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

STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room

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.

Study Overview

• Status: Recruiting
• Conditions: Communication Research; Communication, Multidisciplinary
• Intervention / Treatment: Behavioral: StOP?-protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guido Beldi, MD; Phone Number: +41 31 63 2 48 18; Email: guido.beldi@insel.ch
• Study Contact Backup: Name: Sandra Keller, PhD; Phone Number: +41 31 66 4 21 76; Email: sandra.keller@dbmr.unibe.ch

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3008
      • Active, not recruiting
      • Bern University Hospital (Inselspital)
  • BL
    • Liestal, BL, Switzerland, 4410
      • Recruiting
      • Kantonsspital Baselland
      • Contact: Andres Heigl, MD; Phone Number: +41619252525; Email: Andres.Heigl@ksbl.ch
  • FR
    • Fribourg, FR, Switzerland, 1708
      • Recruiting
      • Hôpital Fribourgeois
      • Contact: Melanie Kauper, MD; Phone Number: 41 26 306 25 10; Email: Melanie.Kauper@h-fr.ch
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Active, not recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
  • ZH
    • Schlieren, ZH, Switzerland, 8952
      • Recruiting
      • Spital Limmattal
      • Contact: Susanne Battilana; Phone Number: +41 44 736 8511; Email: Susanne.Battilan@spital-limmattal.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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.	Behavioral: StOP?-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).
No Intervention: Control group; Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Swiss National Science Foundation; University of Bern; Fachhochschule Nordwestschweiz
• Investigators: Principal Investigator: Guido Beldi, MD, Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Intervention; Communication; Operating room; Briefing
• Other Study ID Numbers: 2021-02433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No