Rationale and Design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) Study

Abstract

Background— Medication errors and adverse drug events are common after hospital discharge due to changes in medication regimens, suboptimal discharge instructions, and prolonged time to follow-up. Pharmacist-based interventions may be effective in promoting the safe and effective use of medications, especially among high-risk patients such as those with low health literacy. Methods and Results— The Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study is a randomized controlled trial conducted at 2 academic centers—Vanderbilt University Hospital and Brigham and Women’s Hospital. Patients admitted with acute coronary syndrome or acute decompensated heart failure were randomly assigned to usual care or intervention. The intervention consisted of pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and tailored telephone follow-up after discharge. The primary outcome is the occurrence of serious medication errors in the first 30 days after hospital discharge. Secondary outcomes are health care utilization, disease-specific quality of life, and cost-effectiveness. Enrollment was completed September 2009. A total of 862 patients were enrolled, and 430 patients were randomly assigned to receive the intervention. Analyses will determine whether the intervention was effective in reducing serious medication errors, particularly in patients with low health literacy. Conclusions— The PILL-CVD study was designed to reduce serious medication errors after hospitalization through a pharmacist-based intervention. The intervention, if effective, will inform health care facilities on the use of pharmacist-assisted medication reconciliation, inpatient counseling, low-literacy adherence aids, and patient follow-up after discharge. Clinical Trial Registration— clinicaltrials.gov. Identifier: NCT00632021.

Post-Discharge Adverse Events Among Urban and Rural Patients of an Urban Community Hospital: A Prospective Cohort Study

“…2,3 While this may be due to temporal trends or differences in the health systems or patient populations, the difference may also be in the extensive review of outpatient health records in the present study; such differences were used to explain higher rates of post-discharge ADEs in a different study. 13 Consistent with previous studies is the finding that the majority of post-discharge AEs are preventable or ameliorable. Interestingly, the number of secondary discharge diagnoses was more strongly associated with AE risk in urban than in rural patients.…”

“…12 Potential subjects were identified from hospital administrative data. In order to ensure that equal proportions of urban and rural subjects were recruited, based on methods utilized in prior studies by these investigators, 13 nursereviewers first stratified the patient list by urban/rural, then randomized the order in which potentially eligible patients from the list were approached to ensure unbiased patient enrollment, and finally over-sampled rural patients to ensure that equal proportions of urban and rural patients were recruited. Prior to discharge, nurse-reviewers obtained informed written consent from study subjects, including a release to allow researchers to review health records from other institutions in the month after discharge, and then administered a brief demographic survey regarding exposure variables difficult to obtain from health records, including education level, household income and living arrangements, transportation, and caregiver status.…”

Effect of Patient- and Medication-Related Factors on Inpatient Medication Reconciliation Errors

“…The rationale and design of this study, including a full description of inclusion and exclusion criteria, has been published. 16 Patients were eligible for inclusion in these analyses if they were randomized to the intervention arm and received pharmacist-assisted medication reconciliation during hospitalization.…”

Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial

“…12 The PILL-CVD (Pharmacist Intervention for Low Literacy in Cardiovascular Disease) study was designed to assess the impact of a tailored, pharmacist-delivered intervention on the number of clinically important medication errors following hospital discharge, health care utilization, and quality of life measures. 13 Components of the intervention included pharmacist medication reconciliation, inpatient counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge. While the intervention did not demonstrate an overall reduction in medication errors, individuals with low health literacy or impaired cognition were more likely to derive some benefit.…”

“…Full details of the PILL-CVD rationale and methods are described elsewhere. 13 The study was approved by the Vanderbilt University Institutional Review Board and the Partners Human Research Committee.…”