Improving Drug Use for Elderly Heart Failure Patients

2014-07-23 21:35:08 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Heart Failure


Pharmacist intervention


UNC Chapel Hill, School of Pharmacy, CB 7360
Chapel Hill
North Carolina
United States




University of North Carolina, Chapel Hill

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:35:08-0400

Clinical Trials [2676 Associated Clinical Trials listed on BioPortfolio]

Pharmacist Role in HF Patients Transition of Care

To assess the effectiveness of pharmacist's provided education in HF patients, in improving patients' knowledge and self-efficacy, and to assess the impact of this intervention on the rate...

Community Pharmacy Medication Therapy Management for Heart Failure

Pharmacist-provided medication therapy management (MTM) services have been suggested as a way to improve heart failure (HF) outcomes and counter fragmented care. Nevertheless, broad implem...

Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services

Patients admitted for heart failure that are provided discharge medication services by a pharmacist are less likely to be readmitted within 30 days of primary admission.

Randomized Trial of MTM Pharmacist Intervention in Heart Failure

Out-of-hospital care of complex diseases, such as heart failure, is transitioning from an individual patient-doctor relationship to population health management strategies. As an example, ...

Heart Failure Evaluation Acute Referral Team Trial (HEARTT)

The purpose of this study is to assess the impact of a multidisciplinary team clinic including a clinical pharmacist, a registered nurse (RN), dietician and physician providing short-term ...

PubMed Articles [10155 Associated PubMed Articles listed on BioPortfolio]

A Mobile Application for Patients With Heart Failure: Theory- and Evidence-Based Design and Testing.

Self-care is vital for the successful management of heart failure. Mobile health can enable patients with heart failure to perform effective self-care. This article describes the theory-guided develop...

Common Postoperative Heart Transplant Complications.

Heart failure or congestive heart failure remains a major public health concern on the global scale. End-stage heart failure is a severe disease where the heart is unable to pump enough oxygen and nut...

Effects of pharmacist intervention in Vancomycin treatment for patients with bacteremia due to Methicillin-resistant Staphylococcus aureus.

We conducted a retrospective study based on composite endpoints for treatment failure to evaluate the effect of pharmacist-led VCM initial dose planning for Methicillin-resistant Staphylococcus aureus...

In-hospital and 3-year outcomes of heart failure patients in South India: The Trivandrum Heart Failure Registry.

Long-term data on outcomes of participants hospitalized with heart failure (HF) from low and middle-income countries are limited.

Prospective evaluation of integrated device diagnostics for heart failure management: results of the TRIAGE-HF study.

The primary aim of the TRIAGE-HF trial was to correlate cardiac implantable electronic device-generated heart failure risk status (HFRS) with signs, symptoms, and patient behaviours classically associ...

Medical and Biotech [MESH] Definitions

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.

Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).

More From BioPortfolio on "Improving Drug Use for Elderly Heart Failure Patients"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial