Improving Safety after Hospitalization in Older Persons on High Risk Medications

 说明(由申请者提供)：《国家预防不良药物事件行动计划》确定了三个高度优先的药物类别，作为降低药物相关伤害风险的关键目标：抗凝剂；糖尿病药物(胰岛素和口服药物)；以及阿片类药物。之所以选择这些药物类别，是因为它们对患者造成的可测量的药物相关伤害的数量最多，而且与这些药物相关的相当大比例的ADE被认为是可以预防的。拟议项目的总体目标是进行一项大型临床试验，重点是最近出院的老年患者，他们已经开了抗凝剂、糖尿病药物或阿片类药物。这项临床试验将确定多方面用药错误和ADE减少干预的价值，并特别关注家庭评估。干预措施将包括：(1)临床药剂师对高风险患者进行家庭评估；(2)针对高风险患者及其照顾者的最佳实践、循证用药安全工具和资源；(3)通过电子健康记录与初级保健团队沟通，了解与使用高风险药物有关的问题以及其他用药安全问题；(4)药剂师在家访后14天内给患者和/或照顾者打电话进行跟踪。令人感兴趣的主要结果将是临床上重要的用药错误，即由可预防或可改善的不良反应和由于药物差异或不坚持而可能发生的不良反应组成的综合结果。次要结果将包括：(1)可预防或可改善的不良反应；(2)由于不一致或不遵守而导致的潜在不良反应；以及(3)可预防或可改善的被判定为严重、危及生命或致命的不良反应。从这次试验中获得的知识是实质性的。正如PA-14-002(通过安全用药研究促进患者安全实施)中所述，“减少不良药物事件(ADE)是卫生与公众服务部(DHHS)的首要任务，目前正在制定一项全面的战略，以显著减少三类ADE中的ADE：抗凝剂、糖尿病药物和阿片类药物。”这项研究建议符合DHHS的优先事项，并与AHRQ的患者安全组合保持一致，该组合致力于开发、实施和采用工具和资源，以改善健康结果。拟议研究的最终目标是通过展示一种有效的干预策略来降低这种风险，从而减轻高危老年患者(AHRQ优先人群)与不良反应相关的公共健康负担。

 DESCRIPTION (provided by applicant): The National Action Plan for Adverse Drug Event (ADE) Prevention identified three high-priority drug classes as key targets for reducing the risk of drug-related injuries: anticoagulants; diabetes agents (insulin and oral agents); and opioids. These medication classes were chosen because they account for the greatest number of measurable drug-related harms to patients, and a substantial proportion of ADEs associated with these medications is considered preventable. The overarching objective of the proposed project is to pursue a large clinical trial focused on older patients recently discharged from the hospital who have been prescribed anticoagulants, diabetes agents, or opioids. The clinical trial will determine the value of a multifaceted medication error and ADE reduction intervention with a special focus on in-home assessment. Components of the intervention will include: (1) in-home assessment of high-risk patients by a clinical pharmacist; (2) best- practice, evidence-based medication safety tools and resources targeted to high-risk patients and their caregivers; (3) communication with the primary care team via the electronic health record regarding concerns relevant to the use of high-risk medications as well as other medication safety concerns; and (4) a follow-up phone call by the pharmacist to the patient and/or caregiver within 14 days of the home visit. The primary outcome of interest will be clinically important medication errors, a composite outcome comprised of preventable or ameliorable ADEs and potential ADEs due to medication discrepancies or non-adherence. Secondary outcomes will include: (1) preventable or ameliorable ADEs; (2) potential ADEs due to discrepancies or non-adherence; and (3) preventable or ameliorable ADEs judged to be serious, life- threatening, or fatal. The knowledge to be gained from this trial is substantial. As stated in PA-14-002 (Advancing Patient Safety Implementation through Safe Medication Use Research), "Reduction of adverse drug events (ADEs) is a top priority for the Department of Health and Human Services (DHHS), and a comprehensive strategy is in development in order to significantly reduce ADEs within the three classes which account for a significant proportion of all ADEs: anticoagulants, diabetes agents, and opioids." This research proposal aligns with this DHHS priority and with the Patient Safety Portfolio at AHRQ which is committed to the development, implementation and adoption, and wide-spread dissemination of tools and resources to improve health outcomes. The ultimate goal of the proposed research is to mitigate the public health burden related to ADEs among high-risk elderly patients (an AHRQ priority population) by demonstrating an effective intervention strategy to reduce this risk.