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

NCT03599856 | Unknown

• 1 other identifier: nWMO-2018.61
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Safety Issues

Keywords

Checklist; Intensive Care Unit; Clinical decision support systems; Medical errors; Patient safety

Outcome Measures

Primary Outcomes (1)

• Checked items

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

  24 hours (each day)

Secondary Outcomes (26)

• Mortality

  9 months

• Mortality

  9 months

• Mortality

  9 months

• Length of stay

  9 months

• Ventilator days

  9 months

Study Arms (2)

"Before" control group

NO INTERVENTION

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)

"After" Intervention group

EXPERIMENTAL

An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.

Other: TraceBook

Interventions

TraceBook OTHER

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

Also known as: Dynamic clinical checklist

"After" Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Physicians objecting participation in the trial

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Eindhoven University of Technology: collaborator
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 28854530 RESULT

• 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.

  PMID: 33213832 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik Korsten, Prof MD

  Catharina Ziekenhuis Eindhoven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-scientist

Model Details: A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 26, 2018
• Study Start: June 2, 2018
• Primary Completion: February 12, 2019
• Study Completion: June 1, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

NL (1)