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常规改进与间断或非间断式血液订单提示在改善红细胞使用率方面的比较:一项旨在提高红细胞使用率的随机对照试验研究方案

General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization.

机构信息

Division of Hospital Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, 12401 East 17Th Avenue, Mailstop F-782, Aurora, CO, 80045, USA.

Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

出版信息

Trials. 2023 May 8;24(1):314. doi: 10.1186/s13063-023-07319-8.

Abstract

BACKGROUND

Blood transfusions can serve as a life-saving treatment, but inappropriate blood product transfusions can result in patient harm and excess costs for health systems. Despite published evidence supporting restricted packed red blood cell (pRBC) usage, many providers transfuse outside of guidelines. Here, we report a novel prospective, randomized control trial to increase guideline-concordant pRBC transfusions comparing three variations of clinical decision support (CDS) in the electronic health record (EHR).

METHODS

All inpatient providers at University of Colorado Hospital (UCH) who order blood transfusions were randomized in a 1:1:1 fashion to the three arms of the study: (1) general order set improvements, (2) general order set improvements plus non-interruptive in-line help text alert, and (3) general order set improvements plus interruptive alert. Transfusing providers received the same randomized order set changes for 18 months. The primary outcome of this study is the guideline-concordant rate of pRBC transfusions. The primary objective of this study is to compare the group using the new interface (arm 1) versus the two groups using the new interface with interruptive or non-interruptive alerts (arms 2 and 3, combined). The secondary objectives compare guideline-concordant transfusion rates between arm 2 and arm 3 as well as comparing all of arms of the study in aggregate to historical controls. This trial concluded after 12 months on April 5, 2022.

DISCUSSION

CDS tools can increase guideline-concordant behavior. This trial will examine three different CDS tools to determine which type is most effective at increasing guideline-concordant blood transfusions.

TRIAL REGISTRATION

Registered on ClinicalTrials.gov 3/20/21, NCT04823273 . Approved by University of Colorado Institutional Review Board (19-0918), protocol version 1 4/19/2019, approved 4/30/2019.

摘要

背景

输血可以作为一种救命的治疗方法,但不适当的血制品输注可能会导致患者伤害和医疗系统的额外成本。尽管有发表的证据支持限制浓缩红细胞(pRBC)的使用,但许多医生仍会在指南之外进行输血。在这里,我们报告了一项新的前瞻性、随机对照试验,通过比较电子病历(EHR)中三种不同的临床决策支持(CDS)变体,来增加符合指南的 pRBC 输血。

方法

科罗拉多大学医院(UCH)所有开具输血医嘱的住院医生以 1:1:1 的比例随机分配到研究的三个组:(1)一般医嘱集改进,(2)一般医嘱集改进加非中断在线帮助文本警报,和(3)一般医嘱集改进加中断警报。输血提供者接受相同的随机医嘱集变化 18 个月。本研究的主要结果是 pRBC 输血的符合指南率。本研究的主要目的是比较使用新界面的组(组 1)与使用新界面加中断或非中断警报的两组(组 2 和 3,合并)。次要目标是比较组 2 和组 3 之间的符合指南的输血率,以及将研究的所有组与历史对照进行比较。该试验于 2022 年 4 月 5 日在 12 个月后结束。

讨论

CDS 工具可以增加符合指南的行为。本试验将研究三种不同的 CDS 工具,以确定哪种类型最能有效地增加符合指南的输血。

试验注册

于 2021 年 3 月 20 日在 ClinicalTrials.gov 注册,NCT04823273。经科罗拉多大学机构审查委员会批准(19-0918),方案版本 1 于 2019 年 4 月 19 日批准,于 2019 年 4 月 30 日批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c70/10165805/6c02d92b4ec8/13063_2023_7319_Fig1_HTML.jpg

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