Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program

背景：质子泵抑制剂(PPI)是最常见的处方药物之一 VHA，占每年1100多万张30天处方和近5000万美元的药物成本。 尽管PPI对胃食道反流病等酸相关疾病有效，但它有 在观察性研究中与许多潜在危害有关(例如，痴呆症、慢性肾脏 疾病、骨折)，以及退伍军人死亡率增加。尽管如此，PPI仍在继续使用，而不是 适当的适应症或超过必要的更长和更高的剂量。相应地，VHA药房福利 管理服务(PBM)将部署RaPPID-一个全国性的随机PPI去处方计划-在 2018财年的目标客户是那些接受短期PPI可能就足够的患者。这一计划将 包括激活临床药房专家、提供者教育和学术详细说明以及患者 教育。与PBM合作，我们建议对这一国家方案进行分组评估-- 随机设计。 目标：(1)确定系统、提供者和患者层面的障碍和促进者，以取消PPI处方 (形成性评估)；(2)评估停药计划对重要临床结果的影响；以及 了解如何以及为什么实现或未实现这些结果(结果和过程 评估)；(3)评估非处方方案的经济效果(经济评估)。 方法：使用形成性评估方法，我们将首先确定障碍和促进者 RaPPID，在全国随机和部署之前。然后，我们将评估RaPPID对PPI的影响 在集群随机设计中使用(主要结果)(集群=医疗保健系统)。我们还将评估一项 各种意想不到的影响，包括减少PPI使用对上消化道症状和并发症的影响 比如上消化道出血。此外，我们将使用过程评估方法来了解原因和 该计划在特定情况下是有效还是无效的。最后，我们将使用结果中的数据 评价这项提议，以估计拉帕德方案的预算影响，同时考虑到 关于VHA和非VHA医疗保健利用的计划。 影响：RaPPID将是VHA有史以来在取消处方方面最大的协同努力之一。 因此，对该计划的前瞻性评估提供了一个独特的机会，不仅可以提高 计划本身，也是为了深入了解如何在更广泛的范围内减少使用低价值服务，这是一个关键 VHA是未来十年的优先事项。重要的是，我们提出的前瞻性对照研究设计也将 请允许我们就PPI是否会造成它们可能产生的不利影响做出强有力的声明 是有关联的。归根结底，这项评估不仅将提供对 国家努力适当取消对PPI的规定，但也提供了关于如何有效开展 其他此类干预措施，以期在未来解除根深蒂固的临床做法。

Background: Proton pump inhibitors (PPIs) are among the most commonly prescribed medications in the VHA, accounting for over 11 million 30-day prescriptions and nearly $50 million in medication costs annually. Though effective for treatment of acid-related disorders such as gastroesophageal reflux disease, PPIs have been associated with a number of potential harms in observational studies (e.g., dementia, chronic kidney disease, fractures), and increased mortality in Veterans. Nonetheless, PPIs continue to be used without an appropriate indication or for longer and at higher doses than necessary. Accordingly, VHA Pharmacy Benefits Management Services (PBM) will deploy RaPPID – a national Randomized PPI De-prescribing program – in Fiscal Year 2018 targeting patients for whom a short course of PPI is likely sufficient. This program will comprise activation of Clinical Pharmacy Specialists, provider education and academic detailing, and patient education. In partnership with PBM, we propose to conduct an evaluation of this national program in a cluster- randomized design. Objectives: (1) identify system-, provider-, and patient-level barriers and facilitators to PPI de-prescribing (formative evaluation); (2) assess the impact of the de-prescribing program on important clinical outcomes, and to understand how and why these outcomes were achieved or not achieved (outcomes and process evaluation); (3) assess the economic effects of the de-prescribing program (economic evaluation). Methods: Using formative evaluation approaches, we will first identify barriers and facilitators to uptake of RaPPID, prior to national randomization and deployment. We will then assess the impact of RaPPID on PPI use (primary outcome) in a cluster randomized design (cluster = healthcare system). We will also assess a variety of unintended effects, including impact of reduced PPI use on upper GI symptoms and complications such as upper GI bleeding. Furthermore, we will use process evaluation approaches to understand why and how the program was effective or ineffective in specific contexts. Finally, we will use data from the outcomes evaluation of this proposal to estimate the budget impact of RaPPID, taking into account the impact of the program on VHA and non-VHA healthcare utilization. Impact: RaPPID will be among the largest concerted efforts at de-prescribing ever undertaken in VHA. Prospective evaluation of the program therefore presents a unique opportunity not only to enhance the program itself, but also to gain insights about how to reduce the use of low-value services more broadly, a key VHA priority for the coming decade. Importantly, the prospective, controlled study design we propose will also allow us to make strong claims about whether PPIs cause the putative adverse effects to which they have been linked. Ultimately, this evaluation will provide not only valuable insight into the benefits and harms of a national effort to appropriately de-prescribe PPIs, but also broader lessons about how to effectively undertake other such interventions to de-implement entrenched clinical practices in the future.