Results of a multicenter cluster-randomized controlled clinical trial testing the effectiveness of a bioinformatics-enabled pharmacist intervention in transplant recipients.

An ambulatory medication safety dashboard was developed to identify missing labs, concerning labs, drug interactions, nonadherence, and transitions in care. This system was tested in a 2-year, prospective, cluster-randomized, controlled multicenter study. Pharmacists at 5 intervention sites used the dashboard to address medication safety issues, compared with usual care provided at 5 control sites. A total of 2196 transplant events were included (1300 intervention vs 896 control). During the 2-year study, the intervention arm had a 11.3% (95% confidence interval, 7.1%-15.5%) absolute risk reduction of having ≥1 emergency department (ED) visit (44.2% vs 55.5%, respectively; P < .001, respectively) and a 12.3% (95% confidence interval, 8.2%-16.4%) absolute risk reduction of having ≥1 hospitalization (30.1% vs 42.4%, respectively; P < .001). In those with ≥1 event, the median ED visit rate (2 [interquartile range (IQR) 1, 5] vs 2 [IQR 1, 4]; P = .510) and hospitalization rate (2 [IQR 1, 3] vs 2 [IQR 1, 3]; P = .380) were similar. Treatment effect varied by comorbidity burden, previous ED visits or hospitalizations, and heart or lung recipients. A bioinformatics dashboard-enabled, pharmacist-led intervention reduced the risk of having at least one ED visit or hospitalization, predominantly demonstrated in lower risk patients.

A Randomized Control Trial Testing a Medication Safety Dashboard in Veteran Transplant Recipients.

INTRODUCTION: Medication errors, adverse events, and nonadherence in organ transplant recipients are common and can lead to suboptimal outcomes. A medication safety dashboard was developed to identify issues in medication therapy. RESEARCH QUESTIONS: Can a multicenter bioinformatics dashboard accurately identify clinically relevant medication safety issues in US military Veteran transplant recipients? DESIGN: The dashboard was tested through a 24-month, prospective, cluster-randomized controlled multicenter study. Pharmacists used the dashboard to identify and address potential medication safety issues, which was compared with usual care. RESULTS: Across the 10 sites (5 control sites and 5 intervention sites), 2012 patients were enrolled (1197 intervention vs 831 control). The mean age was 65 (10) years, 95% male, and 27% Black. The dashboard produced 18 132 alerts at a rate of 0.61(0.32) alerts per patient-month, ranging from 0.44 to 0.72 across the 5 intervention sites. Lab-based issues were most common (83.4%), followed by nonadherence (9.4%) and transitions in care (6.4%); 56% of alerts were addressed, taking an average of 43 (29) days. Common responses to alerts included those already resolved by another provider (N = 4431, 44%), the alert not clinically relevant (N = 3131, 31%), scheduling of follow-up labs (N = 591, 6%), and providing medication reconciliation/education (N = 99, 1%). Inaccurate flags significantly decreased over the study by a mean of -0.6% per month (95% CI -0.1 to -1.0; P = .0265), starting at 13.4% and ending at 2.6%. CONCLUSION: This multicenter cluster-randomized controlled trial demonstrated that a medication safety dashboard was feasibly deployable across the VA healthcare system, creating valid alerts.

Residing in a Food Desert and Adverse Cardiovascular Events in US Veterans With Established Cardiovascular Disease.

Residents living in a "food desert" are known to be at a higher risk for developing cardiovascular disease (CVD). However, national-level data regarding the influence of residing in a food desert in patients with established CVD is lacking. Data from veterans with established atherosclerotic CVD who received outpatient care in the Veterans Health Administration system between January 2016 and December 2021 were obtained, with follow-up information collected until May 2022 (median follow-up: 4.3 years). A food desert was defined using the United States Department of Agriculture criteria, and census tract data were used to identify Veterans in these areas. All-cause mortality and the occurrence of major adverse cardiovascular events (MACEs; a composite of myocardial infarction/stroke/heart failure/all-cause mortality) were evaluated as the co-primary end points. The relative risk for MACE in food desert areas was evaluated by fitting multivariable Cox models adjusted for age, gender, race, ethnicity, and median household income, with food desert status as the primary exposure. Of the 1,640,346 patients (mean age 72 years, women 2.7%, White 77.7%, Hispanic 3.4%), 25,7814 (15.7%) belonged to the food desert group. Patients residing in food deserts were younger; more likely to be Black (22% vs 13%)or Hispanic (4% vs 3.5%); and had a higher prevalence of diabetes mellitus (52.7% vs 49.8%), chronic kidney disease (31.8% vs 30.4%,) and heart failure (25.6% vs 23.8%). Adjusted for covariates, food desert patients had a higher risk of MACE (hazard ratio 1.040 [1.033 to 1.047]; p <0.001) and all-cause mortality (hazard ratio 1.032 [1.024 to 1.039]; p <0.001). In conclusion, we observed that a large proportion of US veterans with established atherosclerotic CVD reside in food desert census tracts. Adjusting for age, gender, race, and ethnicity, residing in food deserts was associated with a higher risk of adverse cardiac events and all-cause mortality.

Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Medication errors, adverse drug events, and nonadherence lead to increased health care utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in veteran transplant patients, interventions should address interorganizational system failures and provider-level and patient-level factors. OBJECTIVE: This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with usual care, in veteran organ transplant recipients. METHODS: This is a 24-month prospective, parallel-arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 5 sites will then be randomized to each study arm. Approximately, 1600 veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites. RESULTS: This study is ongoing. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021. CONCLUSIONS: With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. CLINICAL TRIAL: ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13821.

