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Completed
NCT05356962
STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
Conditions: Communication Research, Communication, Multidisciplinary
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Insel Gruppe AG, University Hospital Bern
Location: Tirol Kliniken GmbH Innsbruck
Summary
The purpose of the study is to test the impact of the StOP?-protocol - an intra-operative communication briefing, on post-operative mortality and important patient outcomes.
Eligibility Criteria
For the clusters (surgeons)
Inclusion Criteria:
* Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
Exclusion Criteria:
* Surgeons who are already performing StOP?-protocol. (Potentially, surgeons who took part in the first study (StOP-I) may still perform StOP?).
* Surgeon who were previously enrolled in the StOP?-II trial (this is relevant for surgeons who move or rotate between departments/hospitals and might therefore be working at different participating sites).
For the patients:
Inclusion criteria:
* Patients operated by cluster surgeons during the cluster-specific time period
* General consent from the patients, allowing the use of healthcare-related data that are the result of the patient's treatment. In case no written document from the general consent is available despite documented efforts of the participating center, article 34 HRA (Swiss law) will be applied, allowing the use of the healthcare-related patient data.
Exclusion criteria:
* Patient age below 18 years
* Previous operation at the same site up to 30 days prior the index operation
* Procedures not done in operating rooms but in outpatient clinics, on wards, etc.
* Mainly diagnostic endoscopic procedures (e.g. colonoscopy, gastroscopy, bronchoscopy)
* Percutaneous interventions (e.g., transurethral interventions)
* Documented refusal for the use of healthcare related data
Source: ClinicalTrials.gov (NCT05356962). StuddyBuddy aggregates publicly available trial information.