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15 May 2007 | Volume 146 Issue 10 | Pages 714-725
Background: Patients with heart failure who take several prescription medications sometimes have poor adherence to their treatment regimens. Few interventions designed to improve adherence to therapy have been rigorously tested.
Objective: To determine whether a pharmacist intervention improves medication adherence and health outcomes compared with usual care for low-income patients with heart failure.
Design: Randomized, controlled trial conducted from February 2001 to June 2004.
Setting: University-affiliated, inner-city, ambulatory care practice.
Patients: 314 low-income patients 50 years of age or older with heart failure confirmed by their primary care physician.
Intervention: Patients were randomly assigned to intervention (39% [n = 122]) or usual care (61% [n = 192]) groups and were followed for 12 months. A pharmacist provided a 9-month multilevel intervention, with a 3-month poststudy phase. An interdisciplinary team of investigators designed the intervention to support medication management by patients who have low health literacy and limited resources.
Measurements: Primary outcomes were adherence, as measured by using electronic prescription monitors, and exacerbations requiring emergency department care or hospital admission. Secondary outcomes included health-related quality of life, patient satisfaction with pharmacy services, and total direct costs.
Results: During the 9-month intervention period, medication adherence was 67.9% and 78.8% in the usual care and intervention groups, respectively (difference, 10.9 percentage points [95% CI, 5.0 to 16.7 percentage points]). However, these salutary effects dissipated in the 3-month postintervention follow-up period, in which adherence was 66.7% and 70.6%, respectively (difference, 3.9 percentage points [CI, 5.9 to 6.5 percentage points]). Medications were taken on schedule 47.2% of the time in the usual care group and 53.1% of the time in the intervention group (difference, 5.9 percentage points [CI, 0.4 to 11.5 percentage points]), but this effect also dissipated at the end of the intervention (48.9% vs. 48.6%, respectively; difference, 0.3 percentage point [CI, 5.9 to 6.5 percentage points]). Emergency department visits and hospital admissions were 19.4% less (incidence rate ratio, 0.82 [CI, 0.73 to 0.93]) and annual direct health care costs were lower ($2960 [CI, $7603 to $1338]) in the intervention group.
Limitations: Because electronic monitors were used to ascertain adherence, patients were not permitted to use medication container adherence aids. The intervention involved 1 pharmacist and a single study site that served a large, indigent, inner-city population of patients. Because the intervention had several components, intervention effects could not be attributed to a single component.
Conclusions: A pharmacist intervention for outpatients with heart failure can improve adherence to cardiovascular medications and decrease health care use and costs, but the benefit probably requires constant intervention because the effect dissipates when the intervention ceases.
ClinicalTrials.gov registration number: NCT00388622.
Editors' Notes
Context
Contribution
Implication
The Editors
Author and Article Information
From the University of North Carolina School of Pharmacy, Chapel Hill, North Carolina; Wishard Health Services, Indiana University School of Medicine, and Regenstrief Institute, Indianapolis, Indiana; University of Illinois, Champaign-Urbana, Illinois; Hines Veterans Affairs Hospital, Hines, Illinois; and Feinberg School of Medicine and Northwestern University, Chicago, Illinois.
Grant Support: In part by National Institutes of Health grants R01 AG19105 and R01 HL 69399 (Dr. Murray, principal investigator) and AG01799 (Dr. Brater, principal investigator; Dr. Murray, co-principal investigator).
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Michael D. Murray, PharmD, MPH, Center for Pharmaceutical Outcomes and Policy, School of Pharmacy, University of North Carolina at Chapel Hill, CB 7360 Kerr Hall, Chapel Hill, NC 27599-7360.
Current Author Addresses: Dr. Murray: Center for Pharmaceutical Outcomes and Policy, School of Pharmacy, University of North Carolina at Chapel Hill, CB 7360 Kerr Hall, Chapel Hill, NC 27599-7360.
Dr. Young: Wishard Health Services, 1001 West 10th Street, Indianapolis, IN 46202.
Mr. Hoke: Health Services Research and Development Service, Roudebush Veterans Affairs Medical Center, 1050 Wishard Boulevard, Indianapolis, IN 46202.
Dr. Tu and Ms. Wu: Division of Biostatistics, Department of Medicine, Indiana University School of Medicine, Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202.
Drs. Weiner and Clark: Division of General Internal Medicine and Geriatrics, Department of Medicine, Indiana University School of Medicine, Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202.
Dr. Morrow: Institute of Aviation, Human Factors Division, University of Illinois, Willard Airport, One Airport Road, Q5, MC-394, Savoy, IL 61874.
Dr. Stroupe: Midwest Center for Health Services and Policy Research, Cooperative Studies Program Coordinating Center, Hines Veterans Affairs Hospital, PO Box 5000 (151 H), 5th Avenue and Roosevelt Road, Building 1B260, Hines, IL 60141.
Ms. Smith: Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202.
Dr. Gradus-Pizlo: Krannert Institute of Cardiology, Department of Medicine, Indiana University School of Medicine, 1800 North Capitol Avenue, Indianapolis, IN 46202.
Dr. Weinberger: Department of Health Policy and Administration, University of North Carolina at Chapel Hill, 1101-D McGavran-Greenberg Hall, CB# 7411, Chapel Hill, NC 27599.
Dr. Brater: Indiana University School of Medicine, Indiana University-Purdue University Indianapolis, 1120 South Drive, Fesler Hall, Indianapolis, IN 46202.
Author Contributions: Conception and design: M.D. Murray, W. Tu, M. Weiner, D. Morrow, D. Clark, I. Gradus-Pizlo, M. Weinberger, D.C. Brater.
Analysis and interpretation of the data: M.D. Murray, J. Young, W. Tu, M. Weiner, D. Morrow, K.T. Stroupe, J. Wu, F. Smith, I. Gradus-Pizlo, M. Weinberger, D.C. Brater.
Drafting of the article: M.D. Murray, W. Tu, J. Wu, M. Weinberger.
Critical revision of the article for important intellectual content: M.D. Murray, S. Hoke, W. Tu, M. Weiner, D. Morrow, K.T. Stroupe, J. Wu, I. Gradus-Pizlo, M. Weinberger, D.C. Brater.
Final approval of the article: M.D. Murray, M. Weiner, K.T. Stroupe, J. Wu, D. Clark, I. Gradus-Pizlo, M. Weinberger, D.C. Brater.
Provision of study materials or patients: M.D. Murray, S. Hoke, W. Tu.
Statistical expertise: W. Tu, K.T. Stroupe, J. Wu.
Obtaining of funding: M.D. Murray, D.C. Brater.
Administrative, technical, or logistic support: M.D. Murray, S. Hoke, D.C. Brater.
Collection and assembly of data: M.D. Murray, J. Young, S. Hoke, F. Smith. IMPROVING PATIENT CARE
Pharmacist Intervention to Improve Medication Adherence in Heart Failure
A Randomized Trial
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