Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2025-12-24 @ 11:35 PM
NCT ID: NCT03599856
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.
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: NCT03599856
Study Brief:
Protocol Section: NCT03599856