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Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.

ABSTRACT: Introduction:Health disparities in African-American (AA) kidney transplant recipients compared with non-AA recipients are well established. Cardiovascular disease (CVD) risk control is a significant mediator of this disparity. Objective:To assess the efficacy of improved medication safety, CVD risk control, and racial disparities in kidney transplant recipients. Methods:Prospective, pharmacist-led, technology-aided, 6-month interventional clinical trial. A total of 60 kidney recipients with diabetes and hypertension were enrolled. Patients had to be at least one-year post transplant with stable graft function. Primary outcome measured included hypertension, diabetes, and lipid control using intent-to-treat analyses, with differences assessed between AA and non-AA recipients. Results:The participants mean age was 59 years, with 42% being female and 68% being AA. Overall, patients demonstrated improvements in blood pressure <140/90 mmHg (baseline 50% vs. end of study 68%, p=0.054) and hemoglobin A1c <7% (baseline 33% vs. end of study 47%, p=0.061). AAs demonstrated a significant reduction from baseline in systolic blood pressure (-0.86 mmHg per month, p=0.026), which was not evident in non-AAs (-0.13 mmHg per month, p=0.865). Mean HgbA1c decreased from baseline in the overall group (-0.12% per month, p=0.003), which was similar within AAs (-0.11% per month, p=0.004) and non-AAs (-0.14% per month, p=0.029). There were no changes in low-density lipoproteins, triglycerides, or high-density lipoproteins over the course of the study. Medication errors were significantly reduced and self-reported medication adherence significantly improved over the course of the study. Conclusion:These results demonstrate the potential efficacy of a pharmacist-led, technology-aided, educational intervention in improving medication safety, diabetes, and hypertension and reducing racial disparities in AA kidney transplant recipients. (ClinicalTrials.gov NCT02763943).

SUBMITTER: Taber DJ

PROVIDER: S-EPMC6350824 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.

Taber David J DJ Gebregziabher Mulugeta M Posadas Aurora A Schaffner Caitlin C Egede Leonard E LE Baliga Prabhakar K PK

Journal of the American College of Clinical Pharmacy : JACCP 20180621 2

<h4>Introduction</h4>Health disparities in African-American (AA) kidney transplant recipients compared with non-AA recipients are well established. Cardiovascular disease (CVD) risk control is a significant mediator of this disparity.<h4>Objective</h4>To assess the efficacy of improved medication safety, CVD risk control, and racial disparities in kidney transplant recipients.<h4>Methods</h4>Prospective, pharmacist-led, technology-aided, 6-month interventional clinical trial. A total of 60 kidne ...[more]

PMID: 30714026

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Project description:BackgroundAlthough kidney transplant improves reproductive function in women with end-stage kidney disease (ESKD), pregnancy in kidney transplant recipients' remains challenging due to the risk of adverse maternal and fetal outcomes.MethodsWe evaluated a retrospective cohort of 7,966 women who were aged 15-45 years and received a kidney transplant between January 1, 2005 and December 31, 2011 from the United States Renal Data System with Medicare as the primary payer for the entire three years after the date of transplantation. Unadjusted and adjusted rates of pregnancy in the first three post-transplant years were calculated, using Poisson regression for the adjustment. Factors associated with pregnancy, including race, were examined using logistic regression.ResultsOverall, 293 pregnancies were identified in 7966 women. The unadjusted pregnancy rate was 13.8 per thousand person-years (PTPY) (95% confidence interval (CI), 12.3-15.5). Pregnancy rates were roughly constant in the years 2005-2011 except in 2005 and 2010. The rate of pregnancy was highest in Hispanic women (21.4 PTPY; 95% CI, 17.2-26.4) and Hispanic women had a higher likelihood of pregnancy as compared to white women (OR, 1.56; CI, 1.12-2.16). Pregnancy rates were lowest in women aged 30-34 years and 35-45 years at transplant, and women aged 30-34 years and 35-45 years at transplant were less likely to ever become pregnant during the follow-up (odds ratio [OR], 0.69; CI, 0.49-0.98 and OR, 0.14; CI 0.09-0.21 respectively) as compared to women aged 25-29 years at time of transplant. Women had higher rates of pregnancy in the second and third-year post-transplant (16.0 PTPY, CI 13.2-19.2 and 16.9 PTPY, CI 14.0-20.4) than in the first-year post-transplant (9.0 PTPY, CI 7.0-11.4). In transplant recipients, pregnancy was more likely in women with ESKD due to cystic disease (OR, 2.42; CI, 1.02-5.74) or glomerulonephritis (OR, 2.14; CI, 1.07-4.31) as compared to women with ESKD due to diabetes.ConclusionHispanic race, younger age, and ESKD cause due to cystic disease or glomerulonephritis are significant factors associated with a higher likelihood of pregnancy. Pregnancy rates have been fairly constant over the last decade. This study improves our understanding of factors associated with pregnancy in kidney transplant recipients.

Project description:Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention.In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; ? blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299.72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a ? blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months.The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records.Patient Safety Research Portfolio, Department of Health, England.

Project description: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.

Dataset Information

Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.

Publications

Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.

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