Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
314 participants
INTERVENTIONAL
2001-02-28
2004-11-30
Brief Summary
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Detailed Description
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Elderly patients from Wishard Health Services with a diagnosis of heart failure (n=314) were randomly assigned to the pharmacist intervention or usual care group. Patients in the intervention group received verbal and written education, icon-based labeling of their medication containers, and therapeutic monitoring. A main objective of the pharmacist was to reinforce primary care providers' instructions to the patient. The pharmacist educated patients about their medications, identified barriers to appropriate drug use, coached patients on overcoming drug use barriers, and coordinated drug use for these patients with primary care providers. Patients in the usual care (control) group did not receive the intervention and also served as a prospective cohort to identify the determinants of acute exacerbation.
To measure medication compliance objectively, electronic monitor lids were used on all heart failure medications for patients in intervention and control groups. These lids contain a computer chip that electronically imprints a time/date stamp when opened and closed. Each open-close event indicates that the patient has taken a dose of their medication. By downloading this information from the medication container lid to a computer, we can objectively assess the pattern of medication compliance. Study participation for the patients in the intervention group concluded after nine months of active intervention and three months of post-intervention follow-up.
The usual care group permitted our identification of the causes for clinical deterioration in patients with heart failure. The unique electronic medical record at our institution, the Regenstrief Medical Record System, permits capture of a wealth of clinical data, which can be merged with primary data from the trial (for example, medication adherence by MEMS caps, brain natriuretic peptide, and quality of life assessments). Patients' data captured from the Regenstrief Medical Record System during the year of follow-up were used to perform multivariate analyses to determine causes of clinical deterioration. So doing provided insights into the pathophysiology of decompensation in patients with heart failure to enhance our understanding of risk factors of this increasingly prevalent disease and thereby lead us to better therapeutic strategies.
Covariates used in our analyses of risk factors included age, sex, race, weight, ejection fraction, brain natriuretic peptide and other renal autacoids, and New York Heart Association classification. Endpoints include health-related quality of life, heart failure exacerbation, patient satisfaction, and healthcare costs. We evaluated the effectiveness of the pharmacy-based program in improving adherence to heart failure medications, improving health-related quality of life, decreasing heart failure exacerbations, increasing patient satisfaction, and decreasing health care costs. Once identified, factors predicting decompensation of heart failure may become the targets of future interventions aimed at preventable causes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Interventions
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Pharmacist intervention
Eligibility Criteria
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Inclusion Criteria
* prescription for at least one cardiovascular medication for heart failure
* plan to receive care and prescriptions at the study health care facility
* ability to hear within the normal range of conversation
* English speaking
* willingness to obtain echocardiography
Exclusion Criteria
50 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Indiana University School of Medicine
OTHER
Purdue University
OTHER
Wishard Health Services
OTHER
University of North Carolina
OTHER
Principal Investigators
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Michael D Murray, PharmD, MPH
Role: PRINCIPAL_INVESTIGATOR
UNC-Chapel Hill
Locations
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UNC Chapel Hill, School of Pharmacy, CB 7360
Chapel Hill, North Carolina, United States
Countries
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References
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Noureldin M, Plake KS, Morrow DG, Tu W, Wu J, Murray MD. Effect of health literacy on drug adherence in patients with heart failure. Pharmacotherapy. 2012 Sep;32(9):819-26. doi: 10.1002/j.1875-9114.2012.01109.x. Epub 2012 Jun 28.
Kim KM, Murray MD, Tu W, Robarge J, Ding Y, Brater DC, Flockhart DA. Pharmacogenetics and healthcare outcomes in patients with chronic heart failure. Eur J Clin Pharmacol. 2012 Nov;68(11):1483-91. doi: 10.1007/s00228-012-1280-z. Epub 2012 Apr 29.
Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch Intern Med. 2009 Apr 27;169(8):757-63. doi: 10.1001/archinternmed.2009.59.
Murray MD, Tu W, Wu J, Morrow D, Smith F, Brater DC. Factors associated with exacerbation of heart failure include treatment adherence and health literacy skills. Clin Pharmacol Ther. 2009 Jun;85(6):651-8. doi: 10.1038/clpt.2009.7. Epub 2009 Mar 4.
Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.
Other Identifiers
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