Verholen Nina, Vogt Lina, Klasen Martin, Schmidt Michelle, Beckers Stefan, Marx Gernot, Sopka Saša
Department of Anaesthesiology, Medical Faculty, University Hospital Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.
AIXTRA-Competence Center for Training and Patient Safety, Medical Faculty, Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.
Front Med (Lausanne). 2021 Apr 20;8:661343. doi: 10.3389/fmed.2021.661343. eCollection 2021.
Clinical handovers have been identified as high-risk situations for medical treatment errors. It has been shown that handover checklists lead to a reduced rate of medical errors and mortality. However, the influence of handover checklists on essential patient outcomes such as prevalence of sepsis, mortality, and length of hospitalization has not yet been investigated in a randomized controlled trial (RCT). The aim of the present pilot study was to estimate the effect of two different handover checklists on the 48 h sepsis-related organ failure assessment (SOFA) score and the feasibility of a respective clinical RCT. Outcome parameters and feasibility were investigated implementing and comparing an intervention with a control checklist. Single center two-armed cluster randomized prospective crossover pilot study. The study took place over three 1-month periods in an intensive care unit (ICU) setting at the University Hospital Aachen. Data from 1,882 patients on seven ICU wards were assessed, of which 1,038 were included in the analysis. A digital standardized handover checklist (ISBAR) was compared to a control checklist (VICUR). Primary outcome was the 2nd 24 h time window sepsis-related organ failure assessment (SOFA) score. Secondary outcomes were SOFA scores on the 3rd and 5th 24 h time window, mortality, reuptake, and length of stay; handover duration, degree of satisfaction, and compliance as feasibility-related outcomes. Different sepsis scores were observed only for the 1st 24 h time window after admission to the ICU, with higher values for ISBAR. With respect to the patient-centered outcomes, both checklists achieved similar results. Average handover duration was shorter for VICUR, whereas satisfaction and compliance were higher for ISBAR. However, overall compliance was low (25.4% for ISBAR and 15.8% for VICUR). Based on the results, a stratified randomization procedure is recommended for following RCTs, in which medical treatment errors should also be investigated as an additional variable. The use of control checklists is discouraged due to lower acceptance and compliance among healthcare practitioners. Measures should be undertaken to increase compliance with the use of checklists. Clinical outcome parameters should be carefully selected. ClinicalTrials.gov, Identifier [NCT03117088]. Registered April 14, 2017.
临床交接班已被确定为医疗失误的高风险环节。研究表明，交接班检查表可降低医疗失误率和死亡率。然而，在随机对照试验（RCT）中，尚未对交接班检查表对脓毒症患病率、死亡率和住院时长等关键患者预后指标的影响进行研究。本初步研究的目的是评估两种不同的交接班检查表对48小时脓毒症相关器官功能衰竭评估（SOFA）评分的影响以及相应临床RCT的可行性。通过实施并比较干预组与对照检查表来研究结果参数和可行性。单中心双臂整群随机前瞻性交叉初步研究。该研究在亚琛大学医院的重症监护病房（ICU）环境中进行，为期三个月，每月为期1个月。评估了7个ICU病房1882例患者的数据，其中1038例纳入分析。将数字标准化交接班检查表（ISBAR）与对照检查表（VICUR）进行比较。主要结局是第2个24小时时间段的脓毒症相关器官功能衰竭评估（SOFA）评分。次要结局是第3个和第5个24小时时间段的SOFA评分、死亡率、再入院率和住院时长；交接班时长、满意度和依从性作为与可行性相关的结局。仅在入住ICU后的第1个24小时时间段观察到不同的脓毒症评分，ISBAR的值更高。就以患者为中心的结局而言，两种检查表取得了相似的结果。VICUR的平均交接班时长较短，而ISBAR的满意度和依从性较高。然而，总体依从性较低（ISBAR为25.4%，VICUR为15.8%）。基于研究结果，建议在后续的RCT中采用分层随机化程序，其中还应将医疗失误作为一个额外变量进行研究。由于医护人员的接受度和依从性较低，不建议使用对照检查表。应采取措施提高对检查表使用的依从性。应谨慎选择临床结局参数。ClinicalTrials.gov标识符 [NCT03117088]。于2017年4月14日注册。
