Communication, Multidisciplinary, Communication Research
Conditions
Keywords
Communication, Briefing, Intervention, Operating room, Surgery
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.
Interventions
BEHAVIORALStOP?-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).
Sponsors
Insel Gruppe AG, University Hospital Bern
Swiss National Science Foundation
University of Bern
Fachhochschule Nordwestschweiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will be blind whether the patients were operated by a surgeon in the control or in the intervention group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality within 30 days after the operation | 30 days after the index operation | Mortality within 30 days after the operation in the intervention arm compared to the control arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned reoperations within 30 days after the operation | 30 days after the index operation | Unplanned reoperations within 30 days after the operation in the intervention arm compared to the control arm |
| Length of hospital stay | It is reasonable to estimate that the information will be available after 60 post-operative days for most patients | Length of hospital stay in the intervention arm compared to the control arm |
| Unplanned hospital readmissions within 30 days after the operation | 30 days after the index operation | Unplanned hospital readmissions within 30 days after the operation in the intervention arm compared to the control arm |
Countries
Austria, Switzerland
Contacts
PRINCIPAL_INVESTIGATORGuido Beldi, MD
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
Outcome results
None listed