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

描述（由申请人提供）：严重的用药错误是出院后常见的，并导致严重的患者发病率。错误在服用心血管药物的患者中更为常见，在健康素养较低的患者中也可能更为常见。另一方面，卫生知识普及程度低的患者可能比其他患者更能从旨在提高知识和技能的干预措施中获益。本研究的目的是减少急性冠状动脉综合征（ACS）或心力衰竭（HF）加重住院患者出院后30天内严重用药错误的发生率。我们将对两个学术医疗中心（Emory University/Grady Memorial Hospital （GMH）和Brigham and Women's Hospital (BWH)）的862名从普通医学部门出院的患者进行一项对读写能力敏感的、基于药剂师的干预的随机对照试验。该研究将分为两部分：1)常规护理：药剂师仅对药物订单进行常规评估，医生进行药物调解，护士在出院时提供药物咨询；2)干预措施：药剂师协助进行药物调解，在出院时为患者提供药剂师咨询，提供识字敏感的患者教育工具，详细说明出院药物，1-2天后随访电话，如果需要，后续电话。随机化将在患者水平上进行。主要结果将是出院后30天内至少有一次严重用药错误的患者的百分比。严重的药物错误包括：1)本可预防的实际药物不良事件（ADEs）（可预防的ADEs）， 2)严重程度或持续时间本可减少的实际ade（可改善的ADEs），以及3)可能导致不良事件的药物差异或不依从性（潜在的ADEs）。严重用药错误的判定将由两名独立的医生进行，对研究任务不知情。将按健康素养水平进行亚组分析，以确定健康素养不足的患者是否更有可能从干预中受益。项目成本也将被评估。如果成功，这种干预可以提供减少住院后用药错误的重要手段。

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.