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Critical IllnessTraceBookNCT03599856

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

A study testing TraceBook in people with Critical Illness and Safety Issues, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Critical Illness, Safety Issues
What is being tested?
TraceBook
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteNetherlands
Study dates
2 Jun 2018to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Physicians working on the ICU
  • All admitted patients on the ICU during the study periods.

Who cannot join

  • Physicians objecting participation in the trial

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
TraceBook
Keywords
Checklist, Intensive Care Unit, Clinical decision support systems, Medical errors, Patient safety
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TraceBookOther

    Also called Dynamic clinical checklist

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

Study groups in NCT03599856
Study groupRoleWhat they receive
"Before" control groupNo interventionControl 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)
"After" Intervention groupExperimentalAn mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.
Receives: Other: TraceBook

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Checked items

    The percentage of daily checked checkable items overall and items requiring an intervention per patient.

    Measured: 24 hours (each day)

Secondary outcomes (26)

  1. Mortality

    Intensive Care mortality

    Measured: 9 months

  2. Mortality

    30 day mortality

    Measured: 9 months

  3. Mortality

    90 day mortality

    Measured: 9 months

  4. Length of stay

    Length of stay at the intensive care

    Measured: 9 months

  5. Ventilator days

    Number of days with use of mechanical ventilator (per patient and overall per period)

    Measured: 9 months

  6. Sedation days

    Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.

    Measured: 9 months

  7. Daily intensive care medication alerts

    Number of daily intensive care medication alerts for the pharmacist.

    Measured: 4 months

  8. Pharmacists' interventions

    Types of pharmacists' interventions based on the daily intensive care medication alerts

    Measured: 4 months

  9. Number of gastro-intestinal bleedings

    The number of patients during each period with hematemesis or melena, not being the reason of admission.

    Measured: 4 months

  10. 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.

    Measured: 4 months

  11. 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.

    Measured: 4 months

  12. Incorrect prescribed anticoagulation or thrombosis prophylaxis.

    Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.

    Measured: 4 months

  13. Incorrect prescribed proton pump inhibitors

    Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.

    Measured: 4 months

  14. Incorrect prescribed selective digestive decontamination

    Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.

    Measured: 4 months

  15. Spontaneous breathing trials

    Number of spontaneous breathing trials when required based on local protocol in weaning patients

    Measured: 4 months

  16. Sedation wake up calls

    Number of sedation wake up calls when required based on local protocol

    Measured: 4 months

  17. Intravenous sedatives use

    Number of patient days with the use of intravenous sedatives (eg Propofol, Midazolam)

    Measured: 4 months

  18. Opiates use

    Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (<4).

    Measured: 4 months

  19. Antibiotics use

    Number of patient days with the use of antibiotics overall and when not required based on local protocol.

    Measured: 4 months

  20. Complication registration

    Number of complications that were discussed within 24hrs and registered.

    Measured: 4 months

  21. Energy deficit

    Number of patient days with energy deficit of >250.

    Measured: 4 months

  22. Automatically checked items

    Number of items that where or could have been checked automatically during each period.

    Measured: 4 months

  23. User experience outcomes

    Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview

    Measured: 6 months

  24. Hedonic and pragmatic quality

    Attrakdiff questionnaire

    Measured: 6 months

  25. 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.

    Measured: 6 months

  26. User experience

    Semi-structured interview after the intervention period.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start2 Jun 2018
  3. Primary completion12 Feb 2019 (estimated)
  4. Study completion1 Jun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03599856
Sponsor's protocol ID
nWMO-2018.61
Acronym
TraceBook
Status last verified
Jan 2019
First submitted
29 Jun 2018
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD is available if researchers ask for it.

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.

    PubMed 28854530

  • 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.

    PubMed 33213832

Questions about this trial

What is this clinical trial studying?

A study testing TraceBook in people with Critical Illness and Safety Issues, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Checked items (time frame: 24 hours (each day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03599856, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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