The Role of Carbamoyl Phosphate Synthetase 1 as a Prognostic Biomarker in Patients With Acetaminophen-induced Acute Liver Failure.

BACKGROUND & AIMS: Carbamoyl phosphate synthetase 1 (CPS1) is a highly abundant mitochondrial urea cycle enzyme that is expressed primarily in hepatocytes. CPS1 is constitutively and physiologically secreted into bile but is released into the bloodstream upon acute liver injury (ALI). Given its abundance and known short half-life, we tested the hypothesis that it may serve as a prognostic serum biomarker in the setting of acute liver failure (ALF). METHODS: CPS1 levels were determined using enzyme-linked immunosorbent assay and immunoblotting of sera collected by the ALF Study Group (ALFSG) from patients with ALI and ALF (103 patients with acetaminophen and 167 non-acetaminophen ALF etiologies). A total of 764 serum samples were examined. The inclusion of CPS1 was compared with the original ALFSG Prognostic Index by area under the receiver operating characteristic curve analysis. RESULTS: CPS1 values for acetaminophen-related patients were significantly higher than for non-acetaminophen patients (P < .0001). Acetaminophen-related patients who received a liver transplant or died within 21 days of hospitalization exhibited higher CPS1 levels than patients who spontaneously survived (P = .01). Logistic regression and area under the receiver operating characteristic analysis of CPS1 enzyme-linked immunosorbent assay values improved the accuracy of the ALFSG Prognostic Index, which performed better than the Model for End-Stage Liver Disease, in predicting 21-day transplant-free survival for acetaminophen- but not non-acetaminophen-related ALF. An increase of CPS1 but not alanine transaminase or aspartate transaminase, when comparing day 3 with day 1 levels was found in a higher percentage of acetaminophen transplanted/dead patients (P < .05). CONCLUSION: Serum CPS1 determination provides a new potential prognostic biomarker to assess patients with acetaminophen-induced ALF.

Alignment of an interprofessional student learning experience with a hospital quality improvement initiative.

Assessment of interprofessional education (IPE) frequently focuses on students' learning outcomes including changes in knowledge, skills, and/or attitudes. While a foundational education in the values and information of their chosen profession is critical, interprofessional learning follows a continuum from formal education to practice. The continuum increases in significance and complexity as learning becomes more relationship based and dependent upon the ability to navigate complex interactions with patients, families, communities, co-workers, and others. Integrating IPE into collaborative practice is critical to enhancing students' experiential learning, developing teamwork competencies, and understanding the complexity of teams. This article describes a project that linked students with a hospital-based quality-improvement effort to focus on the acquisition and practice of teamwork skills and to determine the impact of teamwork on patient and quality outcome measures. A hospital unit was identified with an opportunity for improvement related to quality care, patient satisfaction, employee engagement, and team behaviours. One hundred and thirty-seven students from six health profession colleges at the Medical University of South Carolina underwent TeamSTEPPS® training and demonstrated proficiency of their teamwork-rating skills with the TeamSTEPPS® Team Performance Observation Tool (T-TPO). Students observed real-time team behaviours of unit staff before and after staff attended formal TeamSTEPPS® training. The students collected a total of 778 observations using the T-TPO. Teamwork performance on the unit improved significantly across all T-TPO domains (team structure, communication, leadership, situation monitoring, and mutual support). Significant improvement in each domain continued post-intervention and at 15-month follow-up, improvement remained significant compared to baseline. Student engagement in TeamSTEPPS® training and demonstration of their reliability as teamwork-observers was a valuable learning experience and also yielded an opportunity to gather unique, and otherwise difficult to attain, data from a hospital unit for use by quality managers and administrators.

Preventive Care Utilization by Patients Who Use Virtual Urgent Care.

