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急性肾损伤住院患者的早期个体化建议:一项随机临床试验

Early, Individualized Recommendations for Hospitalized Patients With Acute Kidney Injury: A Randomized Clinical Trial.

作者信息

Aklilu Abinet M, Menez Steven, Baker Megan L, Brown Dannielle, Dircksen Katie K, Dunkley Kisha A, Gaviria Simon Correa, Farrokh Salia, Faulkner Sophia C, Jones Charles, Kadhim Bashar A, Le Dustin, Li Fan, Makhijani Amrita, Martin Melissa, Moledina Dennis G, Coronel-Moreno Claudia, O'Connor Kyle D, Shelton Kyra, Shvets Kristina, Srialluri Nityasree, Tan Jia Wei, Testani Jeffrey M, Corona-Villalobos Celia P, Yamamoto Yu, Parikh Chirag R, Wilson F Perry

机构信息

Clinical and Translational Research Accelerator, Yale University, New Haven, Connecticut.

Section of Nephrology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.

出版信息

JAMA. 2024 Dec 24;332(24):2081-2090. doi: 10.1001/jama.2024.22718.

Abstract

IMPORTANCE

Acute kidney injury (AKI) is a common complication during hospitalization and is associated with adverse outcomes.

OBJECTIVE

To evaluate whether diagnostic and therapeutic recommendations sent by a kidney action team through the electronic health record improve outcomes among patients hospitalized with AKI compared with usual care.

DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 7 hospitals in 2 health systems: in New Haven, Bridgeport, New London, and Waterbury, Connecticut, and Westerly, Rhode Island; and in Baltimore, Maryland. Hospitalized patients with AKI were randomized between October 29, 2021, and February 8, 2024. Final follow-up occurred February 22, 2024.

INTERVENTION

An alert about AKI was sent to the kidney action team, consisting of a study physician and study pharmacist, which sent personalized recommendations through the electronic health record in 5 major categories (diagnostic testing, volume, potassium, acid base, and medications) within 1 hour of AKI detection. The note was immediately visible to anyone with access to the electronic health record. Randomization to the intervention or usual care occurred after the recommendations were generated, but the note was only delivered to clinicians of patients randomized to the intervention group.

MAIN OUTCOMES AND MEASURES

The primary outcome was a composite outcome consisting of AKI progression to a higher stage of AKI, dialysis, or mortality occurring while the patient remained hospitalized and within 14 days from randomization.

RESULTS

Of the 4003 patients randomized (median age, 72 years [IQR, 61-81 years), 1874 (47%) were female and 931 (23%) were Black patients. The kidney action team made 14 539 recommendations, with a median of 3 (IQR, 2-5) per patient. The primary outcome occurred in 19.8% of the intervention group and in 18.4% in the usual care group (difference, 1.4%, 95% CI, -1.1% to 3.8,% P = .28). Of 6 secondary outcomes, only 1 secondary outcome, rates of recommendation implementation, significantly differed between the 2 groups: 2459 of 7270 recommendations (33.8%) were implemented in the intervention group and 1766 of 7269 undelivered recommendations (24.3%) were implemented in the usual care group within 24 hours (difference, 9.5%; 95% CI, 8.1% to 11.0%).

CONCLUSIONS AND RELEVANCE

Among patients hospitalized with AKI, recommendations from a kidney action team did not significantly reduce the composite outcome of worsening AKI stage, dialysis, or mortality, despite a higher rate of recommendation implementation in the intervention group than in the usual care group.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04040296.

摘要

重要性

急性肾损伤(AKI)是住院期间的常见并发症,且与不良结局相关。

目的

评估肾脏行动小组通过电子健康记录发送的诊断和治疗建议与常规护理相比,是否能改善AKI住院患者的结局。

设计、设置和参与者:在两个医疗系统的7家医院进行的随机临床试验:位于康涅狄格州纽黑文、布里奇波特、新伦敦和沃特伯里以及罗德岛韦斯特利;以及马里兰州巴尔的摩。2021年10月29日至2024年2月8日期间,将住院的AKI患者随机分组。最终随访于2024年2月22日进行。

干预措施

向由一名研究医生和一名研究药剂师组成的肾脏行动小组发送AKI警报,该小组在检测到AKI后1小时内通过电子健康记录发送5大类(诊断检测、容量、钾、酸碱和药物)的个性化建议。任何有权访问电子健康记录的人都能立即看到该记录条。在生成建议后将患者随机分配至干预组或常规护理组,但该记录条仅发送给随机分配至干预组患者的临床医生。

主要结局和测量指标

主要结局是一个复合结局,包括在患者住院期间及随机分组后14天内发生的AKI进展至更高阶段、透析或死亡。

结果

在4003名随机分组的患者中(中位年龄72岁[四分位间距,61 - 81岁]),1874名(47%)为女性,931名(23%)为黑人患者。肾脏行动小组提出了14539条建议,每位患者的中位数为3条(四分位间距,2 - 5条)。干预组中19.8%的患者出现主要结局,常规护理组中为18.4%(差异为1.4%,95%置信区间,-1.1%至3.8%,P = 0.28)。在6个次要结局中,只有1个次要结局,即建议实施率,在两组之间有显著差异:干预组7270条建议中的2459条(33.8%)在24小时内得到实施,常规护理组未发送的7269条建议中的1766条(24.3%)在24小时内得到实施(差异为9.5%;95%置信区间,8.1%至11.0%)。

结论和相关性

在AKI住院患者中,尽管干预组的建议实施率高于常规护理组,但肾脏行动小组的建议并未显著降低AKI病情恶化、透析或死亡的复合结局。

试验注册

ClinicalTrials.gov标识符:NCT04040296。

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