Pharmacist Intervention to Improve Medication Adherence in Heart Failure

Context Patients sometimes have difficulty following complicated treatment regimens. Contribution In this trial, 314 low-income patients with congestive heart failure were randomly assigned to a pharmacist intervention or usual care. The pharmacist assessed patient knowledge and provided instructions about medication use. During the 9-month intervention, patients in the intervention group had greater medication adherence than patients in the usual care group (79% vs. 68%). These differences dissipated within 3 months of stopping the intervention. Patients in the intervention group also had fewer exacerbations resulting in emergency department visits or hospitalizations than patients in the usual care group. Implication Ongoing educational intervention by a pharmacist can improve medication adherence and outcomes in patients with heart failure. The Editors In the United States, 5 million people have heart failure, with total health care costs exceeding $29 billion (1). These costs are largely derived from expensive exacerbations that require emergency visits and hospitalizations (1, 2). Regularly administered cardiovascular medications may preserve cardiac function, improve quality of life, and reduce risk for costly exacerbations. However, patients sometimes do not adhere to prescribed instructions and have poor outcomes (35). Researchers have estimated that approximately 50% of patients with chronic illnesses do not take their medications as prescribed (6). Reasons for nonadherence include lack of patient knowledge, skills, and support to appropriately self-manage complicated medication regimens (7, 8). Although chronic disease management programs abound, few studies have rigorously tested interventions aimed at improving patient adherence to prescribed medications and their effect on health outcomes (9, 10). We conducted a randomized clinical trial to assess the effect of a pharmacist intervention on patients who are socioeconomically disadvantaged and medically vulnerable. We hypothesized that the intervention would improve adherence to heart failure medications, reduce exacerbations requiring emergency department visits or hospitalization, improve disease-specific quality of life, increase patient satisfaction, and reduce health care costs. Methods Design Overview The methods for our randomized trial are described elsewhere (1113). We recruited patients from the general medicine and cardiology practices of Wishard Health Services, Indianapolis, Indiana, which serves socioeconomically disadvantaged and medically vulnerable patients. The study was conducted from February 2001 to June 2004. Patients took part in the study for 12 months and received 9 months of active intervention by the pharmacist or usual care followed by 3 months of postintervention assessment. Patients in the usual care and intervention groups visited the same pharmacy location, but the intervention pharmacist was instructed to have no contact with patients in the usual care group. The institutional review boards of Indiana UniversityPurdue University and the University of North Carolina at Chapel Hill approved this study. Setting and Patients Indiana University Medical Group, Indianapolis, is an academic primary care group practice composed of primary and specialty care clinics affiliated with Wishard Health Services. Faculty physicians, residents, and nurse practitioners provide care to 13000 adults (mean age, 57 years [SD, 15]; 60% women; 50% African American). Annually, these patients make approximately 50000 visits to practices, 72000 visits to emergency departments, and 135000 visits to pharmacies and have 16000 hospitalizations. We recruited patients from 4 identical general medicine practices, 1 cardiology practice, and Wishard Memorial Hospital. Practices met in half-day sessions per week that were attended by 2 or 3 faculty members and 3 to 5 residents or fellows from each practice. Faculty physicians practiced 1 to 5 half-days per week, whereas fellows practiced 1 to 2 half-days per week and residents attended the practice 1 half-day per week. Outpatients of Wishard Health Services fill their prescriptions at central or decentralized outpatient pharmacies located at the ambulatory care center or at 1 of several satellite pharmacies stationed at neighborhood clinics. Fully stocked decentralized pharmacies serviced all study patients. From February 2001 to January 2003, the study pharmacy was located in a building adjacent to the ambulatory care center. From February 2003 to June 2004, the study pharmacy was moved to a space adjacent to the general medicine practices in the ambulatory care center. Two pharmacists and 1 technician were stationed at the pharmacy. The study pharmacist was instructed to service patients in the intervention group only, and a second pharmacist serviced patients in the usual care group and filled prescriptions to be delivered to patients at outlying clinics. The