Center for Education and Research on Therapeutics

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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.