Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD)

描述(由申请人提供)：出院后严重的用药差错是常见的，并会导致患者严重的发病率。错误在服用心血管药物的患者中更常见，在健康素养较低的患者中也可能更常见。另一方面，健康素养低的患者可能比其他患者从旨在提高知识和技能的干预措施中受益更多。这项研究的目的是减少急性冠脉综合征(ACS)或心力衰竭(HF)恶化住院患者出院后前30天内严重用药错误的发生率。我们将在两个学术医疗中心：埃默里大学/格雷迪纪念医院(GMH)和布里格姆妇女医院(BWH)，对862名从普通医学服务出院的患者进行基于药剂师的识字敏感干预的随机对照试验。这项研究将包括两个方面：1)日常护理：药剂师只对用药顺序进行常规评估，医生进行药物调节，护士在出院时提供药物咨询；以及2)干预：药剂师协助进行药物调节，出院时对患者进行药剂师咨询，提供对识字敏感的患者教育工具，详细说明出院药物，以及1-2天后以及随后需要时的后续电话。随机化将在患者层面上进行。主要结果将是出院后30天内至少出现一次严重用药错误的患者的百分比。严重的用药差错包括：1)本来可以预防的实际不良药物事件(ADE)(可预防的ADE)，2)本可以减少严重程度或持续时间的实际ADE(可改善的ADE)，以及3)可能导致不良事件(潜在ADE)的用药不符或不遵守。严重用药错误的裁决将由两名盲目研究任务的独立医生执行。将根据健康素养水平进行分组分析，以确定健康素养不足的患者是否更有可能从干预中受益。还将评估项目成本。如果成功，这种干预可以提供一个重要的手段，减少住院后的用药差错。

DESCRIPTION (provided by applicant): Serious medication errors are common after hospital discharge and cause significant patient morbidity. Errors are more common among patients taking cardiovascular medications and may also be more common among patients with low health literacy. On the other hand, patients with low health literacy may benefit more than other patients from interventions designed to improve knowledge and skills. The objective of this research is to reduce the incidence of serious medication errors during the first 30 days after hospital discharge among patients hospitalized with acute coronary syndromes (ACS) or heart failure (HF) exacerbation. We will conduct a randomized controlled trial of a literacy-sensitive, pharmacist-based intervention in 862 patients discharged from the general medicine service at two academic medical centers: Emory University/Grady Memorial Hospital (GMH) and Brigham and Women's Hospital (BWH). The study will have two arms: 1) Usual Care: pharmacists performing only routine evaluations of medication orders, physicians performing medication reconciliation, and nurses providing medication counseling at discharge; and 2) Intervention: pharmacist assistance with medication reconciliation, pharmacist counseling of patients at the time of discharge, provision of a literacy-sensitive patient education tool detailing the discharge medications, and a follow-up phone call 1-2 days later and subsequently if needed. Randomization will occur at the level of the patient. The primary outcome will be the percent of patients with at least one serious medication error within 30 days after hospital discharge. Serious medication errors consist of: 1) actual adverse drug events (ADEs) that could have been prevented (preventable ADEs), 2) actual ADEs that could have been reduced in severity or duration (ameliorable ADEs), and 3) medication discrepancies or non- adherence with the potential to cause adverse events (potential ADEs). Adjudication of serious medication errors will be performed by two independent physicians blinded to study assignment. Subgroup analyses will be performed by level of health literacy to determine if patients with inadequate health literacy are more likely to benefit from the intervention. Program costs will also be assessed. If successful, this intervention could offer an important means of reducing medication errors in the post-hospitalization period.