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Background: Clinically important medication errors are common after hospital discharge. They include preventable or ameliorable adverse drug events (ADEs), as well as medication discrepancies or nonadherence with high potential for future harm (potential ADEs).Objective: To determine the effect of a tailored intervention on the occurrence of clinically important medication errors after hospital discharge.Design: Randomized, controlled trial with concealed allocation and blinded outcome assessors. (ClinicalTrials.gov registration number: NCT00632021)Setting: Two tertiary care academic hospitals.Patients: Adults hospitalized with acute coronary syndromes or acute decompensated heart failure.Intervention: Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge.Measurements: The primary outcome was the number of clinically important medication errors per patient during the first 30 days after hospital discharge. Secondary outcomes included preventable or ameliorable ADEs, as well as potential ADEs.Results: Among 851 participants, 432 (50.8%) had 1 or more clinically important medication errors; 22.9% of such errors were judged to be serious and 1.8% life-threatening. Adverse drug events occurred in 258 patients (30.3%) and potential ADEs in 253 patients (29.7%). The intervention did not significantly alter the per-patient number of clinically important medication errors (unadjusted incidence rate ratio, 0.92 [95% CI, 0.77 to 1.10]) or ADEs (unadjusted incidence rate ratio, 1.09 [CI, 0.86 to 1.39]). Patients in the intervention group tended to have fewer potential ADEs (unadjusted incidence rate ratio, 0.80 [CI, 0.61 to 1.04]).Limitation: The characteristics of the study hospitals and participants may limit generalizability.Conclusion: Clinically important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy-sensitive, pharmacist-delivered intervention.Primary Funding Source: National Heart, Lung, and Blood Institute. [ABSTRACT FROM AUTHOR]

Vagal afferent neurons (VAN), located in the nodose ganglion (NG) innervate the gut and terminate in the nucleus of solitary tract (NTS) in the brainstem. They are the primary sensory neurons integrating gut-derived signals to regulate meal size. Chronic high-fat diet (HFD) consumption impairs vagally mediated satiety, resulting in overfeeding. There is evidence that HFD consumption leads to alterations in both vagal nerve function and structural integrity. HFD also leads to marked gut microbiota dysbiosis; in rodent models, dysbiosis is sufficient to induce weight gain. In this study, we investigated the effect of microbiota dysbiosis on gut-brain vagal innervation independently of diet. To do so, we recolonized microbiota-depleted rats with gastrointestinal (GI) contents isolated from donor animals fed either a HFD (45 or 60% fat) or a low fat diet (LFD, 13% fat). We used two different depletion models while maintaining the animals on LFD: 1) conventionally raised Fischer and Wistar rats that underwent a depletion paradigm using an antibiotic cocktail and 2) germ free (GF) raised Fischer rats. Following recolonization, receiver animals were designated as ConvLF and ConvHF. Fecal samples were collected throughout these studies and analyzed via 16S Illumina sequencing. In both models, bacteria that were identified as characteristic of HFD were successfully transferred to recipient animals. Three weeks post-colonization, ConvHF rats showed significant increases in ionized calcium-binding adapter molecule-1 (Iba1) positive immune cells in the NG compared to ConvLF animals. Additionally, using isolectin B4 (IB4) staining to identify c-fibers, we found that, compared to ConvLF animals, ConvHF rats displayed decreased innervation at the level of the medial NTS; c-fibers at this level are believed to be primarily of vagal origin. This alteration in vagal structure was associated with a loss in satiety induced by the gut peptide cholecystokinin (CCK). Increased presence of immunocompetent Iba1 + cells along the gut-brain axis and alterations in NTS innervation were still evident in ConvHF rats compared to ConvLF animals 12 weeks post-colonization and were associated with increases in food intake and body weight (BW). We conclude from these data that microbiota dysbiosis can alter gut-brain vagal innervation, potentially via recruitment and/or activation of immune cells., Competing Interests: Declaration of Competing Interest The authors declare no potential conflict of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

