Center for Education and Research on Therapeutics

描述（由申请人提供）： 项目摘要：使用索赔数据库对特定疾病进行药物比较有效性研究的障碍是缺乏临床信息，包括疾病严重程度的测量。为了开发一种方法来获得这些数据的比较有效性研究，我们提出了一个试点方法学研究，以评估使用社区药剂师进行和记录的结果评估的患者在社区为基础的设置。该项目将提供深入了解药剂师是否可以有效地进行比较有效性研究。本研究将使用心力衰竭作为模型。心力衰竭通常是缺血性心脏病和/或不受控制的高血压的结果。 目的：我们建议进行一项试点方法研究，以评估社区药剂师在社区环境中对患者进行监测和结果评估。 设计：我们建议进行一项描述性、前瞻性、单组、住院后一个月的初步方法学研究。 参与者：患者样本将是因心力衰竭加重住院后出院的患者。药剂师样本将包括为入组本研究的心力衰竭患者提供门诊社区药房服务的社区药剂师。 干预措施：社区药剂师将在住院治疗心力衰竭后一周内对患者参与者进行半结构化电话评估，并在出院后约30天再次进行评估。将使用明尼苏达心力衰竭生活问卷（MLHFQ）评估治疗有效性。还将评估药物不良事件。 结果：将报告患者、社区药房和药剂师的参与率。本研究将确定出院药物医嘱与社区药房药物配置之间的一致程度。此外，将描述MLHFQ的平均评分和可靠性指标。药剂师收集的不良事件数据的完整性将与FDA Medwatch自愿报告系统报告的数据进行比较。最后，将评价患者和药剂师对研究过程的满意度。 相关性：本研究将评估使用社区药剂师直接从患者收集临床信息的可行性，以进行比较有效性和安全性研究。

DESCRIPTION (PROVIDED BY APPLICANT): Project Summary: A barrier to conducting comparative effectiveness research of medications within a particular disease using claims databases is the lack of clinical information, including measures of disease severity. In order to develop a method to obtain these data for comparative effectiveness research, we propose a pilot methodological study to evaluate the use of community pharmacist to conduct and document outcomes evaluations of patients in a community-based setting. This project will provide insight into whether pharmacists can effectively perform comparative effectiveness research. This study will use heart failure as a model. Heart failure is frequently a result of ischemic heart disease and/or uncontrolled hypertension. Objective: We propose to conduct a pilot methodological study to evaluate community pharmacists to monitor and conduct outcomes evaluations of patients in a community-based setting. Design: We propose to perform a descriptive, prospective, single-group, one-month post hospitalization, pilot methodological study. Participants: The patient sample will be persons being discharged after a hospitalization due to exacerbation of heart failure. The pharmacist sample will consist of community pharmacists that provide outpatient community pharmacy services to the patients with heart failure that are enrolled in this study. Intervention: Community pharmacists will conduct a semi-structured telephone assessment of the patient participant within one week following hospitalization for the treatment of heart failure and again at approximately 30 days following discharge. Therapeutic effectiveness will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Medication adverse events also will be assessed. Outcomes: Participation rates for patients, community pharmacies, and pharmacists will be reported. The study will determine the degree of agreement between hospital discharge medication orders and community pharmacy medication profiles. In addition, mean scores and reliability measures for the MLHFQ will be described. The completeness of data collected on adverse events captured by the pharmacists will be compared to data reported to the FDA's Medwatch voluntary reporting system. Finally, patient and pharmacist satisfaction with the study process will be evaluated. Relevance: This study will assess the feasibility of using community pharmacists to collect clinical information directly from patients for the purpose of conducting comparative effectiveness and safety research.