Introduction: The use of direct to patient (DTP) telemedicine for common acute conditions is widespread. It provides certain advantages over in-person visits, but has led to concerns about fragmentation of care. It is unknown whether use of DTP telemedicine decreases use of primary care services in a way that leads to missed preventive screenings and immunizations. Methods: Virtual urgent care (VUC) is a DTP telemedicine service to treat common acute conditions. All VUC encounters completed at an academic health system from July 2018 to December 2019 were evaluated and analyzed in 2020. Only patients established with primary care (at least one primary care visit in the same year as VUC encounter) were included. Specific preventive screenings (breast cancer, gonorrhea/chlamydia, and cervical cancer) and immunizations (tetanus and influenza) were characterized as up to date based on national guidelines. Chi-squares and multivariate logistic regressions were used to assess receipt of screenings and immunizations. Regressions included VUC and primary care utilization and demographic factors. Results: Patients evaluated (N = 1025) were mostly 25-50 years old (69.7%), women (81.8%), and white (74.9%). More than half (56.5%) had only used VUC once. In multivariate analyses, VUC utilization was not negatively associated with any of the preventive services evaluated, whereas primary care utilization was associated with receipt of both immunizations and gonorrhea/chlamydia screening. Conclusions: Higher VUC utilization is not negatively associated with receipt of preventive services, as long as a primary care relationship is established. VUC may provide a useful method of encouraging receipt of preventive services, especially for younger patients.

Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients.

This was an economic analysis of a 12-month, parallel arm, randomized controlled trial in adult kidney recipients 6 to 36 months posttransplant (NCT03247322). All participants received usual posttransplant care, while the intervention arm received supplemental clinical pharmacist-led medication therapy monitoring and management, via a smartphone-enabled mHealth app, integrated with risk-based televisits. Hospitalization charges were captured from the study institution accounts payable and non-study institution hospitalization charges were estimated using multiple imputation. Multivariable modeling was used to assess the impact of the intervention on charges. The intervention significantly reduced rates of hospitalization (1.08 per patient-year in the control arm vs 0.65 per patient-year in the intervention arm, p = .007). The control arm had estimated hospitalization costs of $870,468 vs $390,489 in the intervention arm. Modeling demonstrated a 49% lower hospitalization charge risk in the intervention arm (RR 0.51, 95% CI 0.28-0.91; p = .022). From a payer or societal perspective, the net estimated cost savings, after accounting for intervention delivery costs, was $368,839, with a return on investment (ROI) of $4.30 for every $1 spent. These results demonstrate that a mHealth-enabled, pharmacist-led intervention significantly reduced hospitalization costs for payers over a 12-month period and has a positive ROI.

Etiologies and Outcomes Associated With Tacrolimus Levels Out of a Typical Range That Lead to High Variability in Kidney Transplant Recipients.

BACKGROUND: High tacrolimus intrapatient variability (tac IPV) is associated with poor outcomes in kidney transplantation, including rejection, donor-specific antibodies, and graft loss. A common cause of high tac IPV is related to patient nonadherence, but this is yet to be conclusively demonstrated. METHODS: This was a longitudinal cohort study comprising adult kidney recipients, who received transplants between 2015 and 2017, with follow-ups through February 2020. The goal of this study was to identify the most common etiologies of tac levels outside the typical range, which lead to high tac IPV, and assess the etiology-specific associations between high tac IPV and graft outcomes. Multivariate Cox regression was used to assess time-to-event analyses. RESULTS: In total, 537 adult kidney recipients were included; 145 (27%) were identified as having a high tac IPV (>40%) 3-102 months post-transplant. Common etiologies of tac levels significantly outside the standard goal range (6-12 ng/mL) leading to high tac IPV included patient nonadherence (20%), infections (19%), tac-related toxicities (17%), and undocumented issues (27%). In multivariable Cox modeling, those with high tac IPV because of nonadherence had a 3.5 times higher risk of late acute rejection (P = 0.019) and 2.2 times higher risk of late graft loss (P = 0.044). No other etiologies in the typical tac level range were significantly associated with either acute rejection or graft loss. CONCLUSIONS: Although high tac IPV has many causes, only high tac IPV caused by nonadherence is consistently associated with poor allograft outcomes.

Patterns of emergency department utilization between transplant and non-transplant centers and impact on clinical outcomes in kidney recipients.