Heart Failure Transitions of Care: A Pharmacist-Led Post-Discharge Pilot Experience.

OBJECTIVE: To perform a pilot evaluation of a pharmacist-led, multidisciplinary transitional care clinic for heart failure (HF) patients. BACKGROUND: Transitions of care in HF should include: medication reconciliation, multidisciplinary care, early post-discharge follow-up, and prompt intervention on HF signs and symptoms. We hypothesized that combining these elements with optimization of medications would impact outcomes. METHODS: In the SERIOUS HF Medication Reconciliation Transitional Care Clinic (HF MRTCC), patients were seen by a clinical pharmacist trained in HF. The pharmacist performed medication reconciliation, a basic physical exam, and a HF symptom history. Medications were adjusted by the clinical pharmacist or medical provider. Data were retrospectively collected for a quality improvement evaluation of this novel clinic on medication discrepancies, medications optimized, and 30-day readmissions. Descriptive statistics and paired t-tests were used for medication doses. RESULTS: All patients (n=135) had a diagnosis of HF, 59% were recently discharged. The mean time from discharge to the clinic appointment was 10±6days, and the 30day all-cause readmission rate was 9%. Medication discrepancies were detected in 53% of patients. Medications were optimized in 70%, most frequently beta blockers, ace inhibitors, and diuretics. In patients with an ejection fraction ≤40%, significantly higher doses of beta blockers and ace inhibitors were prescribed after the clinic visit. CONCLUSION: The HF MRTCC identified and corrected numerous medication discrepancies, up-titrated medications, and was associated with a 30-day readmission rate of 9%. These encouraging pilot results are hypothesis-generating and warrant further controlled trials.

Diuretics for hypertension: Hydrochlorothiazide or chlorthalidone?

Thiazide diuretics are the cornerstone of treatment of hypertension in most patients. Hydrochlorothiazide is the most commonly used thiazide diuretic in the United States, but interest in chlorthalidone is increasing. The authors summarize the literature comparing these two agents.

Clinical pharmacy services in heart failure: an opinion paper from the Heart Failure Society of America and American College of Clinical Pharmacy Cardiology Practice and Research Network.

Heart failure (HF) care takes place in multiple settings, with a variety of providers, and generally involves patients who have multiple comorbidities. This situation is a "perfect storm" of factors that predispose patients to medication errors. The goals of this paper are to outline potential roles for clinical pharmacists in a multidisciplinary HF team, to document outcomes associated with interventions by clinical pharmacists, to recommend minimum training for clinical pharmacists engaged in HF care, and to suggest financial strategies to support clinical pharmacy services within a multidisciplinary team. As patients transition from inpatient to outpatient settings and between multiple caregivers, pharmacists can positively affect medication reconciliation and education, assure consistency in management that results in improvements in patient satisfaction and medication adherence, and reduce medication errors. For mechanical circulatory support and heart transplant teams, the Centers for Medicare and Medicaid Services considers the participation of a transplant pharmacology expert (e.g., clinical pharmacist) to be a requirement for accreditation, given the highly specialized and complex drug regimens used. Although reports of outcomes from pharmacist interventions have been mixed owing to differences in study design, benefits such as increased use of evidence-based therapies, decreases in HF hospitalizations and emergency department visits, and decreases in all-cause readmissions have been demonstrated. Clinical pharmacists participating in HF or heart transplant teams should have completed specialized postdoctoral training in the form of residencies and/or fellowships in cardiovascular and/or transplant pharmacotherapy, and board certification is recommended. Financial mechanisms to support pharmacist participation in the HF teams are variable. Positive outcomes associated with clinical pharmacist activities support the value of making this resource available to HF teams.

Clinical pharmacy services in heart failure: an opinion paper from the Heart Failure Society of America and American College of Clinical Pharmacy Cardiology Practice and Research Network.

BACKGROUND: Heart failure (HF) care takes place in multiple settings, with a variety of providers, and generally involves patients who have multiple comorbidities. This situation is a "perfect storm" of factors that predispose patients to medication errors. METHODS AND RESULTS: The goals of this paper are to outline potential roles for clinical pharmacists in a multidisciplinary HF team, to document outcomes associated with interventions by clinical pharmacists, to recommend minimum training for clinical pharmacists engaged in HF care, and to suggest financial strategies to support clinical pharmacy services within a multidisciplinary team. As patients transition from inpatient to outpatient settings and between multiple caregivers, pharmacists can positively affect medication reconciliation and education, assure consistency in management that results in improvements in patient satisfaction and medication adherence, and reduce medication errors. For mechanical circulatory support and heart transplant teams, the Centers for Medicare and Medicaid Services considers the participation of a transplant pharmacology expert (e.g., clinical pharmacist) to be a requirement for accreditation, given the highly specialized and complex drug regimens used. Although reports of outcomes from pharmacist interventions have been mixed owing to differences in study design, benefits such as increased use of evidence-based therapies, decreases in HF hospitalizations and emergency department visits, and decreases in all-cause readmissions have been demonstrated. Clinical pharmacists participating in HF or heart transplant teams should have completed specialized postdoctoral training in the form of residencies and/or fellowships in cardiovascular and/or transplant pharmacotherapy, and board certification is recommended. Financial mechanisms to support pharmacist participation in the HF teams are variable. CONCLUSIONS: Positive outcomes associated with clinical pharmacist activities support the value of making this resource available to HF teams.