Pharmacie, Hôpital des Charpennes, Hospices Civils de Lyon, Villeurbanne, France.
BMC Geriatr. 2011 May 18;11:25. doi: 10.1186/1471-2318-11-25.
Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Although several interventions have proved their effectiveness to prevent it, the Cochrane advises an assessment of multifaceted intervention using rigorous methodology based on randomized study design. Our purpose is to present the methodology and expected results of the CONFUCIUS trial, which aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.
METHOD/DESIGN: Study design is a stepped wedge cluster randomized trial within 3 surgical wards of three French university hospitals. All patients aged 75 and older, and admitted for scheduled surgery will be included. The multifaceted program will be conducted by mobile geriatric team, including geriatric preoperative consultation, training of the surgical staff and implementation of the Hospital Elder Life Program, and morbidity and mortality conference related to delirium cases. The primary outcome is based on postoperative delirium rate within 7 days after surgery. This program is planned to be implemented along four successive time periods within all the surgical wards. Each one will be affected successively to the control arm and to the intervention arm of the trial and the order of program introduction within each surgical ward will be randomly assigned. Based on a 20% reduction of postoperative delirium rate (ICC = 0.25, α = 0.05, β = 0.1), three hundred sixty patients will be included i.e. thirty patients per service and per time period. Endpoints comparison between intervention and control arms of the trial will be performed by considering the cluster and time effects.
Better prevention of delirium is expected from the multifaceted program, including a decrease of postoperative delirium, and its consequences (mortality, morbidity, postoperative complications and length of hospital stay) among elderly patients. This study should allow better diagnosis of delirium and strengthen the collaboration between surgical and mobile geriatric teams. Should the program have a substantial impact on the prevention of postoperative delirium in elderly, it could be extended to other facilities.
ClinicalTrials.gov: NCT01316965.
术后谵妄在老年人中很常见，与死亡率、并发症、住院时间和长期护理机构入院率的显著增加有关。尽管有几种干预措施已被证明可有效预防术后谵妄，但考科蓝建议根据随机研究设计，使用严格的方法评估多方面的干预措施。我们的目的是介绍 CONFUCIUS 试验的方法学和预期结果，该试验旨在衡量多方面方案对预防老年患者术后谵妄的影响。
方法/设计：研究设计是在法国三家大学医院的三个外科病房内进行的逐步楔形集群随机试验。所有 75 岁及以上、因择期手术而入院的患者都将被纳入。多方面的方案将由移动老年科团队实施，包括老年术前咨询、对手术人员的培训以及实施医院老年生活方案和与谵妄病例相关的发病率和死亡率会议。主要结局是术后 7 天内术后谵妄发生率。该方案计划在所有外科病房内分四个连续阶段实施。每个阶段将依次受到试验对照组和干预组的影响，每个外科病房内方案介绍的顺序将随机分配。基于术后谵妄发生率降低 20%（ICC = 0.25，α = 0.05，β = 0.1），将纳入 360 名患者，即每个科室和每个时间段各 30 名患者。通过考虑集群和时间效应，对试验干预组和对照组的终点进行比较。
多方面的方案有望更好地预防谵妄，包括降低老年患者术后谵妄及其后果（死亡率、发病率、术后并发症和住院时间）的发生率。这项研究应该可以更好地诊断谵妄，并加强外科和移动老年科团队之间的合作。如果该方案对预防老年患者术后谵妄有实质性影响，它可以扩展到其他机构。
ClinicalTrials.gov：NCT01316965。