(1) High-fat (HF) diet leads to gut microbiota dysbiosis which is associated with systemic inflammation. Bacterial-driven inflammation is sufficient to alter vagally mediated satiety and induce hyperphagia. Promoting bacterial fermentation improves gastrointestinal (GI) epithelial barrier function and reduces inflammation. Resistant starch escape digestion and can be fermented by bacteria in the distal gut. Therefore, we hypothesized that potato RS supplementation in HF-fed rats would lead to compositional changes in microbiota composition associated with improved inflammatory status and vagal signaling. (2) Male Wistar rats ( n = 8/group) were fed a low-fat chow (LF, 13% fat), HF (45% fat), or an isocaloric HF supplemented with 12% potato RS (HFRS) diet. (3) The HFRS-fed rats consumed significantly less energy than HF animals throughout the experiment. Systemic inflammation and glucose homeostasis were improved in the HFRS compared to HF rats. Cholecystokinin-induced satiety was abolished in HF-fed rats and restored in HFRS rats. HF feeding led to a significant decrease in positive c fiber staining in the brainstem which was averted by RS supplementation. (4) The RS supplementation prevented dysbiosis and systemic inflammation. Additionally, microbiota manipulation via dietary potato RS prevented HF-diet-induced reorganization of vagal afferent fibers, loss in CCK-induced satiety, and hyperphagia.

Overestimation of patients' health literacy skills is common among nurses and physicians. At Vanderbilt University Hospital, nurses routinely ask patients the 3 Brief Health Literacy Screen (BHLS) questions. Data from 2 studies that recruited patients at Vanderbilt University Hospital-the Health Literacy Screening (HEALS) study and the Vanderbilt Inpatient Cohort Study (VICS)-were analyzed to compare the BHLS score recorded by nurses during clinical care with the score recorded by trained research assistants during the same hospitalization. Logistic regression models determined which patient characteristics were associated with nurses documenting higher health literacy scores than research assistants. Overall, the majority (60%) of health literacy scores were accurate, though nurses recorded meaningfully higher health literacy scores in 28.4% of HEALS patients and 35.6% of VICS patients. In the HEALS cohort, patients who were male and had less education were more likely to have higher health literacy scores recorded by nurses (odds ratio [OR] = 1.93, 95% confidence interval [CI] [1.24, 3.00]; and OR = 0.80, 95% CI [0.74, 0.88], respectively). In the VICS cohort, patients who were older, were male, and had less education were more likely to have higher health literacy scores recorded by nurses (OR = 1.01, 95% CI [1.003, 1.02]; OR = 1.49, 95% CI [1.20, 1.84]; and OR = 0.87, 95% CI [0.83, 0.90], respectively). These findings suggest that health literacy scores recorded by nurses for male patients and patients with less education could be overestimated. Thus, health care professionals should be aware of this tendency and should verify the results of routine health literacy screening tests, especially in certain patient groups.

