Effect of Intensive Blood Pressure Control on Kidney Outcomes: Long-Term Electronic Health Record-Based Post-Trial Follow-Up of SPRINT.

BACKGROUND: Intensive BP lowering in the Systolic Blood Pressure Intervention Trial (SPRINT) produced acute decreases in kidney function and higher risk for AKI. We evaluated the effect of intensive BP lowering on long-term changes in kidney function using trial and outpatient electronic health record (EHR) creatinine values. METHODS: SPRINT data were linked with EHR data from 49 (of 102) study sites. The primary outcome was the total slope of decline in eGFR for the intervention phase and the post-trial slope of decline during the observation phase using trial and outpatient EHR values. Secondary outcomes included a ≥30% decline in eGFR to <60 ml/min per 1.73 m 2 and a ≥50% decline in eGFR or kidney failure among participants with baseline eGFR ≥60 and <60 ml/min per 1.73 m 2 , respectively. RESULTS: EHR creatinine values were available for a median of 8.3 years for 3041 participants. The total slope of decline in eGFR during the intervention phase was -0.67 ml/min per 1.73 m 2 per year (95% confidence interval [CI], -0.79 to -0.56) in the standard treatment group and -0.96 ml/min per 1.73 m 2 per year (95% CI, -1.08 to -0.85) in the intensive treatment group ( P < 0.001). The slopes were not significantly different during the observation phase: -1.02 ml/min per 1.73 m 2 per year (95% CI, -1.24 to -0.81) in the standard group and -0.85 ml/min per 1.73 m 2 per year (95% CI, -1.07 to -0.64) in the intensive group. Among participants without CKD at baseline, intensive treatment was associated with higher risk of a ≥30% decline in eGFR during the intervention (hazard ratio, 3.27; 95% CI, 2.43 to 4.40), but not during the postintervention observation phase. In those with CKD at baseline, intensive treatment was associated with a higher hazard of eGFR decline only during the intervention phase (hazard ratio, 1.95; 95% CI, 1.03 to 3.70). CONCLUSIONS: Intensive BP lowering was associated with a steeper total slope of decline in eGFR and higher risk for kidney events during the intervention phase of the trial, but not during the postintervention observation phase.

Concordance between clinical outcomes in the Systolic Blood Pressure Intervention Trial and in the electronic health record.

BACKGROUND: Randomized trials are the gold standard for generating clinical practice evidence, but follow-up and outcome ascertainment are resource-intensive. Electronic health record (EHR) data from routine care can be a cost-effective means of follow-up, but concordance with trial-ascertained outcomes is less well-studied. METHODS: We linked EHR and trial data for participants of the Systolic Blood Pressure Intervention Trial (SPRINT), a randomized trial comparing intensive and standard blood pressure targets. Among participants with available EHR data concurrent to trial-ascertained outcomes, we calculated sensitivity, specificity, positive predictive value, and negative predictive value for EHR-recorded cardiovascular disease (CVD) events, using the gold standard of SPRINT-adjudicated outcomes (myocardial infarction (MI)/acute coronary syndrome (ACS), heart failure, stroke, and composite CVD events). We additionally compared the incidence of non-CVD adverse events (hyponatremia, hypernatremia, hypokalemia, hyperkalemia, bradycardia, and hypotension) in trial versus EHR data. RESULTS: 2468 SPRINT participants were included (mean age 68 (SD 9) years; 26% female). EHR data demonstrated ≥80% sensitivity and specificity, and ≥ 99% negative predictive value for MI/ACS, heart failure, stroke, and composite CVD events. Positive predictive value ranged from 26% (95% CI; 16%, 38%) for heart failure to 52% (95% CI; 37%, 67%) for MI/ACS. EHR data uniformly identified more non-CVD adverse events and higher incidence rates compared with trial ascertainment. CONCLUSIONS: These results support a role for EHR data collection in clinical trials, particularly for capturing laboratory-based adverse events. EHR data may be an efficient source for CVD outcome ascertainment, though there is clear benefit from adjudication to avoid false positives.

One-year all-cause mortality in hospitalized patients with COVID-19 and end-stage renal disease undergoing hemodialysis.

INTRODUCTION: Patients with end-stage renal disease (ESRD) on dialysis and COVID-19 infection have an increased risk of in-hospital mortality, but whether these patients have a higher long-term mortality risk is unknown. MATERIALS AND METHODS: Retrospective chart review of 958 patients admitted with COVID-19 infection or those with ESRD admitted for any other reason between February 2020 and August 2020. We collected data on demographics, comorbidities, laboratory tests, and mortality. The primary outcome was all-cause 1-year mortality. The secondary outcome was in-hospital mortality. We used primarily logistic regression models to assess the mortality risk. RESULTS: In total, 651 patients without ESRD with COVID-19 (COVID+ESRD-), 259 with ESRD without COVID-19 (ESRD+COVID-), and 48 with ESRD with COVID-19 (COVID+ESRD+) were hospitalized between February 2020 and August 2020. Patients were followed after discharge until September 2021. The all-cause 1-year mortality rates were 24% in patients with COVID+ESRD-, 22% in ESRD+COVID- patients, and 40% in those with COVID+ESRD+ (p < 0.05). Compared to the COVID+ESRD- group, the unadjusted and adjusted odds ratio (OR) for all-cause 1-year mortality in the COVID+ESRD+ group was 2.13 (95% confidence interval (CI), 1.16 - 3.91) and 2.15 (95% CI,1.12 - 4.14), respectively. The unadjusted and adjusted OR for all-cause in-hospital mortality in the COVID+ESRD+ group was 1.79 (95% CI, 0.92 - 3.49); and 1.79 (95% CI, 0.88 - 3.65), respectively. We found no statistically significant difference between the COVID+ESRD- and ESRD+COVID- groups for both in-hospital and 1-year mortality (p > 0.05). CONCLUSION: Patients with COVID+ESRD+ have significantly higher odds for all-cause 1-year mortality compared to COVID+ESRD- patients. Future studies should investigate the mechanisms of long-term mortality risk in ESRD patients with COVID-19 infection.