There is a high rate of Emergency Department (ED) utilization in kidney recipients post-transplant; ED visits are associated with readmission rates and lower survival rates. However, utilization within and outside transplant centers may lead to different outcomes. The objective was to analyze ED utilization patterns at transplant and non-transplant centers as well as common etiologies of ED visits and correlation with hospitalization, graft, and patient outcomes. This was a longitudinal, retrospective, single-center cohort study in kidney transplant recipients evaluating ED utilization. Comparator groups were determined by ED location, time from transplant, and disposition/readmission from ED visit. 1,106 kidney recipients were included in the study. ED utilization dropped at the transplant center after the 1st year (P < .001), while remaining at a similar rate at non-transplant centers (0.22 vs 1.06 VPPY). Infection and allograft complications were the most common causes of ED visits. In multivariable Cox modeling, an ED visit due to allograft complication at a non-transplant center >1 year post-transplant was associated with higher risk for graft loss and death (aHR 2.93 and aHR 1.75, P < .0001). The results of this study demonstrate an increased risk of graft loss among patients who utilize non-transplant center emergency departments. Improved communication and coordination between transplant centers and non-transplant centers may contribute to better long-term outcomes.

Preliminary assessment of safety and adherence to a once-daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study.

Medication non-adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once-daily immunosuppression regimen of Extended-release-tacrolimus (LCP-tac), everolimus, and prednisone vs LCP-tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post-transplant, patients were randomized to receive LCP-tac and everolimus once daily or LCP-tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well-tolerated, and medication side effect burden tended to be less severe in the intervention group. Self-reported high medication adherence decreased in the control arm from baseline to 6 months (80%-59%), while remaining the same in the intervention arm throughout the study (45%-47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once-daily immunosuppression regimen. The impact of this once-daily regimen on medication adherence requires a larger long-term study.

Costs and factors associated with heart failure following kidney transplantation - a single-center retrospective cohort study.

The number of adults with heart failure (HF) will increase by ~50% between 2012 and 2030. Among kidney transplant recipients, HF accounts for 16% of all post-transplant admissions. We describe the burden of HF and predictors of healthcare utilization following kidney transplantation. We retrospectively identified adults who underwent kidney transplantation at our institution (01/2007-12/2017). Data were acquired from electronic health records, with healthcare utilization obtained from a statewide database. The HF incidence rate and prevalence were estimated for each year, total charges for HF and non-HF patients were compared, and logistic regression was employed for a 3-year predictive model of healthcare utilization associated with HF. Among 1731 kidney transplant recipients, the post-transplant HF incidence rate ranged from 1.91 (year 3) to 6.80 (year 10) per 100 person-years, while the prevalence increased from 31.7% (year 1) to 48.1% (year 10). Median charges were $75 837 (HF) compared to $42 940 (non-HF) per person-year (P < 0.001). Pretransplant HF [odds ratio (OR) = 3.12] and an eGFR < 45 (OR = 4.73) were the strongest predictors of HF encounters (P < 0.05 for both). We observed a high and increasing prevalence of HF, which was associated with twice the costs. Kidney transplant recipients would benefit from interventions aimed at mitigating HF risk factors.

Randomized controlled trial assessing the impact of everolimus and low-exposure tacrolimus on graft outcomes in kidney transplant recipients.

This was a single-center, randomized controlled trial assessing the impact of a 3-month (10-16 weeks) conversion to everolimus with low-exposure tacrolimus, as compared to remaining on full exposure tacrolimus with mycophenolate (NCT02096107). Adult kidney transplant recipients with a functioning graft were eligible for participation. Goal troughs in the intervention arm were 2-5 ng/mL for tacrolimus and 3-8 ng/mL for everolimus, with tacrolimus maintained at 5-12 ng/mL in the control arm; 60 were randomized (30 in each arm) and were well matched at baseline; mean age was 51 years and 57% were African-American. At 12-months, fibrosis scores (27.8% tacrolimus/mycophenolate vs 22.9% tacrolimus/everolimus, P = .391), acute rejection rates (7% tacrolimus/mycophenolate vs 3% tacrolimus/everolimus, P = .554), and graft function (mean eGFR tacrolimus/mycophenolate 56 ± 15 vs tacrolimus/everolimus 59 ± 14 mL/min/1.73 m2 , P = .465) were similar between arms. The everolimus arm had significantly lower rates of CMV infection, severe BK infection, and improved BK viral clearance kinetics, as compared to the MPA arm. In this population, including a significant number of African-Americans, an immunosuppression regimen of everolimus with low-exposure tacrolimus provided similar efficacy to tacrolimus and mycophenolate, with significantly lower rates of BK and CMV.

