWDU 2002) 2002; 3: 
275–6  
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
32 
 
12. Attachments 
Appendix 1: Content on which TraceBooks’ dynamic digital checklist is based for the  
ICU ward round (for intensivists and residents) with an image as example. 
1A. The currently used paper checklist (local standard of care). 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
33 
 
1B. The currently applied clinical rules (local standard of care). 
Clinical rule: 
1. 
The system checks if Methotrexate, with folic acid is administered;  
If so, it will provide a checkable item to check if dosage is correct and if folic acid is administered.  
2. 
The system checks if nephrotoxic medication is administered in case of kidney dysfunction; 
If so, it will provide a checkable item to check if nephrotoxic medication is needed or if the dosage 
can be changed. 
3. 
The system checks if laxatives are started simultaneously with the administered opiates; 
If not, it will provide a checkable item to start laxatives when there are no contraindications 
4. 
The system checks if aminoglycosides are administered; 
If so, it will provide a checkable item to check if aminoglycosides levels are monitored and if dosage is 
correct. 
5. 
The system checks if there is a hyper- or hypokalium and if so it checks if there is any medication 
responsible for it. 
If so, it will provide a checkable item to check potassium levels and medication. 
6. 
The system checks if there is a hyper- or hyponatrium and if so it checks if there is any medication 
responsible for it. 
If so, it will provide a checkable item to check natrium levels and medication. 
7. 
The system checks if there is a hyper- or hypocalcemia and if so it checks if there is any medication 
responsible for it. 
If so, it will provide a checkable item to check calcium levels and medication. 
8. 
The system checks if stress ulcer prophylaxis is started and checks if NSAIDs are started. 
If not so, it will provide a checkable item to start stress ulcer prophylaxis and to check if NSAID is 
necessary. 
9. 
The system checks if the patient with heart failure gets medication that is contraindicated in heart 
failure. 
If so, it will provide a checkable item to check if this medication is necessary and to evaluate if it can 
be stopped. 
10. 
The system checks if the INR is >6. 
If so, it will it will provide a checkable item to suggest to start Vitamin K. 
11. 
The system checks if Lithium is prescribed for the patient and if blood levels of Lithium are known 
and acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of lithium or if the dosage 
of Lithium needs to be modified. 
12. 
The system checks if Digoxin is prescribed for the patient and if blood levels of Digoxin are known and 
acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of Digoxin or if the dosage 
of Digoxin needs to be modified. 
13. 
The system checks if Clozapine is prescribed for the patient and if blood levels of Clozapine are 
known and acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of Clozapine or if the 
dosage of Clozapine needs to be modified. 
14. 
The system checks if Phenytoin is prescribed for the patient and if blood levels of Phenytoin are 
known and acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of Phenytoin or if the 
dosage of Phenytoin needs to be modified. 
15. 
The system checks if enteral feeding and levothyroxine are given at the same time. 
If so, it will provide a checkable item to suggest skip one bolus of enteral feeding or pause enteral 
feeding for half an hour if given continuously. 
16. 
The system checks if dalteparin dosage >5000IE/day if the patient is >80kg. 
If not so, it will provide a checkable item to start daltaparin 5000IE/day. 
17. 
The system checks if the patient gets Daltaparin and whether the INR is two consecutive times > 2.2 
If so, it will provide a checkable item to suggest pausing the Dalteparin. 
18. 
The system checks if the patient gets Amiodaron 1200mg/24hr >3 days  
If so, it will provide a checkable item to suggest to correct the dosage to 600mg/24hr or start oral 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
34 
 