technician filled prescriptions and read electronic adherence monitors. Weekly lists of eligible patients were created by using the Regenstrief Medical Record System (Regenstrief Institute, Indianapolis, Indiana) (14, 15). We invited clinically stable patients from general internal medicine practices, a cardiology clinic, and Wishard Memorial Hospital (at discharge) to participate in the study. Of 3034 patients with a diagnosis of heart failure, 1512 met criteria for enrollment. Patients were eligible if they were 50 years of age or older; planned to receive all of their care, including prescribed medications, at Wishard Health Services; had a diagnosis of heart failure confirmed by their primary care physician; regularly used at least 1 cardiovascular medication for heart failure (angiotensin-converting enzyme [ACE] inhibitor or angiotensin-receptor blocker, -adrenergic antagonist, diuretic, digoxin, or aldosterone antagonist); were not using or were not planning to use a medication container adherence aid (for example, a pill box); had access to a working telephone; and could hear within the range of normal conversation. We excluded patients with dementia. Patients received their prescription medications through state and local assistance plans at no cost. Thus, cost of medicines was not a deterrent to adherence. Randomization A trained interviewer conducted a baseline interview at enrollment. Interviewers were blinded to patients' study status and played no role in the delivery of the intervention. Interviewers contacted a centralized data manager at the end of each interview to determine the patient's study assignment, which was otherwise concealed. We randomly assigned patients, without blocking or stratification, to receive the pharmacy intervention or usual care by using a univariate discrete distribution from the IMSL Fortran Library's subroutine RNGDA pseudorandom number generator (Absoft Corp., Rochester Hills, Michigan) (16). We randomly assigned more patients to the usual care group so that this group could also be a prospective cohort for studying risk factors associated with the clinical deterioration of heart failure. Of the 314 patients included in the study, 229 were recruited from the general internal medicine practices, 15 from the cardiology clinic, and 70 on discharge from the Wishard Memorial Hospital. The numbers of patients assigned to the intervention and usual care groups did not differ by recruitment site (P= 0.83). Intervention A pharmacist delivered the intervention by using a protocol (Appendix Table 1) that included a baseline medication history of all prescription and over-the-counter drugs and dietary supplements taken by patients, which patients brought with them to the baseline interview, and the results of an assessment of patient medication knowledge and skills (7, 8). The pharmacist dispensed enough of the patient's medications to last approximately 2 months. Appendix Table 1. Pharmacist's Intervention Protocol* When medications were dispensed, the pharmacist provided patient-centered verbal instructions and written materials about the medications (11, 13, 17) by using a schema for instruction that has been tested (18, 19). We assigned each medication category an icon (for example, the icon for ACE inhibitors was a red ace of hearts). The same icon appeared on the container label and lid and on the written patient instructions. Written instructions were aimed at patients with low health literacy and contained an easy-to-follow timeline to remind patients when to take their medications (13). The pharmacist monitored patients' medication use, health care encounters, body weight, and other relevant data by using a study database (20, 21). Information about patients was communicated as needed to clinic nurses and primary care physicians by face-to-face visits, telephone, paging (physician only), and e-mail (physician only). Technicians supported the pharmacist's dispensing efforts within the pharmacy throughout the study. We incorporated costs therein into the economic analysis. Pharmacists serviced patients in the usual care group who were not associated with the intervention or the study. An interdisciplinary team of investigators that included pharmacists with advanced training in patient education and cardiovascular pharmacotherapy, a geriatrician, a cardiologist with expertise in heart failure, a behavioral scientist, and a cognitive psychologist trained the intervention pharmacist. The intervention pharmacist also studied guidelines for treating heart failure (22), key concepts in the pharmaceutical care of older adults, communication techniques, and the pharmacotherapy of the cardiovascular drugs for heart failure. All pharmacists at Wishard Health Services were aware of the study and were instructed on how to handle and redirect intervention patients who inadvertently arrived at their pharmacy. Usual Care Patients in the usual care group were aware of the purpose of the study, and their primary care phys