NCT05356962

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The StOP?-protocol is a communication briefing initiated by the responsible surgeon during a surgical operation. The surgeon informs the team present in the operating room about the current Status of the operation, the Objectives of the next steps and the potential Problems the surgical team may meet; the responsible surgeon encourages the team to voice any question or concern (?). To test the impact of the StOP?-protocol on patient outcomes, the study is designed as a randomized controlled trial. Surgeons will be randomized either (a) in the intervention group and be trained to perform the StOP?-protocol or (b) in the control group and will communicate as they prefer during their operations. Post-operative patient outcomes of the surgeons in the intervention and the control group will be compared to evaluate the effects of the StOP?-protocol.

Conditions

• Communication Research
• Communication, Multidisciplinary

Interventions

Type	Name	Description
BEHAVIORAL	StOP?-protocol	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).

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2022-05-02
• Last updated: 2025-11-18

Locations

13 sites across 2 countries: Austria, Switzerland