Courtney Cawthon

Effect of a Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge: A Randomized Trial

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.

Psychometric properties of the brief health literacy screen in clinical practice.

ABSTRACTBACKGROUNDThe three-item Brief Health Literacy Screen (BHLS) has been validated in research settings, but not in routine practice, administered by clinical personnel.OBJECTIVEAs 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.PARTICIPANTSBeginning 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.MEASURESTrained 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 RESULTSCronbach’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.CONCLUSIONSThe BHLS, administered by nurses during routine clinical care, demonstrates adequate reliability and validity to be used as a health literacy measure.

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

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 Womens 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.

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

ABSTRACTBackgroundLittle research has examined the incidence, clinical relevance, and predictors of medication reconciliation errors at hospital admission and discharge.ObjectiveTo 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, ParticipantsWe 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 MeasuresPharmacists 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 ResultsOn 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).ConclusionsMedication 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.

Predictors of medication adherence postdischarge: the impact of patient age, insurance status, and prior adherence.

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.

Health Literacy and Mortality: A Cohort Study of Patients Hospitalized for Acute Heart Failure

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 for death among patients with low health literacy was 1.34 (95% CI 1.04, 1.73, P=0.02) compared to Brief Health Literacy Screen >9. 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.

Association of health literacy with elevated blood pressure: a cohort study of hospitalized patients.

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.

Association of Brief Health Literacy Screening and Blood Pressure in Primary Care

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.

Characteristics Associated With Postdischarge Medication Errors

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.

Implementing Routine Health Literacy Assessment in Hospital and Primary Care Patients

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.