STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
Disqualifiers
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).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
StOP?-protocol
BehavioralThe 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).
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mortality within 30 days after the operation
Mortality within 30 days after the operation in the intervention arm compared to the control arm
Time frame
30 days after the index operationSecondary outcomes
1
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
Time frame
30 days after the index operation2
Length of hospital stay
Length of hospital stay in the intervention arm compared to the control arm
Time frame
It is reasonable to estimate that the information will be available after 60 post-operative days for most patients3
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
Time frame
30 days after the index operationOther outcomes
1
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
Time frame
30 days after the index operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss National Science Foundation
Collaborator
University of Bern
Collaborator
Fachhochschule Nordwestschweiz
Collaborator
Source ClinicalTrials.gov