NCT07189481

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
Last Updated

September 24, 2025

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

checklisttimeoutteamworkcommunication

Outcome Measures

Primary Outcomes (2)

  • information exchange

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

    from the time patients were rolled into the OR until skin incision

  • 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...)

    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

    from the time patients were rolled into the OR until skin incision

Study Arms (1)

pre-post intervention study

teams were observed before and after checklist use

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leipzig

Leipzig, Germany

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Mona Weiss, PhD

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 24, 2025

Study Start

August 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

September 24, 2025

Record last verified: 2024-06

Locations