Factors and Outcomes Associated with Inappropriate Prescribing of Phosphodiesterase-5-Inhibitors for Pulmonary Hypertension

与磷酸二酯酶 5 抑制剂不当治疗肺动脉高压相关的因素和结果

• 批准号: 10296123
• 负责人: Renda Soylemez Wiener
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10296123
• 关键词: Factors; Outcomes; Associated; Inappropriate; Prescribing

 DESCRIPTION (provided by applicant): Both within and outside the VA, inappropriate use of medications is common, affecting approximately 20-25% of Veterans aged 65 years or older. As such, VHA has shown great interest in the American Board of Internal Medicine's Choosing Wisely campaign, which asks medical societies to identify five commonly used tests or treatments in their specialty that provide little benefit to patients, may cause harm, and are costly. One of the Choosing Wisely recommendations advised against inappropriate use of vasodilators such as phosphodiesterase-5-inhibitors (PDE5I) for certain types of pulmonary hypertension (PH). These medications are costly and can be harmful when used inappropriately. In our pilot work we found that over 4000 Veterans were treated with PDE5I for PH from FY 2005-2012, with 100-fold variation in frequency of inappropriate use across sites. In order to reduce inappropriate prescribing, we must first understand the factors driving decision-making surrounding prescribing of PDE5I for PH, as well as the outcomes associated with its use in VA. This work will identify lessons on how to reduce inappropriate prescribing that can be applied to de-implement use of other high cost medications with little benefit and potential for harm. We propose a mixed methods study with the following 3 specific aims: 1: Identify patient-, clinician-, and site-level determinants of inappropriate use of PDE5I for PH 2: Evaluate processes of prescribing and approval of PDE5I for PH in local contexts and identify best practices 3: Assess the outcomes of inappropriate use of PDE5I for PH. The study aims include: Aim 1: Using national VA data and linked Medicare claims, we will build mixed effects regression models to assess factors associated with inappropriate prescribing of PDE5I for PH, comparing patients prescribed PDE5I with similar patients who did not receive PDE5I. Aim 2: Through protocol review and in- depth qualitative interviews with key informants (patients, clinicians, pharmacists, VA leadership), we will conduct qualitative evaluations of patient-provider and inter-professional processes that result in decisions about use of PDE5I for PH at 6 VA sites (3 with high utilization, 3 with low utilization). Aim 3: We will form cohorts of PH patients who did or did not receive PDE5I inappropriately and identify outcomes using national abstracted data. Risks for important outcomes, including mortality, hospitalizations, and adverse effects of PDE5I, will be compared in the two cohorts. We will perform propensity score matching to adjust for potential confounding. Promoting safe and effective prescribing is a primary goal of the VHA, and of our operational partners in the Pharmacy Benefits Management office and the National Program Office for Pulmonary Medicine. This proposal will lay the groundwork to inform a future proposal to develop and implement targeted strategies to reduce inappropriate prescribing of PDE5I for PH. Moreover, this work will serve as a generalizable test case to inform how several factors influence prescribing: 1) tensions between guidelines, VA policies, and individual patient care, 2) how non-VA prescriptions for dual care patients are handled, 3) role of pharmacists in gate-keeping and point-of-care decision-making, 4) local implementation of national policies. This work is firmly in line with the call to de-implement ineffective care outlined in the Blueprint for Excellence (Strategy 2).

 描述（由申请人提供）： 在退伍军人管理局内外，药物使用不当的情况很常见，影响了大约 20-25% 的 65 岁或以上退伍军人。因此，VHA 对美国内科医学委员会的“明智选择”活动表现出了极大的兴趣，该活动要求医学会确定其专业领域内五种常用的测试或治疗方法，这些方法或治疗方法对患者几乎没有好处，可能会造成伤害，而且成本高昂。其中一项“明智选择”建议建议不要不当使用血管扩张剂，例如磷酸二酯酶 5 抑制剂 (PDE5I)，以治疗某些类型的肺动脉高压 (PH)。这些药物价格昂贵，如果使用不当可能会造成伤害。在我们的试点工作中，我们发现从 2005 财年到 2012 财年，超过 4000 名退伍军人接受了 PDE5I 治疗 PH，不同地点不当使用的频率存在 100 倍的差异。为了减少不当处方，我们必须首先了解推动 PDE5I 治疗 PH 处方的决策因素，以及与其在 VA 中使用相关的结果。这项工作将总结如何减少不当处方的经验教训，这些经验教训可用于禁止使用其他几乎没有好处且有潜在危害的高成本药物。我们提出了一项混合方法研究，具有以下 3 个具体目标： 1：识别患者、临床医生、 不恰当使用 PH 的 PDE5I 的场所级决定因素 2：评估当地情况下为 PH 开具 PDE5I 的处方和批准流程，并确定最佳实践 3：评估不恰当使用 PH 的 PDE5I 的结果。该研究的目标包括： 目标 1：利用国家 VA 数据和关联的医疗保险索赔，我们将建立混合效应回归模型，以评估与不恰当的 PH 处方 PDE5I 相关的因素，将处方 PDE5I 的患者与未接受 PDE5I 的类似患者进行比较。目标 2：通过方案审查和对关键信息提供者（患者、临床医生、药剂师、 VA 领导层），我们将对患者-提供者和跨专业流程进行定性评估，从而决定在 6 个 VA 站点（3 个利用率高，3 个利用率低）使用 PDE5I 治疗 PH。目标 3：我们将形成有或没有的 PH 患者队列 不恰当地接收 PDE5I 并使用国家摘要数据确定结果。将比较两个队列中重要结局的风险，包括死亡率、住院治疗和 PDE5I 的不良反应。我们将进行倾向评分匹配以调整潜在的混杂因素。促进安全有效的处方是 VHA 以及我们在药品福利管理办公室和国家肺科项目办公室的运营合作伙伴的首要目标。该提案将为未来的提案奠定基础，以制定和实施有针对性的策略，以减少对 PH 的不当 PDE5I 处方。此外，这项工作将作为一个可概括的测试案例，以告知几个因素如何影响处方：1）指南、VA政策和患者个体护理之间的紧张关系，2）如何处理双重护理患者的非VA处方，3）药剂师在把关和护理点决策中的作用，4）国家政策的本地实施。这项工作完全符合蓝图中概述的消除无效护理的呼吁 卓越（策略 2）。