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临床试验/NCT07246226
NCT07246226已完成不适用

Communication in the Surgical Environment to Promote a Climate of Safety: Implementation of Evidence

Cintia Silva Fassarella1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年12月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Incidence of improved safety climate in the operating room

研究概览

简要总结

The objective of this evidence implementation is to identify whether the implementation of a surgical briefing protocol promotes the strengthening of communication in the surgical environment of safety in the operating room among the orthopedic surgery team, including nurses, nursing technicians, orthopedic surgeons, and anesthesiologists.

The main question it seeks to answer is: does the surgical briefing protocol used to promote the strengthening of communication in the surgical environment and safety culture in the operating room comply with best practices? Participants will be asked to complete a baseline audit questionnaire, participate in training on the implementation of the surgical briefing protocol, and subsequently complete a follow-up audit questionnaire.

详细描述

The aim of the study is to identify whether the implementation of a surgical briefing protocol promotes the strengthening of the 'communication in the surgical environment' domain of safety climate in the operating room. A multi-method study is proposed to be developed in the surgical center of a university hospital located in the city of Rio de Janeiro. The study will be carried out in two phases: In Phase I, a surgical briefing protocol will be developed, validated and implemented that will follow the JBI (Joanna Briggs Institute) methodology of evidence implementation. As a support for methodological rigor, the tool SQUIRE2.0 (Standards for QUalityImprovement Reporting Excellence): revised publication guidelines from a detailed consensus process will be used. Finally, Phase II will have a quantitative approach with a cross-sectional design, using the Safety Attitudes Questionnaire/Operating Room (SAQ/OR). As a support for methodological rigor, the tool Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) will be used. The population will be composed of: nurses, nursing technicians, surgeons and anesthesiologists who work in orthopedic surgery and management of the unit. Regarding sampling, for Phase I of the study, a focus group will be constituted, called a working group (WG), adopting an intentional sampling, ensuring the participation of all health professional categories that work in orthopedic surgery. The inclusion criteria will be health professionals who work at least 20 hours per week, working in orthopedic surgeries and/or managers of the surgical center. For the validation stage, professionals withhigher education with specialization in the operating room (for nursing professionals) or orthopedic surgery (for medical professionals) will be adopted as inclusion criteria, as well as professors and researchers whose lines of research are directly related to surgical communication, patient safety and safety culture. For Phase II, a non-probabilistic sampling will be adopted, the sample calculation will be performed with the aid of the EpiInfo v5.5.9 application, adopting a confidence level of 95%. For this sample, health professionals who work at least 20 hours a week, who work directly or indirectly in patient care and who have been working in the sector for at least one month will be adopted as inclusion criteria. The exclusion criteria were the professionals who will compose the focus group. It is expected to implement a surgical briefing protocol and advance in the implementation of evidence to promote the maturation of the safety culture in the operating room, fostering safer surgical care, especially in this highly specialized sector that is the operating room. In addition to encouraging future studies involving the science of implementation in safety culture, allowing research to be truly focused on the best available evidence. It is intended that the research serves as a source of data on patient safety in the surgical environment and offers an innovative model to evaluate and intervene in complex aspects of the safety culture, involving professionals and senior management in health in the surgical environment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthcare professionals who work at least 20 hours per week, directly or indirectly involved in patient care -

排除标准

  • professionals with less than 30 days of experience in the sector

研究组 & 干预措施

surgical team

Other

Participants will complete an audit questionnaire before and after the implementation of the surgical briefing protocol.

干预措施: Surgical communication training (Behavioral)

结局指标

主要结局

Incidence of improved safety climate in the operating room

时间窗: From the registration period until the end of the protocol implementation, in 4 months

Quantitative data will be manually entered into a spreadsheet (Microsoft Excel®) and subsequently imported into the R program, version 4.2.1. The analysis will be performed using descriptive statistics (absolute and relative frequency) and mean and standard deviation. Blank items and "not applicable" items will be excluded from the analysis, as will questionnaires with the same answer to all questions. An improvement is considered if the mean is 75 or higher.

次要结局

未报告次要终点

研究者

发起方
Cintia Silva Fassarella
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cintia Silva Fassarella

Doctor

Rio de Janeiro State University

研究点 (1)

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