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CompletedNCT07189481TTOCUpdated Sep 24, 2025

Design and Evaluation of a Team Timeout Checklist (TTOC) to Improve Information Exchange in the Operating Room Before Skin Incision

An observational study in Checklist, Teamwork and Information Exchange, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by University of Jena · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
151
Ages
18 Years to 65 Years
Sex
All
01

Study summary

In this study, we designed and evaluated a team timeout checklist (TTOC) which aimed at improving team communication and information exchange before skin incision. The WHO surgical safety checklist was used as a basis with the following changes: we clarified the wording of specific items (e.g., surgical site), we clarified checks by denoting separate items involved for each check, and we denoted circulating nurses as responsible for checklist readout and adherence.

02

Conditions studied

  • Checklist
  • Teamwork
  • Information Exchange

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Keywords

  • checklist
  • timeout
  • teamwork
  • communication
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

OR personnel working in orthopedics and traumatology: surgeons, anesthesiologists, anesthesia nurses, circulating nurses, technical support staff

Eligibility criteria

Inclusion Criteria: Personnel working in the operating room (nurses, surgeons, anesthesiologists, technical support staff)

-

Exclusion Criteria:

  • anyone who did not give their oral consent to be observed during surgeries
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
151 participants (actual)
Patient registry
No

Groups and cohorts

  • pre-post intervention study

    teams were observed before and after checklist use

05

What researchers measure

Primary outcomes

  1. information exchange

    this measure assessed whether all sub-items on the TTOC were adequately checked and respective information audibly shared in the team

    Time frame: from the time patients were rolled into the OR until skin incision

  2. team communication

    using a validate coding scheme, we assessed how team members communicated with each other using professional coding software to log a set of ten behaviors (e.g., instructions, questions, confirmations, speaking up...)

    Time frame: from the time patients were rolled into the OR until skin incision

Secondary outcomes

  1. duration of pre skin incision period with and without checklist

    to assess how long the period before incision takes with and without TTOC

    Time frame: from the time patients were rolled into the OR until skin incision

06

Study locations

1 site
  • University Hospital Leipzig
    Leipzig, Germany
07

Registry details

Key details

Study ID
NCT07189481
Lead sponsor
University of Jena
Collaborators
University of Leipzig
Responsible party
Mona Weiss (Professor Mona Weiss, PhD, University of Jena) — Principal investigator
First posted
Sep 24, 2025
Start date
Aug 1, 2024
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Sep 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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