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

Catharina Hospital

Status: Unknown

Conditions: Critical Illness; Safety Issues

Treatments: Other: TraceBook

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03599856

nWMO-2018.61

Details and patient eligibility

About

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.

Full 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.

Enrollment: 408 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Physicians objecting participation in the trial

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

"Before" control group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: TraceBook