Hospital admissions and emergency department visits among kidney transplant recipients.

Reducing acute care utilization is a means of improving long-term patient outcomes. We sought to assess high inpatient (IP) admission and standalone emergency department (ED) utilization within a 9-month period post-kidney transplantation and to identify mutable factors to reduce utilization. In this ten-year retrospective study, 1599 adult kidney transplant recipients were identified. A previous transplant, graft loss, or death within 3 months post-transplantation excluded 319 patients. Comprehensive resource utilization data were obtained from a statewide database. Those with ≥2 IP admissions or standalone ED visits 4-12 months post-transplantation were classified as high utilizers. Multivariable logistic regression models were used for examining associations of predictors with high IP or ED utilization. Of 1280 kidney recipients, 209 and 183 were categorized as IP and ED high utilizers, respectively. Factors significantly associated with high IP utilization included valvular disease, body mass index ≥35, and IP or ED use <3 months post-transplantation; while factors associated with high ED utilization included IP or ED use <3 months post-transplantation, younger age, female, smoker, congestive heart failure, depression, and IP or ED use 1 year pre-transplantation. Inpatient and standalone ED utilization within a 9-month period after kidney transplantation is high and associated with sociodemographic factors, mutable comorbidities, and healthcare utilization.

The impact of time-varying clinical surrogates on disparities in African-American kidney transplant recipients - a retrospective longitudinal cohort study.

An improved understanding of the impact of clinical surrogates on disparities in African-American (AA) kidney transplantation (KTX) is needed. We conducted a 10-year retrospective longitudinal cohort study of electronically abstracted clinical data assessing the impact of surrogates on disparities in KTX. Clinical surrogates were assessed by posttransplant year (1, 2, 3 or 4) and defined as acute rejection (Banff ≥1A), mean SBP >140 mmHg, tacrolimus variability (CV) >40%, mean glucose >160 mg/dl and mean hemoglobin <10 g/dl. We utilized landmark methodology to minimize immortal time bias and logistic and survival regression to assess outcomes; 1610 KTX were assessed (54.2% AAs), with 1000, 468, 368 and 303 included in the year 1, 2, 3 and 4 complete case analyses, respectively. AAs had significantly higher odds of developing a clinical surrogate, which increased in posttransplant years three and four [OR year 1 1.99 (1.38-2.88), year 2 1.77 (1.20-2.62), year 3 2.35 (1.49-3.71), year 4 2.85 (1.72-4.70)]. Adjusting for the five clinical surrogates in survival models explained a significant portion of the higher risks of graft loss in AAs in post-transplant years three and four. Results suggest focusing efforts on improving late clinical surrogate management within AAs may help mitigate racial disparities in KTX.

Development and future deployment of a 5 years allograft survival model for kidney transplantation.

AIM: Identifying kidney transplant patients at highest risk for graft loss prior to loss may allow for effective interventions to improve 5 years survival. METHODS: We performed a 10 years retrospective cohort study of adult kidney transplant recipients (n = 1747). We acquired data from electronic health records, United Network of Organ Sharing, social determinants of health, natural language processing data extraction, and real-time capture of dynamically evolving clinical data obtained within 1 year of transplant; from which we developed a 5 years graft survival model. RESULTS: Total of 1439 met eligibility; 265 (18.4%) of them experienced graft loss by 5 years. Graft loss patients were characterized by: older age, being African-American, diabetic, unemployed, smokers, having marginal donor kidneys and cardiovascular comorbidities. Predictive dynamic variables included: low mean blood pressure, higher pulse pressures, higher heart rate, anaemia, lower estimated glomerular filtration rate peak, increased tacrolimus variability, rejection and readmissions. This Big Data analysis generated a 5 years graft loss model with an 82% predictive capacity, versus 66% using baseline United Network of Organ Sharing data alone. CONCLUSION: Our analysis yielded a 5 years graft loss model demonstrating superior predictive capacity compared with United Network of Organ Sharing data alone, allowing post-transplant individualized risk-assessed care prior to transitioning back to community care.