Objectives: To identify vulnerable cardiovascular patients in the hospital using a self-reported function-based screening tool., Participants: Prospective observational cohort study of 445 individuals aged ≥ 65 years admitted to a university medical centre hospital within the USA with acute coronary syndrome and/or decompensated heart failure., Methods: Participants completed an inperson interview during hospitalisation, which included vulnerable functional status using the Vulnerable Elders Survey (VES-13), sociodemographic, healthcare utilisation practices and clinical patient-specific measures. A multivariable proportional odds logistic regression model examined associations between VES-13 and prior healthcare utilisation, as well as other coincident medical and psychosocial risk factors for poor outcomes in cardiovascular disease., Results: Vulnerability was highly prevalent (54%) and associated with a higher number of clinic visits, emergency room visits and hospitalisations (all p<0.001). A multivariable analysis demonstrating a 1-point increase in VES-13 (vulnerability) was independently associated with being female (OR 1.55, p=0.030), diagnosis of heart failure (OR 3.11, p<0.001), prior hospitalisations (OR 1.30, p<0.001), low social support (OR 1.42, p=0.007) and depression (p<0.001). A lower VES-13 score (lower vulnerability) was associated with increased health literacy (OR 0.70, p=0.002)., Conclusions: Vulnerability to functional decline is highly prevalent in hospitalised older cardiovascular patients and was associated with patient risk factors for adverse outcomes and an increased use of healthcare services., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: More than 30% of patients hospitalized for heart failure are rehospitalized or die within 90 days of discharge. Lower health literacy is associated with mortality among outpatients with chronic heart failure; little is known about this relationship after hospitalization for acute heart failure., Methods and Results: Patients hospitalized for acute heart failure and discharged home between November 2010 and June 2013 were followed through December 31, 2013. Nurses administered the Brief Health Literacy Screen at admission; low health literacy was defined as Brief Health Literacy Screen ≤9. The primary outcome was all-cause mortality. Secondary outcomes were time to first rehospitalization and, separately, time to first emergency department visit within 90 days of discharge. Cox proportional hazards models determined their relationships with health literacy, adjusting for age, gender, race, insurance, education, comorbidity, and hospital length of stay. For the 1379 patients, average age was 63.1 years, 566 (41.0%) were female, and 324 (23.5%) had low health literacy. Median follow-up was 20.7 months (interquartile range 12.8 to 29.6 months), and 403 (29.2%) patients died. Adjusted hazard ratio [aHR] for death among patients with LHL was 1.32 (95%confidence interval [CI] 1.05, 1.66, P=0.02) compared to BHLS>9 [corrected].Within 90 days of discharge, there were 415 (30.1%) rehospitalizations and 201 (14.6%) emergency department visits, with no evident association with health literacy., Conclusions: Lower health literacy was associated with increased risk of death after hospitalization for acute heart failure. There was no evident relationship between health literacy and 90-day rehospitalization or emergency department visits., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objective: To examine the association of patient- and medication-related factors with postdischarge medication errors., Patients and Methods: The Vanderbilt Inpatient Cohort Study includes adults hospitalized with acute coronary syndromes and/or acute decompensated heart failure. We measured health literacy, subjective numeracy, marital status, cognition, social support, educational attainment, income, depression, global health status, and medication adherence in patients enrolled from October 1, 2011, through August 31, 2012. We used binomial logistic regression to determine predictors of discordance between the discharge medication list and the patient-reported list during postdischarge medication review., Results: Among 471 patients (mean age, 59 years), the mean total number of medications reported was 12, and 79 patients (16.8%) had inadequate or marginal health literacy. A total of 242 patients (51.4%) were taking 1 or more discordant medication (ie, appeared on either the discharge list or patient-reported list but not both), 129 (27.4%) failed to report a medication on their discharge list, and 168 (35.7%) reported a medication not on their discharge list. In addition, 279 participants (59.2%) had a misunderstanding in indication, dose, or frequency in a cardiac medication. In multivariable analyses, higher subjective numeracy (odds ratio [OR], 0.81; 95% CI, 0.67-0.98) was associated with lower odds of having discordant medications. For cardiac medications, participants with higher health literacy (OR, 0.84; 95% CI, 0.74-0.95), with higher subjective numeracy (OR, 0.77; 95% CI, 0.63-0.95), and who were female (OR, 0.60; 95% CI, 0.46-0.78) had lower odds of misunderstandings in indication, dose, or frequency., Conclusion: Medication errors are present in approximately half of patients after hospital discharge and are more common among patients with lower numeracy or health literacy., (Copyright © 2014 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Background: The clinical consequences of low health literacy are not fully understood., Objectives: We evaluated the relationship between low health literacy and elevated blood pressure (BP) at hospital presentation., Research Design and Subjects: We conducted a cross-sectional evaluation of adult patients hospitalized at a university hospital between November 1, 2010 and April 30, 2012., Measures: Health literacy was assessed using the Brief Health Literacy Screen (BHLS). Low health literacy was defined as a BHLS score ≤9. BP was assessed using clinical measurements. The outcome was elevated BP (≥140/90 mm Hg; ≥130/80 mm Hg with diabetes or renal disease) or extremely elevated BP (>160/100 mm Hg) at hospital presentation. Multivariate logistic regression adjusted for age, sex, race, insurance, comorbidities, and antihypertensive medications; preplanned restricted analysis among patients with diagnosed hypertension was performed., Results: Of 46,263 hospitalizations, 23% had low health literacy, which occurred more often among patients who were older (61 vs. 54 y), less educated (28.4% vs. 11.2% had not completed high school), and more often admitted through the emergency department (54.3% vs. 48.1%) than those with BHLS>9. Elevated BP was more frequent among those with low health literacy [40.0% vs. 35.5%; adjusted odds ratio (aOR) 1.06; 95% confidence interval (CI), 1.01-1.12]. Low health literacy was associated with extremely elevated BP (aOR 1.08; 95% CI, 1.01-1.16) and elevated BP among those without diagnosed hypertension (aOR 1.09; 95% CI, 1.02-1.16)., Conclusions: More than ⅓ of patients had elevated BP at hospital presentation. Low health literacy was independently associated with elevated BP, particularly among patients without diagnosed hypertension.

