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Improving Drug Use for Elderly Heart Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388622
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : October 17, 2006
National Institutes of Health (NIH)
Indiana University School of Medicine
Purdue University
Wishard Health Services
Information provided by:
University of North Carolina, Chapel Hill

Brief Summary:
The aims of this randomized, clinical trial are to develop and test a multileveled pharmacy-based program to improve the care of patients with heart failure. Risk factors for deterioration of heart failure will be determined including poor adherence to medication.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Pharmacist intervention Not Applicable

Detailed Description:

Medications improve the function and health-related quality of life of patients with heart failure and reduce morbidity, mortality, and the costs of patient care. Due to their complicated medication regimens, however, older adults with heart failure require assistance with their medications to facilitate adherence and improve their health outcomes. Recent studies suggest that the outcomes of patients with heart failure improve when pharmacists provide patients with education and monitoring. This study aims to develop and test, as a randomized controlled trial, a multileveled pharmacy-based program that incorporates patient education materials and medication packaging that target patients with low health literacy.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Drug Use for Elderly Heart Failure Patients
Study Start Date : February 2001
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Medication adherence
  2. Exacerbation of heart failure
  3. Health-related quality of life

Secondary Outcome Measures :
  1. Patient satisfaction
  2. Health care utilization
  3. Direct costs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 50 and older
  • 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:

  • dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388622

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United States, North Carolina
UNC Chapel Hill, School of Pharmacy, CB 7360
Chapel Hill, North Carolina, United States, 27599-7360
Sponsors and Collaborators
University of North Carolina
National Institutes of Health (NIH)
Indiana University School of Medicine
Purdue University
Wishard Health Services
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Principal Investigator: Michael D Murray, PharmD, MPH UNC-Chapel Hill
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00388622    
Other Study ID Numbers: R01AG019105 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: October 2006
Keywords provided by University of North Carolina, Chapel Hill:
Heart failure
Health-related quality of life
Clinical exacerbation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases