STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room

Communication Research Clinical Trial

— StOP?  

Official title:

STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356962
• Other study ID #: 2021-02433
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: September 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Guido Beldi, MD
• Phone: +41 31 63 2 48 18
• Email: guido.beldi[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication Research
• Communication, Multidisciplinary

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Bern University Hospital (Inselspital)	Bern	BE
Switzerland	Hôpital Fribourgeois	Fribourg	FR
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud
Switzerland	Kantonsspital Baselland	Liestal	BL
Switzerland	Spital Limmattal	Schlieren	ZH

Sponsors (4)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Fachhochschule Nordwestschweiz, Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical site infections (SSI) within 30 days after the index operation	Surgical site infections as defined by the Centers for Disease Control and Prevention (CDC) and collected by Swissnoso (a national surveillance programme for surgical site infections in Switzerland) in the intervention arm compared to the control arm. Note. SSI will be collected only for a pragmatic subsample of patients	30 days after the index operation
Primary	Mortality within 30 days after the operation	Mortality within 30 days after the operation in the intervention arm compared to the control arm	30 days after the index operation
Secondary	Unplanned reoperations within 30 days after the operation	Unplanned reoperations within 30 days after the operation in the intervention arm compared to the control arm	30 days after the index operation
Secondary	Length of hospital stay	Length of hospital stay in the intervention arm compared to the control arm	It is reasonable to estimate that the information will be available after 60 post-operative days for most patients
Secondary	Unplanned hospital readmissions within 30 days after the operation	Unplanned hospital readmissions within 30 days after the operation in the intervention arm compared to the control arm	30 days after the index operation