ChecklistTTOCNCT07189481
Design and Evaluation of a Team Timeout Checklist (TTOC) to Improve Information Exchange in the Operating Room Before Skin Incision
An observational study of Checklist and Teamwork, run by University of Jena at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Checklist, Teamwork, Information Exchange
- How many people
- 151 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OR personnel working in orthopedics and traumatology: surgeons, anesthesiologists, anesthesia nurses, circulating nurses, technical support staff
Who may be able to join
None listed.
Who cannot join
- anyone who did not give their oral consent to be observed during surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Einer Team Time-out Checkliste im OP
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.
- Conditions
- Checklist, Teamwork, Information Exchange
- Keywords
- checklist, timeout, teamwork, communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pre-post intervention study | teams were observed before and after checklist use |
What is being measured
The primary outcome is the main question the study is designed to answer.
information exchange
this measure assessed whether all sub-items on the TTOC were adequately checked and respective information audibly shared in the team
Measured: 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...)
Measured: 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
Measured: from the time patients were rolled into the OR until skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Aug 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChecklistStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig
- Responsible party
- Principal investigator, Mona Weiss, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189481
- Sponsor's protocol ID
- University of Leipzig Ethics
- Acronym
- TTOC
- Status last verified
- Jun 2024
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Einer Team Time-out Checkliste im OP
- ClinicalTrials.gov ID
- NCT07189481
- Acronym / sponsor ID
- TTOC / University of Leipzig Ethics
- Conditions
- Checklist, Teamwork, Information Exchange
- Keywords
- checklist, timeout, teamwork, communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- University of Leipzig
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-post intervention study | – | –teams were observed before and after checklist use |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OR personnel working in orthopedics and traumatology: surgeons, anesthesiologists, anesthesia nurses, circulating nurses, technical support staff
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- anyone who did not give their oral consent to be observed during surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
information exchange
Time frame: from the time patients were rolled into the OR until skin incision
this measure assessed whether all sub-items on the TTOC were adequately checked and respective information audibly shared in the team
team communication
Time frame: from the time patients were rolled into the OR until skin incision
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...)
1 secondary outcome
duration of pre skin incision period with and without checklist
Time frame: from the time patients were rolled into the OR until skin incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Checklist and Teamwork, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
information exchange (time frame: from the time patients were rolled into the OR until skin incision). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.