Renal Function Variability: An Independent Risk Factor for Graft Loss and Death following Kidney Transplantation.

BACKGROUND: Several studies have been performed to evaluate surrogate markers of long-term allograft function in renal transplant recipients. These include serum creatinine, estimated glomerular filtration rate (eGFR), slope of eGFR, and more recently eGFR variability. The aim of this study was to measure eGFR slope while assessing the variability of this slope and if high variability occurring at any time post-transplant was predictive of poorer long-term outcomes in a large cohort of kidney transplant recipients. METHODS: Adult solitary kidney transplant recipients transplanted between July 1, 2005 and July 31, 2015 were included. The primary outcome was time to graft loss, defined as return to chronic dialysis, retransplant, or death. Secondary outcomes were death-censored graft loss and acute allograft rejection. Cox regression was utilized for primary and secondary outcomes. Multivariate logistic regression was used to determine baseline factors predictive of high eGFR variability. RESULTS: A total of 1,543 patients were included in the analysis. The percentage of patients who experienced an eGFR coefficient of variation of <30% was 79.6% (1,229/1,543), while 20.4% (314/1,543) patients had high eGFR variability (≥30%). Patients with high eGFR variability tended to be younger, African-American and female. Those with higher eGFR variability, accounting for confounding and other eGFR measures (peak and slope), had significantly lower overall patient and graft survival. CONCLUSION: This study provides a novel analysis of the utility of eGFR variability in a large cohort. The clinical use of the slope of eGFR and eGFR variability may aid in predicting long-term graft outcomes and facilitate early patient discussions to change the trajectory of allograft function.

A quantitative appraisal of African Americans' decisions to become registered organ donors at the driver's license office.

African American (AA) organ donation registration rates fall short of national objectives. The goal of the present study was to utilize data acquired from a quantitative telephone survey to provide information for a future Department of Motorized Vehicles (DMV) intervention to increase AA organ donor registration at the DMV. AAs (n = 20 177) that had visited an Alabama DMV office within a 3-month period were recruited via direct mailing to participate in a quantitative phone survey. Data from 155 respondents that participated in the survey were analyzed. Of those respondents deciding to become a registered organ donor (ROD; n = 122), one-third made that decision at the time of visiting the DMV. Of those who chose not to become a ROD (n = 33), one-third made the decision during the DMV visit. Almost 85% of all participants wanted to learn more about organ donation while waiting at the DMV, preferably via TV messaging (digital signage), with the messaging delivered from organ donors, transplant recipients, and healthcare experts. Altruism, accurate organ donation information, and encouragement from family and friends were the most important educational topics to support AAs becoming a ROD. These data provide a platform to inform future interventions designed to increase AAs becoming a ROD at the DMV.

When Should ED Physicians Use an HIE? Predicting Presence of Patient Data in an HIE.

OBJECTIVES: Health information exchanges (HIEs) make possible the construction of databases to characterize patients as multisystem users (MSUs), those visiting emergency departments (EDs) of more than one hospital system within a region during a 1-year period. HIE data can inform an algorithm highlighting patients for whom information is more likely to be present in the HIE, leading to a higher yield HIE experience for ED clinicians and incentivizing their adoption of HIE. Our objective was to describe patient characteristics that determine which ED patients are likely to be MSUs and therefore have information in an HIE, thereby improving the efficacy of HIE use and increasing ED clinician perception of HIE benefit. METHODS: Data were extracted from a regional HIE involving four hospital systems (11 EDs) in the Charleston, South Carolina area. We used univariate and multivariable regression analyses to develop a predictive model for MSU status. RESULTS: Factors associated with MSUs included younger age groups, dual-payer insurance status, living in counties that are more rural, and one of at least six specific diagnoses: mental disorders; symptoms, signs, and ill-defined conditions; complications of pregnancy, childbirth, and puerperium; diseases of the musculoskeletal system; injury and poisoning; and diseases of the blood and blood-forming organs. For patients with multiple ED visits during 1 year, 43.8% of MSUs had ≥4 visits, compared with 18.0% of non-MSUs (P < 0.0001). CONCLUSIONS: This predictive model accurately identified patients cared for at multiple hospital systems and can be used to increase the likelihood that time spent logging on to the HIE will be a value-added effort for emergency physicians.

A Comprehensive View of Frequent Emergency Department Users Based on Data from a Regional HIE.

OBJECTIVES: A small but significant number of patients make frequent emergency department (ED) visits to multiple EDs within a region. We have a unique health information exchange (HIE) that includes every ED encounter in all hospital systems in our region. Using our HIE we were able to characterize all frequent ED users in our region, regardless of hospital visited or payer class. The objective of our study was to use data from an HIE to characterize patients in a region who are frequent ED users (FEDUs). METHODS: We constructed a database from a cohort of adult patients (18 years old or older) with information in a regional HIE for a 1-year period beginning in April 2012. Patients were defined as FEDUs (those who made four or more visits during the study period) and non-FEDUs (those who made fewer than four ED visits during the study period). Predictor variables included age, race, sex, payer class, county of residence, and International Classification of Diseases, Ninth Revision codes. Bivariate (χ(2)) and multivariate (logistic regression) analyses were performed to determine associations between predictor variables and the outcome of being a FEDU. RESULTS: The database contained 127,672 patients, 12,293 (9.6%) of whom were FEDUs. Logistic regression showed the following patient characteristics to be significantly associated with the outcome of being a FEDU: age 35 to 44 years; African American race; Medicaid, Medicare, and dual-pay payer class; and International Classification of Diseases, Ninth Revision codes 630 to 679 (complications of pregnancy, childbirth, and puerperium), 780 to 799 (ill-defined conditions), 280 to 289 (diseases of the blood), 290-319 (mental disorders), 680 to 709 (diseases of the skin and subcutaneous tissue), 710 to 739 (musculoskeletal and connective tissue disease), 460 to 519 (respiratory disease), and 520 to 579 (digestive disease). No significant differences were noted between men and women. CONCLUSIONS: Data from an HIE can be used to describe all of the patients within a region who are FEDUs, regardless of the hospital system they visited. This information can be used to focus care coordination efforts and link appropriate patients to a medical home. Future studies can be designed to learn the reasons why patients become FEDUs, and interventions can be developed to address deficiencies in health care that result in frequent ED visits.

Multilevel Intervention to Improve Racial Equity in Access to Kidney Transplant.

BACKGROUND: African Americans (AAs) have reduced access to kidney transplant (KTX). Our center undertook a multilevel quality improvement endeavor to address KTX access barriers, focused on vulnerable populations. This program included dialysis center patient/staff education, embedding telehealth services across South Carolina, partnering with community providers to facilitate testing/procedures, and increased use of high-risk donors. STUDY DESIGN: This was a time series analysis from 2017 to 2021 using autoregression to assess trends in equitable access to KTX for AAs. Equity was measured using a modified version of the Kidney Transplant Equity Index (KTEI), defined as the proportion of AAs in South Carolina with end-stage kidney disease (ESKD) vs the proportion of AAs initiating evaluation, completing evaluation, waitlisting, and undergoing KTX. A KTEI of 1.00 is considered complete equity; a KTEI of <1.00 is indicative of disparity. RESULTS: From January 2017 to September 2021, 11,487 ESKD patients (64.7% AA) were referred, 6,748 initiated an evaluation (62.8% AA), 4,109 completed evaluation (59.7% AA), 2,762 were waitlisted (60.0% AA), and 1,229 underwent KTX (55.3% AA). The KTEI for KTX demonstrated significant improvements in equity. The KTEI for initiated evaluations was 0.89 in 2017, improving to 1.00 in 2021 (p = 0.0045). Completed evaluation KTEI improved from 0.85 to 0.95 (p = 0.0230), while waitlist addition KTEI improved from 0.83 to 0.96 (p = 0.0072). The KTEI for KTX also improved from 0.76 to 0.91, which did not reach statistical significance (p = 0.0657). CONCLUSIONS: A multilevel intervention focused on improving access to vulnerable populations was significantly associated with reduced disparities for AAs.

