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Набира участници Не е приложимо NCT07396675

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Stress Resilience Psychological Safety Burnout, Healthcare Workers Teamwork

Спонсор: ORNND - Operating Room Nurse Network Denmark

Налично на: БГ
Обобщение
This study is enrolled in the European KEEPCARING Project. KEEPCARING aims to (re-)build wellbeing and resilience of healthcare workforce in EU hospitals by co-creating a multi-faceted non-digital, digital, and AI-supported solution package to prevent burnout among (aspirant) healthcare professionals on the individual, team, and organizational level. This study specifically investigate the operating room staff wellbeing and resilience. The healthcare system is currently struggling to retain and attract operating room personnel. A factor of importance to consider here is occupational stress. If not recognized or mitigated well, occupational stress and personal efficacy can eventually evolve into a syndrome labelled as 'burnout'. In addition, communication and resilience patterns between operating room staff members are of influence, poor and/or inadequate communication among staff may be a factor of stress, compromising their work and wellbeing. In contrast, communication patterns that have a high standard and clarity may support resilience. The ability to speak up and being able to advocate concerns of all team members is of the highest importance here. Indeed, psychological safety and effective teamwork patterns are key for the working environment, performance, patient safety, and job satisfaction. To prevent mistakes during surgery, a safe space where team members can freely speak up is vital. To improve psychological safety, and teamwork among OR staff, team debriefing after surgery is known to be effective. What is not known; is whether team debriefing with the additional support derived from audio- and video recordings of the surgery is equally effective as debriefing without. The objective of this study is to evaluate the impact of structured postoperative debriefings with and without procedural, structured audio- and video recordings, on team performance, psychological safety, and non-technical skills in the operating room. Specifically, this study aims to compare augmented debriefings with non-augmented debriefings, to assess differences in perceived usefulness, psychological safety, and observed improvements in teams' non-technical skills. This is an international quasi-experimental comparative study. The intervention consists of postoperative team debriefing using audio and video recordings ('augmented debriefing') from Operating Room Black Box system provided by Surgical Safety Technologies. The control group will have a postoperative team debriefing that is not augmented with Operating Room Black Box derived data. An identical debriefing template will be designed for both groups.
Описание
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 a
Кой може да участва
Inclusion Criteria: * Participants work in an OR-team at RIGS, AUMC or UKE. * Participants must have given informed written consent to participate in the study. * Participants must be in the OR for the majority of the procedure or/and have a central role in the teamwork. * At RIGS and AUMC participants for the ORBB debriefings must also be part of teams conducting surgeries in the OR where ORBB is installed (not all ORs have ORBB). * Participants can either be surgeons, anesthesiologist, anesthesia nurses, residents, OR-nurses, perfusionists, interns, nurse students or other OR-staff. Exclusion Criteria: * Visitors, guests, and other staff only watching the surgery, are excluded from participation. * Individuals who are unable or unwilling to provide written informed consent.
Интервенции
Debriefing
BEHAVIORAL
Места на провеждане 3
Дания (1)
Copenhagen University Hospital, Denmark
Copenhagen
Johanne Søborg Hartmann, RN, MScN
Германия (1)
University Hospital UKE
Hamburg
NOT_YET_RECRUITING
Laetitia Hampe, MD
Нидерландия (1)
University Hospital AUMC
Amsterdam
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.03.2026
Крайна дата
01.10.2027
Регистрационен номер
NCT07396675
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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