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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Communication During Hospitalization About Resuscitation Trial

NCT02984124

Severe Life-limiting COPD Severe Life-limiting Heart Failure Severe Life-limiting Cirrhosis +3 more

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Patient Education at Dismissal After Surgical Procedure

NCT03815500

Wound Infection Post-Traumatic Wound Infection Wound Complication +2 more

WITHDRAWN NA

Effectiveness of the Consent Process

NCT00630136

Parental Consent

COMPLETED

Role of Pre-operative Counseling in the Surgical Patient

NCT03925961

Patient Education

TERMINATED NA

Research Participant Perception of Care Project: Part II: Fielding and Validation of the Research Participant Perception Survey Derived From Focus Group-Identified Key Dimensions of the Research Participant Experience

NCT01129869

Participation Satisfaction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Communication Research Communication, Multidisciplinary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessors will be blind whether the patients were operated by a surgeon in the control or in the intervention group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

StOP?-protocol

Intervention Type 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).

Control group

Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.

* 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

* 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:

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guido Beldi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tirol Kliniken GmbH

Innsbruck, , Austria

Site Status RECRUITING

Kantonsspital Baselland

Liestal, Basel-Landschaft, Switzerland

Site Status RECRUITING