Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)
Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)
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DOI：
10.1186/s13012-018-0795-9
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发表时间：
2018-08-06
影响因子：
7.2
通讯作者：
Bradley, Katharine A.
中科院分区：
文献类型：
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作者：
Glass, Joseph E.;Bobb, Jennifer F.;Bradley, Katharine A.
背景资料：专家建议将酒精相关护理纳入初级保健（PC），以改善对不健康酒精使用的预防和治疗。然而，很少有医疗保健系统提供这样的综合护理。为了解决这一差距，Kaiser Permanente华盛顿（KPWA）的实施研究人员和临床领导者合作设计了一个高质量的循证护理计划，用于不健康的酒精用途：持续的以患者为中心的酒精相关护理计划。卫生部实施临床护理系统，旨在加强对不健康酒精使用的预防和治疗。这种对不健康酒精使用的临床护理使用三种策略来实施：电子健康记录（EHR）决策支持，性能监测和反馈，以及来自具有酒精相关护理专业知识的外部实践教练的一线支持（下文称为“实施干预”）。这份报告的目的是描述的协议，酒精测试，务实，集群随机，步进楔形实施试验，以评估是否酒精测试实施干预增加酒精筛查和简短的酒精咨询（所谓的简短干预），以及22个KPWA PC诊所中酒精使用障碍（AUD）的诊断和治疗。方法/设计：试验样本包括在研究期间（2015年1月1日至2018年7月31日）访问试验中22个初级保健中心中任何一个的所有成年患者。22个研究中心被随机分配，在不同日期（分7波，大约每4个月一次）实施Risk计划。主要结局是PC访视的患者比例，这些患者（1）筛查不健康酒精使用呈阳性，并记录了简短的干预措施，（2）有新认识的AUD，随后开始并参与酒精相关护理。主要分析比较了这些主要结局在实施前和实施后的发生率，遵循推荐的分析阶梯楔形试验的方法。定性分析评估执行的障碍和促进因素以及执行战略所需的调整。据我们所知，EHR试验是第一项使用实验设计来测试具有酒精相关护理专业知识的实践教练，沿着EHR临床决策支持和性能监控以及对站点的反馈，增加预防性护理-酒精筛查和短暂干预-以及AUD的诊断和治疗。
Background: Experts recommend that alcohol-related care be integrated into primary care (PC) to improve prevention and treatment of unhealthy alcohol use. However, few healthcare systems offer such integrated care. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington (KPWA) partnered to design a high-quality program of evidence-based care for unhealthy alcohol use: the Sustained Patient-centered Alcohol-related Care (SPARC) program. SPARC implements systems of clinical care designed to increase both prevention and treatment of unhealthy alcohol use. This clinical care for unhealthy alcohol use was implemented using three strategies: electronic health record (EHR) decision support, performance monitoring and feedback, and front-line support from external practice coaches with expertise in alcohol-related care ("SPARC implementation intervention" hereafter). The purpose of this report is to describe the protocol of the SPARC trial, a pragmatic, cluster-randomized, stepped-wedge implementation trial to evaluate whether the SPARC implementation intervention increased alcohol screening and brief alcohol counseling (so-called brief interventions), and diagnosis and treatment of alcohol use disorders (AUDs) in 22 KPWA PC clinics.Methods/Design: The SPARC trial sample includes all adult patients who had a visit to any of the 22 primary care sites in the trial during the study period (January 1, 2015-July 31, 2018). The 22 sites were randomized to implement the SPARC program on different dates (in seven waves, approximately every 4 months). Primary outcomes are the proportion of patients with PC visits who (1) screen positive for unhealthy alcohol use and have documented brief interventions and (2) have a newly recognized AUD and subsequently initiate and engage in alcohol-related care. Main analyses compare the rates of these primary outcomes in the pre- and post-implementation periods, following recommended approaches for analyzing stepped-wedge trials. Qualitative analyses assess barriers and facilitators to implementation and required adaptations of implementation strategies.Discussion: The SPARC trial is the first study to our knowledge to use an experimental design to test whether practice coaches with expertise in alcohol-related care, along with EHR clinical decision support and performance monitoring and feedback to sites, increase both preventive care-alcohol screening and brief intervention-as well as diagnosis and treatment of AUDs.