Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol.
Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol.
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DOI：
10.1186/s13012-020-01078-9
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发表时间：
2021-01-07
期刊：
影响因子：
--
通讯作者：
Choudhry NK
中科院分区：
文献类型：
--
作者：
Lauffenburger JC;Isaac T;Trippa L;Keller P;Robertson T;Glynn RJ;Sequist TD;Kim DH;Fontanet CP;Castonguay EWB;Haff N;Barlev RA;Mahesri M;Gopalakrishnan C;Choudhry NK
给老年人开高风险药物的做法仍然非常普遍，并可能导致可避免的健康后果。减少处方的努力成效有限，部分原因是它们的时机不佳、设计不当或没有提供可操作的信息。基于电子健康记录(EHR)的工具是常用的，但在促进老年人取消处方方面的应用有限。目的是确定使用行为科学原理设计EHR工具是否可以减少老年人不适当的处方和临床结果。新的使用设计来指导提供者在电子健康记录中的参与(NUGH-EHR)项目使用了一项两阶段、16臂的自适应随机实用试验，采用“挑选赢家”的设计，以确定在初级保健提供者及其患者中长期使用苯二氮卓类、镇静催眠药(“Z-药物”)或大型综合交付系统中的抗胆碱类药物的许多潜在电子健康记录工具中最有效的工具。在第一阶段，我们将提供者和他们的患者随机分为普通护理组(n=81名提供者)或15个EHR工具中的一个(n=8个提供者/臂)，这些工具使用包括显著程度、选择架构或默认等行为原则设计。在6个月的 随访后，我们将根据它们对试验的主要结果(两个阶段)的影响对药物进行排序：减少不适当的处方(通过停止或逐渐减少)。在阶段2，我们将随机选择(A)阶段1的普通护理提供者与最有希望的5个阶段1干预中的一个或继续常规护理，以及(B)未选择的分支中的阶段1的提供者以1：1的比例与5个最有希望的干预或常规护理中的一个或一个的比例。二级和三级结果包括开出和使用的药物的数量以及临床上显著的不良结果。第一阶段于2020年10月启动。我们计划在2021年12月完成第二阶段的后续工作。这些结果将促进对行为科学如何优化电子病历决策支持以改善处方和健康结果的理解。适应性试验很少被用于实施科学，因此这些发现也为如何更有效地进行这一领域的试验提供了洞察。临床试验.gov(NCT04284553，注册：2020年2月26日)在线版本包含补充材料，可在10.1186/s13012-020-020-9获得。
The prescribing of high-risk medications to older adults remains extremely common and results in potentially avoidable health consequences. Efforts to reduce prescribing have had limited success, in part because they have been sub-optimally timed, poorly designed, or not provided actionable information. Electronic health record (EHR)-based tools are commonly used but have had limited application in facilitating deprescribing in older adults. The objective is to determine whether designing EHR tools using behavioral science principles reduces inappropriate prescribing and clinical outcomes in older adults. The Novel Uses of Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) project uses a two-stage, 16-arm adaptive randomized pragmatic trial with a “pick-the-winner” design to identify the most effective of many potential EHR tools among primary care providers and their patients ≥ 65 years chronically using benzodiazepines, sedative hypnotic (“Z-drugs”), or anticholinergics in a large integrated delivery system. In stage 1, we randomized providers and their patients to usual care (n = 81 providers) or one of 15 EHR tools (n = 8 providers per arm) designed using behavioral principles including salience, choice architecture, or defaulting. After 6 months of follow-up, we will rank order the arms based upon their impact on the trial’s primary outcome (for both stages): reduction in inappropriate prescribing (via discontinuation or tapering). In stage 2, we will randomize (a) stage 1 usual care providers in a 1:1 ratio to one of the up to 5 most promising stage 1 interventions or continue usual care and (b) stage 1 providers in the unselected arms in a 1:1 ratio to one of the 5 most promising interventions or usual care. Secondary and tertiary outcomes include quantities of medication prescribed and utilized and clinically significant adverse outcomes. Stage 1 launched in October 2020. We plan to complete stage 2 follow-up in December 2021. These results will advance understanding about how behavioral science can optimize EHR decision support to improve prescribing and health outcomes. Adaptive trials have rarely been used in implementation science, so these findings also provide insight into how trials in this field could be more efficiently conducted. Clinicaltrials.gov (NCT04284553, registered: February 26, 2020) The online version contains supplementary material available at 10.1186/s13012-020-01078-9.
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影响因子：
2.8
作者：
Kuhn-Thiel, Alexandra M.;Weiss, Christel;Wehling, Martin
通讯作者：
Wehling, Martin
影响因子：
2.9
作者：
Cooper JA;Cadogan CA;Patterson SM;Kerse N;Bradley MC;Ryan C;Hughes CM
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影响因子：
4.8
作者：
Keller, Punam Anand;Harlam, Bari;Volpp, Kevin G.
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Volpp, Kevin G.
DOI：
10.1197/jamia.m2981
发表时间：
2009-07-01
影响因子：
6.4
作者：
Field, Terry S.;Rochon, Paula;Gurwitz, Jerry H.
通讯作者：
Gurwitz, Jerry H.
影响因子：
39.2
作者：
Emanuel, Ezekiel J.;Ubel, Peter A.;Volpp, Kevin G.
通讯作者：
Volpp, Kevin G.