Department of Medicine, Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA
Clinical and Translational Research Accelerator, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.
BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.
To determine whether electronic health record alerts for acute kidney injury would improve patient outcomes of mortality, dialysis, and progression of acute kidney injury.
Double blinded, multicenter, parallel, randomized controlled trial.
Six hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers.
6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria.
An electronic health record based "pop-up" alert for acute kidney injury with an associated acute kidney injury order set upon provider opening of the patient's medical record.
A composite of progression of acute kidney injury, receipt of dialysis, or death within 14 days of randomization. Prespecified secondary outcomes included outcomes at each hospital and frequency of various care practices for acute kidney injury.
6030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% confidence interval 0.93 to 1.13, P=0.67). Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006). More deaths occurred at these centers (15.6% in the alert group 8.6% in the usual care group, P=0.003). Certain acute kidney injury care practices were increased in the alert group but did not appear to mediate these outcomes.
Alerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of effect across clinical centers should lead to a re-evaluation of existing alerting systems for acute kidney injury.
ClinicalTrials.gov NCT02753751.
确定电子病历急性肾损伤警报是否会改善患者的死亡率、透析和急性肾损伤进展的结局。
双盲、多中心、平行、随机对照试验。
美国康涅狄格州和罗得岛州耶鲁纽黑文卫生系统的六家医院(四家教学医院和两家非教学医院),从小型社区医院到大型三级护理中心不等。
6030 名患有急性肾损伤的成年住院患者,根据肾脏疾病:改善全球结局(KDIGO)肌酐标准定义。
基于电子病历的“弹出”急性肾损伤警报,并在提供者打开患者病历时提供急性肾损伤医嘱集。
随机分组后 14 天内急性肾损伤进展、接受透析或死亡的复合结局。预先指定的次要结局包括每家医院的结局以及急性肾损伤各种治疗方法的频率。
6030 例患者在 22 个月内随机分组。主要结局发生在 3059 例有警报的患者中的 653 例(21.3%)和 2971 例接受常规护理的患者中的 622 例(20.9%)(相对风险 1.02,95%置信区间 0.93 至 1.13,P=0.67)。按每家医院进行分析,在两所非教学医院(n=765,13%)中结局较差,警报与主要结局的风险增加相关(相对风险 1.49,95%置信区间 1.12 至 1.98,P=0.006)。这些中心的死亡人数更多(警报组为 15.6%,常规护理组为 8.6%,P=0.003)。在警报组中,某些急性肾损伤治疗方法增加,但似乎并未介导这些结局。
在患有急性肾损伤的住院患者中,警报并未降低主要结局的风险。临床中心之间的效应异质性应导致对现有的急性肾损伤警报系统进行重新评估。
ClinicalTrials.gov NCT02753751。