Testing a communication protocol 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
This study is testing a new way for surgeons to communicate during operations to see if it helps patients recover better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 13 sites (Innsbruck and 12 other locations) |
| Trial ID | NCT05356962 on ClinicalTrials.gov |
What this trial studies
This study evaluates the StOP?-protocol, a structured communication briefing led by surgeons during operations, aimed at improving post-operative outcomes. Surgeons will be randomly assigned to either implement the StOP?-protocol or continue with their usual communication methods. The effectiveness of this protocol will be assessed by comparing patient outcomes between the two groups. The goal is to enhance team communication and address potential issues proactively during surgery.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing surgery performed by board-certified surgeons participating in the study.
Not a fit: Patients whose surgeries are performed by surgeons already using the StOP?-protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could lead to improved patient outcomes and reduced post-operative mortality rates.
How similar studies have performed: Previous studies on structured communication in surgical settings have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Innsbruck and 12 other locations
- Tirol Kliniken GmbH — Innsbruck, Austria (Recruiting)
- Kantonsspital Baselland — Liestal, Basel-Landschaft, Switzerland (Recruiting)
- Kantonsspital Baden AG — Baden, Canton of Aargau, Switzerland (Active_not_recruiting)
- Bern University Hospital (Inselspital) — Bern, Canton of Bern, Switzerland (Active_not_recruiting)
- Hôpital Fribourgeois — Fribourg, Canton of Fribourg, Switzerland (Active_not_recruiting)
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Active_not_recruiting)
- Spital Limmattal — Schlieren, Canton of Zurich, Switzerland (Active_not_recruiting)
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (Active_not_recruiting)
- Stadtspital Zürich Triemli — Zurich, Canton of Zurich, Switzerland (Active_not_recruiting)
- EOC Civico Lugano and EOC ospedale regionale di Bellinzona — Lugano, Canton Ticino, Switzerland (Recruiting)
- Kantonsspital Graubünden — Chur, Kanton Graubünden, Switzerland (Active_not_recruiting)
- Spital Thurgau — Frauenfeld, Thurgau, Switzerland (Active_not_recruiting)
- Réseau hospitalier neuchâtelois — Neuchâtel, Switzerland (Active_not_recruiting)
Study contacts
- Principal investigator: Guido Beldi, MD — Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
- Study coordinator: Guido Beldi, MD
- Email: guido.beldi@insel.ch
- Phone: +41 31 63 2 48 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.