Slagman Anna, Schenk Liane, Huscher Dörte, Arnold Lisa, Dormann Harald, Drepper Johannes, Eienbröker Larissa, Fischer-Rosinský Antje, Frick Johann, Helbig Lukas, Horenkamp-Sonntag Dirk, Irorutola Freddy, Klinge Tim, Reinhold Thomas, Schily Peter, Stier Britta, Verleger Katharina, Wagenknecht Andreas, Wu Yves Noel, Möckel Martin
Emergency and Acute Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, Berlin 10117, Germany.
Institute of Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, Berlin 10117, Germany.
Lancet Reg Health Eur. 2025 Jun 26;55:101362. doi: 10.1016/j.lanepe.2025.101362. eCollection 2025 Aug.
Even though abdominal pain is one of the most frequent chief complaints in emergency medicine, standardized care pathways are still lacking. In this study, a standardized, digitally-supported care pathway for non-traumatic abdominal pain in the emergency department was investigated with regard to emergency department length of treatment, pain score at discharge, and patient satisfaction.
In a prospective mixed-methods, multicentre, cluster-randomised, controlled stepped wedge trial, adult patients with non-traumatic abdominal pain were enrolled in ten emergency departments across Germany. The new care pathway was implemented at randomly assigned time points (every four months) within a 24-month recruitment period and consisted of a structured care pathway for the management of abdominal pain patients in the emergency department. During the control period, the standard treatment for abdominal pain in the emergency department was administered. The planned sample size was 2000. Primary outcomes were: emergency department length of treatment, pain score (numeric rating scale 0-10), and patient satisfaction score at the end of emergency department treatment. Exploratory safety outcomes were serious adverse events within 30 days. Trial registration: DRKS00021052.
Of 2119 patients, 1017 were enrolled in the control group, and 1102 in the intervention group. Crude mean emergency department length of treatment was 5.2 h (±3.0) in the control group, and 4.3 h (±2.2) in the intervention group while the adjusted mean difference was -0.31 h (95% confidence interval (CI) -0.70 to 0.07). Mean pain score was 4.3 (±2.5) in the control group, and 3.6 (±2.4) in the intervention group, resulting in an adjusted mean difference of -0.69 (95% CI -1.04 to -0.34). The adjusted mean difference of patient's satisfaction score was 1.54 (95% CI 0.96 to 2.12); mean control group: 26.7 (±4.0); mean intervention group: 27.9 (±3.8)). Serious adverse events were comparable between both groups while 30-day mortality was 2.3% (n = 23) in the control group, and 0.8% (n = 9) in the intervention group (mean difference: -1.4% (95% CI -2.5 to -0.4)).
The APU process is safe and did not increase emergency department length of treatment, while patient-reported outcomes and safety were improved accompanied by an increased use of diagnostic procedures.
The study was funded by the German Innovations Funds.
尽管腹痛是急诊医学中最常见的主要症状之一，但仍缺乏标准化的护理路径。在本研究中，针对急诊科非创伤性腹痛的标准化数字支持护理路径，就急诊科治疗时长、出院时疼痛评分和患者满意度进行了调查。
在一项前瞻性混合方法、多中心、整群随机对照阶梯楔形试验中，德国十个急诊科纳入了非创伤性腹痛的成年患者。新的护理路径在24个月的招募期内随机分配的时间点（每四个月）实施，包括急诊科腹痛患者管理的结构化护理路径。在对照期，采用急诊科腹痛的标准治疗方法。计划样本量为2000。主要结局指标为：急诊科治疗时长、疼痛评分（数字评分量表0 - 10）和急诊科治疗结束时的患者满意度评分。探索性安全结局指标为30天内的严重不良事件。试验注册号：DRKS00021052。
2119例患者中，1017例纳入对照组，1102例纳入干预组。对照组急诊科治疗的粗均时长为5.2小时（±3.0），干预组为4.3小时（±2.2），调整后的均差为 - 0.31小时（95%置信区间（CI） - 0.70至0.07）。对照组平均疼痛评分为4.3（±2.5），干预组为3.6（±2.4），调整后的均差为 - 0.69（95% CI - 1.04至 - 0.34）。患者满意度评分的调整后均差为1.54（95% CI 0.96至2.12）；对照组均值：26.7（±4.0）；干预组均值：27.9（±3.8））。两组严重不良事件相当，而对照组30天死亡率为2.3%（n = 23），干预组为0.8%（n = 9）（均值差异： - 1.4%（95% CI - 2.5至 - 0.4））。
APU流程是安全的，并未增加急诊科治疗时长，同时患者报告的结局和安全性得到改善，且诊断程序的使用有所增加。
该研究由德国创新基金资助。
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