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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| University of Bern | OTHER |
| Fachhochschule Nordwestschweiz | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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. |
|
| Control group | No Intervention | Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StOP?-protocol | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Length of hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
For the clusters (surgeons)
Inclusion Criteria:
Exclusion Criteria:
For the patients:
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guido Beldi, MD | Contact | +41 31 63 2 48 18 | guido.beldi@insel.ch | |
| Sandra Keller, PhD | Contact | +41 31 66 4 21 76 | sandra.keller@dbmr.unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Guido Beldi, MD | Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tirol Kliniken GmbH | Recruiting | Innsbruck | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36258223 | Derived | 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. |
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Outcomes assessors will be blind whether the patients were operated by a surgeon in the control or in the intervention group.
|
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 |
| 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 |
| Kantonsspital Baselland | Recruiting | Liestal | Basel-Landschaft | 4410 | Switzerland |
|
| Kantonsspital Baden AG | Active, not recruiting | Baden | Canton of Aargau | 5404 | Switzerland |
| Bern University Hospital (Inselspital) | Active, not recruiting | Bern | Canton of Bern | 3008 | Switzerland |
| Hôpital Fribourgeois | Active, not recruiting | Fribourg | Canton of Fribourg | 1708 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Active, not recruiting | Lausanne | Canton of Vaud | 1000 | Switzerland |
| Spital Limmattal | Active, not recruiting | Schlieren | Canton of Zurich | 8952 | Switzerland |
| Kantonsspital Winterthur | Active, not recruiting | Winterthur | Canton of Zurich | 8400 | Switzerland |
| Stadtspital Zürich Triemli | Active, not recruiting | Zurich | Canton of Zurich | 8063 | Switzerland |
| EOC Civico Lugano and EOC ospedale regionale di Bellinzona | Recruiting | Lugano | Canton Ticino | 6900 | Switzerland |
|
| Kantonsspital Graubünden | Active, not recruiting | Chur | Kanton Graubünden | 7000 | Switzerland |
| Spital Thurgau | Active, not recruiting | Frauenfeld | Thurgau | 8501 | Switzerland |
| Réseau hospitalier neuchâtelois | Active, not recruiting | Neuchâtel | 2000 | Switzerland |
| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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