Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.

Design and setting This is an international quasi-experimental comparative study, following the guidelines for complex interventions in health. The intervention will be ORBB augmented team-debriefing after surgery. The control group will debrief after surgery without the assistance of the ORBB. An identical debriefing template has been designed for both groups.

This study will be conducted at OR departments in three university hospitals, located in three different countries: Rigshospitalet, Copenhagen University Hospital (RIGS), Amsterdam University Medical Center (AUMC) and University Medical Center Hamburg-Eppendorf (UKE). RIGS have nine OR's with ORBB installed and access to ORBB-generated video material and outcome reports using explainable AI. AUMC is expected to have two OR's with ORBB installed before beginning of study. RIGS and AUMC are planned as both interventions and control sites, AUMC will if unforeseen delays occur with ORBB installation, be a control site (e.g. have only non-augmented debriefings). UKE does not have ORBB and will be a control site.

Characteristics of the study population

Participants Full OR teams performing elective daytime surgeries, approximately 4-12 people per team. The teams will be selected from a variety of specialties such as cardiothoracic, gynecology, urology, abdominal, vascular, and orthopedic surgery. Depending on the variety and possibility at each site, RIGS, AUMC and UKE, including limitations due to which ORs have ORBB installed.

Intervention Investigators anticipate that the intervention of the study occurs over a 1-month period for each team. In total, the intervention period is scheduled over a one-year period within 2026. During all data collection team members speak in their native language, so for RIGS this is Danish, for AUMC Dutch and for UKE German. The intervention includes a baseline questionnaire, a surgery, a short questionnaire after surgery, an observed debriefing and a follow up questionnaire after surgery.

The intervention set up is the same for teams with and without ORBB, only difference is the audio and video from the ORBB and SST. Furthermore, the debriefings will be audio recorded, and a researcher will observe the sessions. After the intervention period, a sample of participants will be asked to participate in a qualitive interview study.

Preparation before team debriefing After surgery the OR team members individually fill out a short questionnaire. Team members will answer questions about the following four topics: overall procedure, teamwork, safety protocols and learning opportunities.

The key points are wide in their definitions purposely because the team members should have the possibility to choose meaningful moments from the actual OR situation within the four topics. They must answer the questionnaire within 12 hours after surgery, to secure that the OR episode is still fresh in their minds.

Afterwards the researcher on site will review the questionnaires and during non-augmented debriefings bring their answers into play. During augmented debriefings, the researcher will 'flag' the surgery within the SST platform and in collaboration with SST create 2-4 videoclips, that contains the key elements chosen by the team members.

Team debriefing The setup in both augmented and non-augmented debriefings focus on creating a dedicated learning environment that prioritizes reflection, open communication, and psychological safety during the sessions. The physical space is carefully designed to support these critical aspects of team learning and collaboration.

In every debriefing an independent educational specialist (with no formal or working relation to the OR) is used as a moderator that controls the conversation and follow the debriefing template.

During the debriefing a researcher observes the conversation and interactions between team members and the moderator. The observing researcher sits in a corner of the room, disturbing as little as possible, being quiet and only taking field notes of the interaction between the team members and the moderator. The debriefing sessions will be audio-recorded, and transcribed verbatim by the observing researcher.

The session is time-limited to 30-60 minutes, balancing comprehensive discussion with efficiency. Critically, the debriefing is ideally conducted after approximately 5 (to a maximum of 21 days) following the surgery, allowing team members sufficient time to process the experience while maintaining the immediacy of relevant insights and reflections emotionally and professionally.

At the same time, securing the researchers a timespan to overview the short questionnaires, and select key points, for the moderator to work with in the debriefing sessions. Specific for the ORBB augmented debriefings, at the same time securing a timespan for the researchers to select and prepare 2-4 videoclips within the ORBB platform in collaboration with SST before the debriefing.

Debriefing template for debriefing In this study investigators implement a six-step team debriefing model, tested with a high rate of participant satisfaction (7.8/10 rating) in a previous study on 35 ORBB augmented abdominal surgery team debriefing sessions. The researchers concluded that their proposed approach effectively facilitates OR debriefing across diverse healthcare settings and provides a viable framework for establishing a much-needed debriefing culture to enhance surgical team performance. Investigators adjusted the model with few moderations to fit both OR debriefings with and without ORBB augmented data, and to include more OR specialties, on top of abdominal OR teams.

During the debriefings the moderator controls the conversation, and every team member represents their field of expertise in the OR. The moderator follows the themes; experience, observation, analyze and application.

During the debriefings all teams will focus on psychological safety and problem solving within the following four key points: overall procedure, teamwork, safety protocols and learning opportunities. For the intervention sites, the debriefing templates are the same as the control site, only add on is the ORBB augmented material of 2-4 videoclips and objective data from SST platform, integrated into the debriefing templates.

Data and Outcomes Investigators will gather data about the debriefings and measure outcomes through the following measurement tools; observation and audio recording of team debriefings, individual pre- and post-debriefing questionnaires and qualitative interviews. Specifically for surgeries using the ORBB system, OR teams will also be observed through audio and video-review from ORBB, including AI statistical data provided by SST.

This will allow for in-depth analysis of team dynamics, providing a structured approach to understanding and improving collaborative practices in surgical settings. By capturing both quantitative ratings and qualitative insights, the research aims to develop targeted strategies that can elevate team communication, psychological safety, and overall performance.

Regulatory and ethics The coordinating hospital for this study is RIGS. In 2019, the Danish Data Protection Agency approved the overall ORBB project (registration no.: VD-2019-275). The project was submitted to the Regional Ethics Committee in 2018, and no ethical approval was needed (registration no.: H-18018801). Additional approval for this debriefing study has been obtained in 2025 from the Regional Legal and Ethics Committee in Copenhagen, Denmark, PRIVACY - legal GRC (ID-NUMBER: p-2025-19044).

Participation in this study is voluntary and thus consent based. All participants will receive oral and written information before entering the study, and they must sign a consent form to participate. Participants can withdraw their consent at any time. Data will be stored on certified servers of Zenodo, which complies with all regulations and applicable laws. Data will also be stored locally in the department's computer system drive.