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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Communication Research; Communication, Multidisciplinary

Treatments: Behavioral: StOP?-protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05356962

2021-02433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Interventional group

Experimental group

Description:

The surgeons will undergo a multi-module training on how to use the StOP?-protocol and perform the StOP?-protocol during all their operations during a 4-month period.

Treatment:

Behavioral: StOP?-protocol

Control group

No Intervention group

Description:

Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.