Background: Patients with inadequate health literacy often have poorer health outcomes and increased utilization and costs. The Institute of Medicine has recommended that health literacy assessment be incorporated into health care information systems, which would facilitate large-scale studies of the effects of health literacy, as well as evaluation of system interventions to improve care by addressing health literacy. As part of the Health Literacy Screening (HEALS) study, a Brief Health Literacy Screen (BHLS) was incorporated into the electronic health record (EHR) at a large academic medical center., Methods: Changes were implemented to the nursing intake documentation across all adult hospital units, the emergency department, and three primary care practices. The change involved replacing previous education screening items with the BHLS. Implementation was based on a quality improvement framework, with a focus on acceptability, adoption, appropriateness, feasibility, fidelity and sustainability. Support was gained from nursing leadership, education and training was provided, a documentation change was rolled out, feedback was obtained, and uptake of the new health literacy screening items was monitored., Results: Between November 2010 and April 2012, there were 55,611 adult inpatient admissions, and from November 2010 to September 2011, 23,186 adult patients made 39,595 clinic visits to the three primary care practices. The completion (uptake) rate was 91.8% for the hospital and 66.6% for the outpatient clinics., Conclusions: Although challenges exist, it is feasible to incorporate health literacy screening into clinical assessment and EHR documentation. Next steps are to evaluate the association of health literacy with processes and outcomes of care across inpatient and outpatient populations.

Background: The period following hospital discharge is a vulnerable time for patients when errors and poorly coordinated care are common. Suboptimal care transitions for patients admitted with cardiovascular conditions can contribute to readmission and other adverse health outcomes. Little research has examined the role of health literacy and other social determinants of health in predicting post-discharge outcomes., Methods: The Vanderbilt Inpatient Cohort Study (VICS), funded by the National Institutes of Health, is a prospective longitudinal study of 3,000 patients hospitalized with acute coronary syndromes or acute decompensated heart failure. Enrollment began in October 2011 and is planned through October 2015. During hospitalization, a set of validated demographic, cognitive, psychological, social, behavioral, and functional measures are administered, and health status and comorbidities are assessed. Patients are interviewed by phone during the first week after discharge to assess the quality of hospital discharge, communication, and initial medication management. At approximately 30 and 90 days post-discharge, interviewers collect additional data on medication adherence, social support, functional status, quality of life, and health care utilization. Mortality will be determined with up to 3.5 years follow-up. Statistical models will examine hypothesized relationships of health literacy and other social determinants on medication management, functional status, quality of life, utilization, and mortality. In this paper, we describe recruitment, eligibility, follow-up, data collection, and analysis plans for VICS, as well as characteristics of the accruing patient cohort., Discussion: This research will enhance understanding of how health literacy and other patient factors affect the quality of care transitions and outcomes after hospitalization. Findings will help inform the design of interventions to improve care transitions and post-discharge outcomes.

