Background

National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety.

Methods

Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care.

Results

Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: ‘discharge from recovery room’ (+16%; 95% confidence interval [CI], 9–23%). This stop moment was related to decreased mortality (–3%; 95% CI, –4% to –1%), fewer complications (–8%; 95% CI, –13% to –3%), and fewer unscheduled transfers to the ICU (–6%; 95% CI, –9% to –3%). IMPROVE negatively affected one other stop moment – ‘discharge from the hospital’ – possibly because of the limited resources of hospitals to improve all stop moments together.

Conclusions

Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics.

Clinical trial registration

NTR3568 (Dutch Trial Registry).

中文翻译：

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增加对围手术期安全指南的遵守与改善患者安全结果相关：阶梯楔形、集群随机多中心试验

背景

荷兰国家指南已被引入以改善次优的围手术期护理。已经制定了一个多方面的实施计划 (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) 以支持医院应用这些指南。本研究评估了 IMPROVE 对指南依从性的有效性以及指南依从性与患者安全之间的关联。

方法

九家医院参与了这项针对非心脏大手术（死亡风险≥1%）患者的非盲、优势、阶梯楔形、集群随机对照试验。IMPROVE 包括教育活动、审核和反馈、提醒、组织、团队指导和以患者为中介的活动。该研究的主要结果是通过九个患者安全指标衡量的指南依从性（复合 STOP 束的停止时刻，以及抗生素的及时给药）和围手术期护理结构。次要安全结局包括院内并发症、术后伤口感染、死亡率、住院时间和计划外护理。

结果

对 1934 名患者的数据进行了分析。IMPROVE 程序改进了一站式服务：“从恢复室出院”（+16%；95% 置信区间 [CI]，9–23%）。这一停止时刻与死亡率降低（–3%；95% CI，–4% 至 –1%）、并发症减少（–8%；95% CI，–13% 至 –3%）和计划外转移减少有关ICU（–6%；95% CI，–9% 至 –3%）。IMPROVE 对另一个停止时刻产生了负面影响——“出院”——可能是因为医院的资源有限，无法一起改善所有停止时刻。

结论

发现了 IMPROVE 的混合实施效果。除了及时使用抗生素外，我们发现指南依从性与患者安全（即死亡率、并发症和计划外转入 ICU）之间存在一些正相关。

临床试验注册

NTR3568（荷兰审判登记处）。