Center for Health Services and Outcomes Research, Institute of Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Department of Surgery, Feinberg School of Medicine, Northwestern Quality Improvement, Research, & Education in Surgery, Northwestern University, Chicago, Illinois.
Department of Surgery, Feinberg School of Medicine, Northwestern Quality Improvement, Research, & Education in Surgery, Northwestern University, Chicago, Illinois.
J Surg Res. 2024 Oct;302:469-475. doi: 10.1016/j.jss.2024.07.087. Epub 2024 Aug 20.
Variability in implementation of enhanced recovery protocols (ERPs) often reduces the effects of an intervention on clinical outcomes. This study aimed to evaluate hospital-level implementation fidelity to a pediatric gastrointestinal surgery ERP by assessing site-specific implementation materials.
This document analysis study operationalized implementation fidelity as adherence to the creation of specified materials at each study site. During the 12-mo implementation phase within the stepped-wedge cluster randomized control trial, ENhanced Recovery In CHildren Undergoing Surgery, study sites were provided with materials (e.g., order sets), access to peer-counseling, and given key ERP elements spanning multiple phases of care. Sixteen of the 18 total study sites submitted implementation materials, including 14 anesthesia protocols, 11 order sets, and 16 sets of patient/family education materials. These materials were assessed and graded for fidelity using prespecified criteria. Hospital-level fidelity scores could range from 0 to a maximum score of 18, and were categorized as either high or low, based on whether the score was above or below/equal to the median. Descriptive statistics and Wilcoxon rank sum test were used for analysis.
The overall hospital-level median fidelity score for inclusion of ERP elements in the implementation materials was 10.5. The median score was 12.8 at nine high-fidelity sites and was 5.6 at nine low-fidelity sites (P < 0.01). Higher adherence was noted for avoiding prolonged fasting (n = 16/18 hospitals; 89%) and preventing nausea and vomiting (n = 16/18 hospitals; 89%) in anesthesia protocols and/or order sets. Lower adherence was noted for incorporation of minimally invasive surgical techniques (n = 2/18 hospitals, 11%) and of preoperative optimization of medical comorbidities (n = 0/18 hospitals, 0%) in implementation materials.
Despite substantial resources to promote ERP elements, there was wide variation in fidelity for incorporating ERPs into implementation materials among hospital sites. Development of high-fidelity implementation materials for complex ERPs for gastrointestinal surgery in children may require longer than 12 months. Additional implementation strategies, resources, and modification of implementation-focused materials may be needed.
增强恢复方案(ERPs)的实施存在差异,这往往会降低干预措施对临床结果的影响。本研究旨在通过评估特定于站点的实施材料,评估儿科胃肠外科 ERP 的医院级实施保真度。
本文件分析研究将实施保真度操作化为在每个研究站点创建特定材料的依从性。在这项强化康复在小儿外科手术中的研究的 12 个月实施阶段,研究站点提供了材料(例如,医嘱集),并获得了同行咨询,并提供了跨越多个护理阶段的关键 ERP 要素。18 个研究站点中有 16 个提交了实施材料,包括 14 个麻醉方案、11 个医嘱集和 16 套患者/家属教育材料。使用预定标准评估和分级这些材料的保真度。医院级保真度评分范围可以从 0 到 18 分的最高分,根据评分是否高于或低于/等于中位数,分为高或低。使用描述性统计和 Wilcoxon 秩和检验进行分析。
纳入实施材料中 ERP 要素的整体医院级中位数保真度评分为 10.5。在 9 个高保真度站点的中位数评分为 12.8,在 9 个低保真度站点的中位数评分为 5.6(P<0.01)。在麻醉方案和/或医嘱集中,避免长时间禁食(n=16/18 家医院;89%)和预防恶心和呕吐(n=16/18 家医院;89%)的依从性更高。在实施材料中纳入微创技术(n=18 家医院中的 2 家,11%)和术前优化医疗合并症(n=18 家医院中 0 家,0%)的依从性较低。
尽管投入了大量资源来推广 ERP 要素,但各医院站点在将 ERP 纳入实施材料方面的保真度存在很大差异。为儿童胃肠外科的复杂 ERP 开发高保真实施材料可能需要超过 12 个月的时间。可能需要额外的实施策略、资源和实施重点材料的修改。