Background: The three-item Brief Health Literacy Screen (BHLS) has been validated in research settings, but not in routine practice, administered by clinical personnel., Objective: As part of the Health Literacy Screening (HEALS) study, we evaluated psychometric properties of the BHLS to validate its administration by clinical nurses in both clinic and hospital settings., Participants: Beginning in October 2010, nurses in clinics and the hospital at an academic medical center have administered the BHLS during patient intake and recorded responses in the electronic health record., Measures: Trained research assistants (RAs) administered the short Test of Functional Health Literacy in Adults (S-TOFHLA) and re-administered the BHLS to convenience samples of hospital and clinic patients. Analyses included tests of internal consistency reliability, inter-administrator reliability, and concurrent validity by comparing the nurse-administered versus RA-administered BHLS scores (BHLS-RN and BHLS-RA, respectively) to the S-TOFHLA., Key Results: Cronbach's alpha for the BHLS-RN was 0.80 among hospital patients (N = 498) and 0.76 among clinic patients (N = 295), indicating high internal consistency reliability. Intraclass correlation between the BHLS-RN and BHLS-RA among clinic patients was 0.77 (95 % CI 0.71-0.82) and 0.49 (95 % CI 0.40-0.58) among hospital patients. BHLS-RN scores correlated significantly with BHLS-RA scores (r = 0.33 among hospital patients; r = 0.62 among clinic patients), and with S-TOFHLA scores (r = 0.35 among both hospital and clinic patients), providing evidence of inter-administrator reliability and concurrent validity. In regression models, BHLS-RN scores were significant predictors of S-TOFHLA scores after adjustment for age, education, gender, and race. Area under the receiver operating characteristic curve for BHLS-RN to predict adequate health literacy on the S-TOFHLA was 0.71 in the hospital and 0.76 in the clinic., Conclusions: The BHLS, administered by nurses during routine clinical care, demonstrates adequate reliability and validity to be used as a health literacy measure.

Health literacy impacts health outcomes. However, the relationship to blood pressure is inconsistent. This study aimed to determine whether health literacy, assessed by clinic staff, is associated with blood pressure among patients with hypertension. The design was a cross-sectional study of a large sample of primary care patient encounters in 3 academic medical center clinics in Nashville, Tennessee. Health literacy was assessed using the Brief Health Literacy Screen, with higher scores indicating higher health literacy. Blood pressure was extracted from the electronic health record. Using 23,483 encounters in 10,644 patients, the authors examined the association of health literacy with blood pressure in multivariable analyses, adjusting for age, gender, race, education, and clinic location. Independent of educational attainment, 3-point increases in health literacy scores were associated with 0.74 mmHg higher systolic blood pressure (95% CI [0.38, 1.09]) and 0.30 mmHg higher diastolic blood pressure (95% CI [0.08, 0.51]). No interaction between education and health literacy was observed (p = .91). In this large primary care population of patients with hypertension, higher health literacy, as screened in clinical practice, was associated with a small increase in blood pressures. Future research is needed to explore this unexpected finding.

Background: Increasingly, hospitals are implementing multifaceted programs to improve medication reconciliation and transitions of care, often involving pharmacists., Objective: To assess pharmacists' views on their roles in hospital-based medication reconciliation and discharge counseling and provide their recommendations for improving care transitions., Methods: Eleven study pharmacists at 2 hospitals participated in the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study and completed semistructured one-on-one interviews, which were coded systematically in NVivo. Pharmacists provided their perspectives on admission and discharge medication reconciliation, in-hospital patient counseling, provision of simple medication adherence aids (eg, pill box, illustrated daily medication schedule), and telephone follow-up., Results: Pharmacists indicated that they considered medication reconciliation, although time consuming, to be their most important role in improving care transitions, particularly through detection of errors that required correction in the admission medication history. They also identified patients who required additional counseling because of poor understanding of their medications. Providing adherence aids was felt to be highly valuable for patients with low health literacy, although less useful for patients with adequate health literacy. Pharmacists noted that having trained administrative staff conduct initial postdischarge follow-up calls to screen for issues and triage which patients needed pharmacist follow-up was helpful and an efficient use of resources. Pharmacists' recommendations for improving care transitions included clear communication among team members, protected time for discharge counseling, patient and family engagement in discharge counseling, and provision of patient education materials., Conclusions: Pharmacists are well positioned to participate in hospital-based medication reconciliation, identify patients with poor medication understanding or adherence, and provide tailored patient counseling to improve transitions of care. Additional studies are needed to confirm these findings in other settings and to determine the efficacy and cost-effectiveness of different models of pharmacist involvement.

