Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure.
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.
Murray
Michael D
MD
Department of Pharmacy Practice, Purdue University School of Pharmacy, West Lafayette, Indiana, USA. mmurray@regenstrief.org
Young
James M
JM
Morrow
Daniel G
DG
Weiner
Michael
M
Tu
Wanzhu
W
Hoke
Shawn C
SC
Clark
Daniel O
DO
Stroupe
Kevin T
KT
Wu
Jingwei
J
Deer
Melissa M
MM
Bruner-England
Tina E
TE
Sowinski
Kevin M
KM
Smith
Faye E
FE
Oldridge
Neil B
NB
Gradus-Pizlo
Irmina
I
Murray
Laura L
LL
Brater
D Craig
DC
Weinberger
Morris
M
D000368:Aged; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D003142:Communication; D004348:Drug Labeling; D004512:Education, Pharmacy; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance; D010353:Patient Education as Topic; D010593:Pharmaceutical Services; D010595:Pharmacists; D010820:Physicians; D024382:Professional Role
D002317:Cardiovascular Agents