Amiodaron. 
19. 
The system checks if Vancomycin is prescribed for the patient and if blood levels of Vancomycin are 
known and acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of Vancomycin or if the 
dosage of Vancomycin needs to be modified. 
20. 
The system checks if Amikacin is prescribed for the patient and if blood levels of Amikacin are known 
and acceptable. 
If so, it will provide a checkable item to suggest checking the blood levels of Amikacin or if the dosage 
of Amikacin needs to be modified. 
21. 
The system checks if selective oral decontamination is prescribed for patient admitted on the IC >48 
hours. 
If not so, it will provide a checkable item to suggest starting selective oral decontamination. 
22. 
The system checks if the patient has an enteral tube and if the prescribed medication is eligible to be 
given through the enteral tube. 
If not so, it will provide a checkable item to suggest to change the ineligible medication to medication 
that can be given intravenously of with the enteral tube.  
23. 
The system checks if a venous or arterial line is in situ >7 days. 
If so, it will provide a checkable item to consider change the line or evaluate if the line is still needed. 
  
 
1C. Image as example of TraceBooks’ dynamic digital checklist for the  ICU ward 
round. 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
35 
 
Appendix 2: Content on which TraceBooks’ dynamic digital checklist for the nurses’ 
shift and handover checklists are based with images as example. 
 
2A. Content current paper nursing handover checklist. 
Date ../../…. 
15.00 
23.00 
07.30 
Ventilator settings on bed list 
correspond to the ventilator?  
 
 
 
Humidifier is on? 
 
 
 
Respiration (VUE link) is secured? 
 
 
 
Medication Pump rates correspond 
to rates on bed list? 
 
 
 
Shelf lives of all medication syringes 
in pumps are sufficient? 
 
 
 
Are any medication syringes in 
pumps empty <2hours. 
 
 
 
All medication is checked  
 
 
 
All supposed interventions are 
double checked on the bedside list. 
 
 
 
Name nurse 
 
 
 
2B. Content current digital nursing shift checklist (current administration in EHR). 
General 
Open text field 
Hemodynamics 
Open text field 
Pulmonary 
Open text field 
Tube position 
Left / Right / middle 
Tube depth 
…cm 
Renal 
Open text field 
Fluid balance 
… ml 
Diuresis  
…ml/24hrs 
Gastro-intestinal 
Open text field 
Required amount of calories 
Open text field 
Freq. defecation 
…x 
Wounds/drains 
Open text field 
Cerebral 
Open text field 
Delirium 
Yes / No / possible (if yes CAM-ICU) 
RASS 
Score -5 to 4. 
Pain 
Open text field 
VAS 
1-10 
Social 
Open text field 
Skin 
Open text field 
Weight 
…kg 
Weight deviation from admission weight 
…kg 
Extra information 
Open text field 
 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
36 
 
2C. Image as example of TraceBooks’ dynamic digital checklist for nursing 
handover. 
 
2D. Image as example of TraceBooks’ dynamic digital checklist for nursing shift. 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
37 
 
Appendix 3: Attrakdiff esurvey. 
https://esurvey.uid.com/survey/#!wizard/uid-test-attrakdiff-03/0 
 
Age? 
Sex? 
Profession? 
Job experience on ICU? 
human 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
technical 
isolating 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
connective 
pleasant 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
unpleasant 
inventive 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
conventional 
simple 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
complicated 
professional 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
unprofessional 
ugly 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
attractive 
practical 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
impractical 
likeable 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
disagreeable 
cumbersome 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
straightforward 
stylish 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
tacky 
predictable 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
unpredictable 
cheap 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
premium 
alienating 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
integrating 
brings me closer 
to people 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
separates me 
from people 
unpresentable 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
presentable 
rejecting 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
inviting 
unimaginative 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
creative 
good 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
bad 
confusing 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
clearly structured 
repelling 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
appealing 
bold 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
cautious 
innovative 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
conservative 
dull 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
captivating 
undemanding 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
challenging 
motivating 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
discouraging 
novel 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
ordinary 
unruly 
○ 
○ 
○ 
○ 
○ 
○ 
○ 
manageable 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
38 
 
Appendix 4: TAM-2 based questionnaire. 
https://nl.surveymonkey.com/r/TAM2surveyICU 
Q1. Ik werk als: IC verpleegkundige of IC A(N)IOS/PA-er of Intensivist. 
Q2. Mijn ervaring op de IC is: … jaar. 
Q3. Mijn geslacht: man/vrouw 
Q4. Leeftijd: … jaar. 
 
Vraag/score 
1  
Volledig 
oneens 
2  
Oneens 
3 
Neutraal 
4 
Eens 
5 
Volledig 
eens 
 
Training & Support: 
 
 
 
 
 
T1 
De mail over het gebruik van TraceBook was duidelijk.  
1 
2 
3 
4 
5 
T2 
De voordracht over TraceBook was duidelijk 
1 
2 
3 
4 
5 
T3 
Na de uitleg over TraceBook had ik onvoldoende vertrouwen 
om TraceBook te gebruiken 
5 
4 
3 
2 
1 
T4 
Collega’s die ik waardeer vinden dat ik TraceBook moet 
gebruiken. 
1 
2 
3 
4 
5 
T5 
Superieuren vinden dat ik TraceBook moet gebruiken. 
1 
2 
3 
4 
5 
T6 
Vanuit mijn persoonlijke waarden vind ik dat ik TraceBook 
moet gebruiken. 
1 
2 
3 
4 
5 
T7 
Management vindt dat ik TraceBook moet gebruiken. 
1 
2 
3 
4 
5 
T8 
Er was iemand bereikbaar om me te assisteren als ik 
problemen had met TraceBook. 
1 
2 
3 
4 
5 
 
De bruikbaarheid (usefulness) 
 
 
 
 
 
U1 
TraceBook is goed bruikbaar voor mijn werk 
1 
2 
3 
4 
5 
U2 
TraceBook zorgt er voor dat de behandeling meer gebaseerd is 
op wetenschappelijk bewijs. 
1 
2 
3 
4 
5 
U3 
Met TraceBook kon ik mijn taken en de visite/overdracht  niet 
effectief voltooien. 
5 
4 
3 
2 
1 
U4 
Met TraceBook was ik in staat om mijn taken en de 
visite/overdracht snel te voltooien. 
1 
2 
3 
4 
5 
U5 
Ik denk dat TraceBook de kwaliteit van zorg kan verbeteren. 
1 
2 
3 
4 
5 
U6 
TraceBook verbetert de medicatie veiligheid van de patiënt. 
1 
2 
3 
4 
5 
U7 
TraceBook verbetert de kwaliteit van mijn geleverde werk bij 
visites/overdrachten. 
1 
2 
3 
4 
5 
U8 
Met TraceBook was ik in staat om mijn taken en de 
visite/overdracht efficiënt te voltooien. 
1 
2 
3 
4 
5 
U9 
Als informatie niet dubbel genoteerd hoeft te worden, dan 
maakt TraceBook mijn administratie makkelijker. 
1 
2 
3 
4 
5 
U10 
De informatie bolletjes met richtlijnen zijn een aanvulling op 
de te checken items. 
1 
2 
3 
4 
5 
U11 
Ik denk dat het gebruik van TraceBook complicaties niet kan 
voorkomen. 
5 
4 
3 
2 
1 
U12 
TraceBook maakt mijn werk makkelijker uitvoerbaar. 
1 
2 
3 
4 
5 
U13 
TraceBook verbetert de dagelijkse behandeling en 
management van de patiënt. 
1 
2 
3 
4 
5 
U14 
TraceBook is een goede geheugensteun. 
1 
2 
3 
4 
5 
U15 
TraceBook sluit goed aan op mijn dagelijkse werk. 
1 
2 
3 
4 
5 
 
 

TraceBook: clinical proof of concept ICU; Version 1.0, 01-03-2018 
 
39 
 
 
Vraag/score 
1 
Volledig 
oneens 
2  
Oneens 
3 
Neutraal 
4 
Eens 
5 
Volledig 
eens 
 
