Department of Anesthesiology, Rijnstate Hospital, Arnhem, The Netherlands.
Department of Anesthesiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Trials. 2023 Oct 11;24(1):660. doi: 10.1186/s13063-023-07685-3.
As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events.
METHODS/DESIGN: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months.
PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice.
ClinicalTrials.gov NCT05703230. Registered on 11/09/2022.
随着人们预期寿命的延长和慢性病患者护理水平的提高,需要接受手术干预的多种合并症患者数量不断增加。对于复杂的手术患者,平衡手术治疗的潜在获益与因并发症导致永久性丧失功能能力和生活质量的风险至关重要。欧洲和美国的围手术期护理指南建议对高风险非心脏手术患者进行术前多学科团队(MDT)讨论。然而,术前 MDT 会议与所有相关围手术期专业人员共同带来获益的证据有限。本研究旨在调查为高风险非心脏手术患者实施术前 MDT 讨论对严重不良事件的影响。
方法/设计:PREPARATION 是一项在 14 家荷兰医院进行的阶梯式楔形集群随机试验,这些医院目前没有建立术前 MDT 会议。干预措施,即术前 MDT 会议,将以七个块的顺序实施,每个块有 2 家医院,每 3 个月从对照组(常规术前筛查)切换到干预组。每个医院将随机分配到七个块中的一个。我们计划纳入 1200 名患者。主要结局是 6 个月时严重不良事件的发生率。次要结局包括(成本)效益、功能结局和最长 12 个月的生活质量。
PREPARATION 是第一项评估存在麻醉师时,术前 MDT 会议对高风险非心脏手术患者有效性的研究。如果结果表明术前 MDT 讨论对高风险患者是(成本)有效的,那么本研究将促进术前 MDT 会议在临床实践中的实施。
ClinicalTrials.gov NCT05703230。注册于 2022 年 9 月 11 日。