A Dialysis Center Educational Video Intervention Increases Patient Self-Efficacy and Kidney Transplant Evaluations.

Introduction: The optimal treatment for end-stage kidney disease is renal transplant. However, only 1 in 5 (21.5%) patients nationwide receiving dialysis are on a transplant waitlist. Factors associated with patients not initiating a transplant evaluation are complex and include patient specific factors such as transplant knowledge and self-efficacy. Research Question: Can a dialysis center-based educational video intervention increase dialysis patients' transplant knowledge, self-efficacy, and transplant evaluations initiated? Design: Dialysis patients who had not yet completed a transplant evaluation were provided a transplant educational video while receiving hemodialysis. Patients' transplant knowledge, self-efficacy to initiate an evaluation, and dialysis center rates of transplant referral and evaluation were assessed before and after this intervention. Results: Of 340 patients approached at 14 centers, 252 (74%) completed the intervention. The intervention increased transplant knowledge (Likert scale 1 to 5: 2.53 [0.10] vs 4.62 [0.05], P < .001) and transplant self-efficacy (2.55 [0.10] to 4.33 [0.07], P < .001. The incidence rate per 100 patient years of transplant evaluations increased 85% (IRR 1.85 [95% CI: 1.02, 3.35], P = .0422) following the intervention. The incidence rates of referrals also increased 56% (IRR 1.56 [95% CI: 1.03, 2.37], P = .0352), while there was a nonsignificant 47% increase in incidence rates of waitlist entries (IRR 1.47 [95% CI: 0.45, 4.74], P = .5210). Conclusion: This dialysis center-based video intervention provides promising preliminary evidence to conduct a large-scale randomized controlled trial to test its effectiveness in increasing self-efficacy of dialysis patients to initiate a transplant evaluation.

Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial.

PURPOSE: Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies. METHODS: This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care. RESULTS: Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time. CONCLUSION: This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.

Association of High Burden of End-stage Kidney Disease With Decreased Kidney Transplant Rates With the Updated US Kidney Allocation Policy.

Importance: The Organ Procurement and Transplantation Network (OPTN) approved changes to the US kidney allocation system in 2019. The potential effects of this policy change using transplant rates normalized to end-stage kidney disease (ESKD) incidence have not been investigated. Objective: To estimate how the OPTN kidney allocation policy will affect areas of the US currently demonstrating low rates of kidney transplant, when accounting for the regional burden of ESKD. Design, Setting, and Participants: This cross-sectional population-based economic evaluation analyzed access of patients with ESKD to kidney transplant in the US. Participants included patients with incident ESKD, those on the kidney transplant wait list, and those who received a kidney transplant. Data were collected from January 1 to December 31, 2017, and were analyzed in 2019. Main Outcomes and Measures: The probability of a patient with ESKD being placed on the transplant wait list or receiving a deceased donor kidney transplant. States and donor service areas (DSAs) were compared for gains and losses in rates of transplanted kidneys under the new allocation system. Transplant rates were normalized for ESKD burden. Results: A total of 122 659 patients had incident ESKD in the US in 2017 (58.2% men; mean [SD] age, 62.8 [15.1] years). The probability of a patient with ESKD receiving a deceased donor kidney transplant varied 3-fold across the US (from 6.36% in West Virginia to 18.68% in the District of Columbia). Modeling of the OPTN demonstrates that DSAs from New York (124%), Georgia (65%), and Illinois (56%) are estimated to experience the largest increases in deceased donor kidney allocation. Other than Georgia, these states have kidney transplant rates per incident ESKD cases above the mean (of 50 states plus the District of Columbia, New York is 16th and Illinois is 24th). In contrast, DSAs from Nevada (-74%), Ohio (-67%), and North Carolina (-61%)-each of which has a transplant rate per incident ESKD cases significantly below the mean-are estimated to experience the largest decreases in deceased donor allocation (of 50 states plus the District of Columbia, North Carolina is 34th, Ohio is 38th, and Nevada is 47th). Conclusions and Relevance: The new OPTN-approved kidney allocation policy may result in worsening geographic disparities in access to transplants when measured against the burden of ESKD within a particular region of the US.