Clinical trial NCT05356962: STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
Official title: STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Communication Research
Communication, Multidisciplinary
Keywords: Communication
Briefing
Intervention
Operating room
Surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University of Bern
name: Fachhochschule Nordwestschweiz
First posted: 2022-05-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Mortality within 30 days after the operation
timeFrame: 30 days after the index operation
Secondary outcomes:
measure: Unplanned reoperations within 30 days after the operation
timeFrame: 30 days after the index operation
measure: Length of hospital stay
timeFrame: It is reasonable to estimate that the information will be available after 60 post-operative days for most patients
measure: Unplanned hospital readmissions within 30 days after the operation
timeFrame: 30 days after the index operation
Other outcomes:
measure: Surgical site infections (SSI) within 30 days after the index operation
timeFrame: 30 days after the index operation
Locations:
city: Innsbruck
country: Austria
facility: Tirol Kliniken GmbH
city: Bern
country: Switzerland
facility: Bern University Hospital (Inselspital)
state: BE
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
state: BL
city: Fribourg
country: Switzerland
facility: Hôpital Fribourgeois
state: FR
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: GR
city: Frauenfeld
country: Switzerland
facility: Spital Thurgau
state: Thurgau
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: ZH
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: ZH
city: Zürich
country: Switzerland
facility: Stadtspital Zürich Triemli
state: ZH
city: Neuchâtel
country: Switzerland
facility: Réseau hospitalier neuchâtelois
Study officials:
affiliation: Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
name: Guido Beldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keller S, Tschan F, Semmer NK, Trelle S, Manser T, Beldi G. StOP? II trial: cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room-study protocol. Trials. 2022 Oct 18;23(1):878. doi: 10.1186/s13063-022-06775-y.