Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure

Michael D. Murray, James M. Young, Daniel G. Morrow, Michael Weiner, Wanzhu Tu, Shawn C. Hoke, Daniel O. Clark, Kevin T. Stroupe, Jingwei Wu, Melissa M. Deer, Tina E. Bruner-England, Kevin M. Sowinski, Faye E. Smith, Neil B. Oldridge, Irmina Gradus-Pizlo, Laura L. Murray, D. Craig Brater, Morris Weinberger

Research output: Contribution to journalArticle

39 Scopus citations

Abstract

Background: Medications can improve the functioning and health-related quality of life of patients with chronic heart failure (CHF) and reduce morbidity, mortality, and costs of treatment. However, patients may not adhere to therapy. Patients with complex medication regimens and low health literacy are at risk for nonadherence. Objective: The primary goal of this project is to develop and assess a multilevel pharmacy-based program to improve patient medication adherence and health outcomes for elderly CHF patients with low health literacy. Methods: In this 4-year, controlled trial, patients aged ≥50 years with a diagnosis of CHF who are being treated at Wishard Health Services (Indianapolis, Indiana) are randomly assigned to pharmacist intervention or usual care. Intervention patients receive 9 months of pharmacist support and 3 months of postintervention follow-up. The intervention involves a pharmacist providing verbal and written education, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist identifies patients' barriers to appropriate drug use, coaches them on overcoming these barriers, and coordinates medication use issues with their primary care providers. Daily updates of relevant monitoring data are delivered via an electronic medical record system and stored in a personal computer system designed to support pharmacist monitoring and facilitate documentation of interventions. To measure medication adherence objectively, electronic monitoring lids are used on all CHF medications for patients in both study groups. Other assessments include self-reported medication adherence, results of echocardiography (eg, ejection fraction), brain natriuretic peptide concentrations, and health-related quality of life. Health services utilization, refill adherence, and cost data derive from electronic medical records. After completion of this study, the data can be used to assess the effectiveness and cost-effectiveness of our intervention. Results: One hundred twenty-two patients have been assigned to receive the intervention and 192 to receive usual care. Conclusions: Our study aims to improve patients' knowledge and self-management of their medication and to improve medication monitoring in a multilevel pharmacy-based intervention. By doing so, we intend that the intervention will improve the health outcomes of elderly patients with CHF.

Original languageEnglish (US)
Pages (from-to)53-65
Number of pages13
JournalAmerican Journal Geriatric Pharmacotherapy
Volume2
Issue number1
DOIs
StatePublished - Mar 2004

Keywords

  • Heart failure
  • Medication adherence
  • Outcomes research

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Geriatrics and Gerontology

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    Murray, M. D., Young, J. M., Morrow, D. G., Weiner, M., Tu, W., Hoke, S. C., Clark, D. O., Stroupe, K. T., Wu, J., Deer, M. M., Bruner-England, T. E., Sowinski, K. M., Smith, F. E., Oldridge, N. B., Gradus-Pizlo, I., Murray, L. L., Brater, D. C., & Weinberger, M. (2004). Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure. American Journal Geriatric Pharmacotherapy, 2(1), 53-65. https://doi.org/10.1016/S1543-5946(04)90007-4