Gebruiksvriendelijkheid (ease of use) 
 
 
 
 
 
EU1 
Het gebruik van TraceBook is eenvoudig.  
1 
2 
3 
4 
5 
EU2 
De adviezen afgegeven door de checklist waren duidelijk. 
1 
2 
3 
4 
5 
EU3 
De gebruikersinterface van TraceBook is prettig. 
1 
2 
3 
4 
5 
EU4 
Het was eenvoudig om de informatie te vinden die ik nodig 
had in TraceBook. 
1 
2 
3 
4 
5 
EU5 
De lay-out van TraceBook is onoverzichtelijk. 
5 
4 
3 
2 
1 
EU6 
Het zou handiger zijn als de gebruiker de adviezen van 
TraceBook met één klik kan overnemen in het elektronisch 
patiëntdossier. 
1 
2 
3 
4 
5 
EU7 
Het gebruik van TraceBook kon ik snel onder de knie krijgen. 
1 
2 
3 
4 
5 
EU8 
Het gebruik van TraceBook koste mij weinig moeite. 
1 
2 
3 
4 
5 
EU9 
Als ik een fout maakte in TraceBook dan kon ik dit moeilijk 
oplossen. 
5 
4 
3 
2 
1 
EU10 
Het was eenvoudig om relevante patiënt-gerelateerde 
informatie te vinden in TraceBook. 
1 
2 
3 
4 
5 
EU11 
TraceBook heeft het vermogen om de administratie te 
verminderen. 
1 
2 
3 
4 
5 
EU12 
TraceBook zou beter werken op een telefoon of tablet. 
5 
4 
3 
2 
1 
EU13 
TraceBook was makkelijk toegankelijk. 
1 
2 
3 
4 
5 
 
Invloed op gedrag 
 
 
 
 
 
Us1 
Ik wil TraceBook gebruiken omdat het mij helpt 
1 
2 
3 
4 
5 
Us2 
Zonder de TraceBook heb ik het gevoel dat ik belangrijke 
zaken vergeet. 
1 
2 
3 
4 
5 
Us3 
Ik heb het gevoel dat ik door TraceBook de patiënt beter 
behandel. 
1 
2 
3 
4 
5 
Us4 
Het gebruik van TraceBook is een goed idee 
1 
2 
3 
4 
5 
Us5 
Werken met TraceBook is niet leuk 
5 
4 
3 
2 
1 
Us6 
Door TraceBook zie ik mezelf als een betere zorgverlener. 
1 
2 
3 
4 
5 
Us7 
Werken met TraceBook is omslachtig 
5 
4 
3 
2 
1 
Us8 
Ik durf niet meer zonder TraceBook te werken 
1 
2 
3 
4 
5 
Us9 
Door TraceBook voel ik me dommer worden  
5 
4 
3 
2 
1 
Us10 
Ook al was er niemand in de buurt dan kon ik nog TraceBook 
goed gebruiken 
1 
2 
3 
4 
5 
 
Algemeen en gebruikerstevredenheid: 
 
 
 
 
 
G1 
De checklisten in TraceBook beschikken niet over te veel 
checks.  
1 
2 
3 
4 
5 
G2 
Ik zou willen dat TraceBook ook buiten deze studie om 
beschikbaar zou blijven. 
1 
2 
3 
4 
5 
G3 
TraceBook is een aanvulling op het huidige elektronische 
patiëntdossier. 
1 
2 
3 
4 
5 
G4 
Ik vind het prettig dat TraceBook automatisch checks kan 
afvinken. 
1 
2 
3 
4 
5 
G5 
De checklists in TraceBook genereren correcte relevante 
checks voor de patiënten. 
1 
2 
3 
4 
5 
G7 
Over het geheel ben ik tevreden over TraceBook.  
1 
2 
3 
4 
5 
G8 
Ik geef de TraceBook een:    (1-5)