STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room
Insel Gruppe AG, University Hospital Bern
400 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- For the clusters (surgeons)
- Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
- 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 Criteria9
- 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:
- 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
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Interventions
The StOP?-protocol is an intra-operative briefing initiated by the responsible surgeon. When performing a StOP?-protocol, the surgeons inform the team present in the operating room about the Status (St) of the operation, the Objectives (O) of the operations, the potential problems (P) they may meet and encourage the team to ask questions or voice concerns (?). The responsible surgeon announces at the team timeout when they plan to perform the StOP-protocol(s).
Locations(13)
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NCT05356962