TraceBook: the Clinical Proof of Concept on the Intensive Care.
NCT ID: NCT03599856
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
408 participants
INTERVENTIONAL
2018-06-02
2019-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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"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)
No interventions assigned to this group
"After" Intervention group
An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.
TraceBook
TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.
Interventions
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TraceBook
TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All admitted patients on the ICU during the study periods.
Exclusion Criteria
ALL
No
Sponsors
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Eindhoven University of Technology
OTHER
Philips Electronics Nederland B.V. acting through Philips CTO organization
INDUSTRY
Catharina Ziekenhuis Eindhoven
OTHER
Responsible Party
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Ashley De Bie
Physician-scientist
Principal Investigators
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Erik Korsten, Prof MD
Role: STUDY_DIRECTOR
Catharina Ziekenhuis Eindhoven
Locations
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Catharina Hospital
Eindhoven, North Brabant, Netherlands
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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nWMO-2018.61
Identifier Type: -
Identifier Source: org_study_id
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