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

背景：质子泵抑制剂（PPI）是最常见的处方药之一， VHA，占超过1100万30天的处方和近5000万美元的药物费用每年。 尽管PPI对酸相关疾病如胃食管反流病的治疗有效， 在观察性研究中与许多潜在危害相关（例如，慢性肾性痴呆 疾病，骨折），并增加退伍军人的死亡率。尽管如此，PPI仍在使用， 适当的适应症或更长的时间和更高的剂量比必要的。因此，VHA药房福利 管理服务（PBM）将部署RaPPID -国家随机PPI取消处方计划-在 2018财年针对短期PPI可能足够的患者。此程序将 包括激活临床药学专家，提供者教育和学术细节，以及患者 教育我们建议与PBM合作，对这一国家方案进行一次集群评估- 随机设计 目的：（1）识别系统、提供者和患者层面的PPI取消处方障碍和促进因素 （形成性评价）;（2）评估取消处方计划对重要临床结局的影响，以及 了解这些结果是如何实现的以及为什么没有实现（结果和过程 （3）评估取消处方计划的经济效果（经济评估）。 方法：使用形成性评价方法，我们将首先确定吸收的障碍和促进因素， RaPPID，在国家随机化和部署之前。然后，我们将评估RaPPID对PPI的影响 使用（主要结局）采用分组随机设计（分组=医疗保健系统）。我们还将评估 各种非预期效应，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理解为什么， 在特定环境下，该计划是有效的还是无效的。最后，我们将使用来自结果的数据， 评估这一建议，以估计区域伙伴关系促进发展方案的预算影响，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有史以来最大的取消处方的协同努力之一。 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，但也获得有关如何更广泛地减少低价值服务的使用的见解，一个关键 未来十年的VHA优先事项。重要的是，我们提出的前瞻性对照研究设计也将 允许我们对PPI是否会引起它们所具有的假定不良反应做出强有力的声明， 被链接。最终，这项评估不仅将提供有价值的洞察力的好处和危害， 国家努力适当地取消处方PPI，但也有更广泛的经验教训，如何有效地开展 其他此类干预措施，以在未来取消根深蒂固的临床实践。

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.