背景:外科护理,这是由多学科的外科医生团队进行激烈互动,麻醉师,和护士,仍然与显著的发病率和死亡率相关。术中沟通已被证明与手术结果相关,但缺乏确保术中有效沟通的工具。在之前的研究中,我们开发了StOP?-协议,促进结构化的术中通信。在手术的关键阶段之前,负责的外科医生发起并领导一个或多个StOP?在停顿期间?外科医生告知手术进展(状态),下一步和近端目标(目标),和可能的问题(problems),并鼓励所有团队成员发表他们的意见并提出问题(?)。在一项主要在内脏手术中进行的前后研究中,我们发现了StOP?-方案对死亡率的影响,住院时间,再操作。我们打算在整群随机试验中评估StOP?协议的影响,在更广泛的外科专业中(即,一般,内脏,胸廓,血管手术,外科泌尿外科,和妇科)。主要假设是,主要外科医生一致使用StOP?协议可在术后30天内降低患者死亡率。次要假设是,主要外科医生一致使用StOP?-协议减少了计划外的再次手术。住院时间,和计划外的医院再入院。
方法:本研究设计为多中心,整群随机平行组试验。参与的临床部门的董事会认证的外科医生将以1:1的比例随机分配到StOP?干预组或标准护理(对照)组。干预组将接受使用StOP?协议的培训,并定期收到有关其遵守协议的反馈。对照组的外科医生将在手术过程中照常进行交流。观察单位将是由集束外科医生进行的手术。连续的患者将被纳入每个集群超过4个月。共招募400名外科医生,我们预计将收集14,000例外科手术的患者结果数据。
结论:StOP?-协议被设计为在手术过程中构建通信的工具。测试其对患者预后的影响将有助于实施基于证据的干预措施,以减少手术并发症。
背景:ClinicalTrials.govNCT05356962。2022年5月2日注册。
BACKGROUND: Surgical care, which is performed by intensely interacting multidisciplinary teams of surgeons, anesthetists, and nurses, remains associated with significant morbidity and mortality. Intraoperative communication has been shown to be associated with surgical outcomes, but tools ensuring efficient intraoperative communication are lacking. In a previous study, we developed the StOP?-protocol that fosters structured intraoperative communication. Before the critical phases of the operation, the responsible surgeon initiates and leads one or several StOP?s. During a StOP?, the surgeon informs about the progress of the operation (status), next steps and proximal goals (objectives), and possible problems (problems) and encourages all team members to voice their observations and ask questions (?). In a before-after study performed mainly in visceral surgery, we found effects of the StOP?-protocol on mortality, length of hospital stay, and reoperation. We intend to assess the impact of the StOP?-protocol in a cluster randomized trial, in a wider variety of surgical specialties (i.e., general, visceral, thoracic, vascular surgery, surgical urology, and gynecology). The primary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces patient mortality within 30 days after the operation. The secondary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces unplanned reoperations, length of hospital stay, and unplanned hospital readmissions.
METHODS: This study is designed as a multicenter, cluster-randomized parallel-group trial. Board-certified surgeons of participating clinical departments will be randomized 1:1 to the StOP? intervention group or to the standard of care (control) group. The intervention group will undergo a training to use the StOP?-protocol and receive regular feedback on their compliance with the protocol. The surgeons in the control group will communicate as usual during their operations. The unit of observation will be operations performed by cluster surgeons. Consecutive patients will be enrolled over 4 months per cluster. A total of 400 surgeons will be recruited, and we expect to collect patient outcome data for 14,000 surgical procedures.
CONCLUSIONS: The StOP?-protocol was designed as a tool to structure communication during surgical procedures. Testing its effects on patient outcomes will contribute to implementing evidenced-based interventions to reduce surgical complications.
BACKGROUND: ClinicalTrials.gov NCT05356962. Registered on May 2, 2022.