Background: Little research has examined the incidence, clinical relevance, and predictors of medication reconciliation errors at hospital admission and discharge., Objective: To identify patient- and medication-related factors that contribute to pre-admission medication list (PAML) errors and admission order errors, and to test whether such errors persist in the discharge medication list., Design, Participants: We conducted a cross-sectional analysis of 423 adults with acute coronary syndromes or acute decompensated heart failure admitted to two academic hospitals who received pharmacist-assisted medication reconciliation during the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) Study., Main Measures: Pharmacists assessed the number of total and clinically relevant errors in the PAML and admission and discharge medication orders. We used negative binomial regression and report incidence rate ratios (IRR) of predictors of reconciliation errors., Key Results: On admission, 174 of 413 patients (42%) had ≥1 PAML error, and 73 (18%) had ≥1 clinically relevant PAML error. At discharge, 158 of 405 patients (39%) had ≥1 discharge medication error, and 126 (31%) had ≥1 clinically relevant discharge medication error. Clinically relevant PAML errors were associated with older age (IRR = 1.46; 95% CI, 1.00- 2.12) and number of pre-admission medications (IRR = 1.17; 95% CI, 1.10-1.25), and were less likely when a recent medication list was present in the electronic medical record (EMR) (IRR = 0.54; 95% CI, 0.30-0.96). Clinically relevant admission order errors were also associated with older age and number of pre-admission medications. Clinically relevant discharge medication errors were more likely for every PAML error (IRR = 1.31; 95% CI, 1.19-1.45) and number of medications changed prior to discharge (IRR = 1.06; 95% CI, 1.01-1.11)., Conclusions: Medication reconciliation errors are common at hospital admission and discharge. Errors in preadmission medication histories are associated with older age and number of medications and lead to more discharge reconciliation errors. A recent medication list in the EMR is protective against medication reconciliation errors.

Background: Optimizing postdischarge medication adherence is a target for avoiding adverse events. Nevertheless, few studies have focused on predictors of postdischarge medication adherence., Methods: The Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study used counseling and follow-up to improve postdischarge medication safety. In this secondary data analysis, we analyzed predictors of self-reported medication adherence after discharge. Based on an interview at 30-days postdischarge, an adherence score was calculated as the mean adherence in the previous week of all regularly scheduled medications. Multivariable linear regression was used to determine the independent predictors of postdischarge adherence., Results: The mean age of the 646 included patients was 61.2 years, and they were prescribed an average of 8 daily medications. The mean postdischarge adherence score was 95% (standard deviation [SD] = 10.2%). For every 10-year increase in age, there was a 1% absolute increase in postdischarge adherence (95% confidence interval [CI] 0.4% to 2.0%). Compared to patients with private insurance, patients with Medicaid were 4.5% less adherent (95% CI -7.6% to -1.4%). For every 1-point increase in baseline medication adherence score, as measured by the 4-item Morisky score, there was a 1.6% absolute increase in postdischarge medication adherence (95% CI 0.8% to 2.4%). Surprisingly, health literacy was not an independent predictor of postdischarge adherence., Conclusions: In patients hospitalized for cardiovascular disease, predictors of lower medication adherence postdischarge included younger age, Medicaid insurance, and baseline nonadherence. These factors can help predict patients who may benefit from further interventions., (Copyright © 2012 Society of Hospital Medicine.)

After hospital discharge, patients commonly suffer potentially avoidable adverse events and hospital readmissions. As hospitals implement interventions to improve discharge transitions, it is important to understand patients' perspectives on which intervention components are most beneficial. This study examined a sample of 125 patients randomized to the intervention arm of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease study who completed a telephone survey about the helpfulness of different components of the intervention, which included medication reconciliation, inpatient counseling, simple adherence aids, and telephone follow-up. The majority of patients indicated that it was "very helpful" to speak with a pharmacist about their medications before discharge (72.8%), particularly about how to take the medications and how to prevent and manage side effects. Receiving an illustrated medication list (69.6%) and a follow-up phone call after discharge (68.0%) were also considered very helpful. Patients with limited health literacy indicated the greatest benefit. Patients also reported feeling more comfortable speaking with their outpatient providers about their medications after receiving the intervention. In conclusion, patients--particularly those with limited health literacy--found a hospital pharmacist-based intervention to be very helpful and empowering.

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.