Correlative analysis of wastewater trends with clinical cases and hospitalizations through five dominant variant waves of COVID-19.

Wastewater-based epidemiology (WBE) has been utilized to track community infections of Coronavirus Disease 2019 (COVID-19) by detecting RNA of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), within samples collected from wastewater. The correlations between community infections and wastewater measurements of the RNA can potentially change as SARS-CoV-2 evolves into new variations by mutating. This study analyzed SARS-CoV-2 RNA, and indicators of human waste in wastewater from two sewersheds of different scales (University of Miami (UM) campus and Miami-Dade County Central District wastewater treatment plant (CDWWTP)) during five internally defined COVID-19 variant dominant periods (Initial, Pre-Delta, Delta, Omicron and Post-Omicron wave). SARS-CoV-2 RNA quantities were compared against COVID-19 clinical cases and hospitalizations to evaluate correlations with wastewater SARS-CoV-2 RNA. Although correlations between documented clinical cases and hospitalizations were high, prevalence for a given wastewater SARS-CoV-2 level varied depending upon the variant analyzed. The correlative relationship was significantly steeper (more cases per level found in wastewater) for the Omicron-dominated period. For hospitalization, the relationships were steepest for the Initial wave, followed by the Delta wave with flatter slopes during all other waves. Overall results were interpreted in the context of SARS-CoV-2 virulence and vaccination rates among the community.

Effect of Intensive versus Standard BP Control on AKI and Subsequent Cardiovascular Outcomes and Mortality: Findings from the SPRINT EHR Study.

Background: Adjudication of inpatient AKI in the Systolic Blood Pressure Intervention Trial (SPRINT) was based on billing codes and admission and discharge notes. The purpose of this study was to evaluate the effect of intensive versus standard BP control on creatinine-based inpatient and outpatient AKI, and whether AKI was associated with cardiovascular disease (CVD) and mortality. Methods: We linked electronic health record (EHR) data from 47 clinic sites with trial data to enable creatinine-based adjudication of AKI. Cox regression was used to evaluate the effect of intensive BP control on the incidence of AKI, and the relationship between incident AKI and CVD and all-cause mortality. Results: A total of 3644 participants had linked EHR data. A greater number of inpatient AKI events were identified using EHR data (187 on intensive versus 155 on standard treatment) as compared with serious adverse event (SAE) adjudication in the trial (95 on intensive versus 61 on standard treatment). Intensive treatment increased risk for SPRINT-adjudicated inpatient AKI (HR, 1.51; 95% CI, 1.09 to 2.08) and for creatinine-based outpatient AKI (HR, 1.40; 95% CI, 1.15 to 1.70), but not for creatinine-based inpatient AKI (HR, 1.20; 95% CI, 0.97 to 1.48). Irrespective of the definition (SAE or creatinine based), AKI was associated with increased risk for all-cause mortality, but only creatinine-based inpatient AKI was associated with increased risk for CVD. Conclusions: Creatinine-based ascertainment of AKI, enabled by EHR data, may be more sensitive and less biased than traditional SAE adjudication. Identifying ways to prevent AKI may reduce mortality further in the setting of intensive BP control.

Automation of mass vaccination against COVID-19 at an academic health center.

As vaccines against COVID-19 became available for distribution, the University of Miami addressed several challenges to facilitate vaccine allocation to the highest risk employees, patients, and students. Advanced use of technology allowed for the automation of key processes in the mass vaccination effort, which expedited vaccine outreach and scheduling, while maintaining routine delivery of healthcare services. The University's employees were initially prioritized for vaccination; employees who opted in were stratified into 5 vaccine administration phases. A similar process was implemented for students. When the state of Florida mandated expansion of vaccine allocation to include individuals aged 65 and older, an algorithm for patients was designed, taking into account age, comorbidities, date of last visit, and presence of an activated patient portal account. Innovative use of technology allowed for 19  000 vaccines to be administered within the first 37 days, which comprised 100% vaccine allotment, without wasting a single vaccine dose.

Factors to Effective Telemedicine Visits During the COVID-19 Pandemic: Cohort Study.

BACKGROUND: With COVID-19 there was a rapid and abrupt rise in telemedicine implementation often without sufficient time for providers or patients to adapt. As telemedicine visits are likely to continue to play an important role in health care, it is crucial to strive for a better understanding of how to ensure completed telemedicine visits in our health system. Awareness of these barriers to effective telemedicine visits is necessary for a proactive approach to addressing issues. OBJECTIVE: The objective of this study was to identify variables that may affect telemedicine visit completion in order to determine actions that can be enacted across the entire health system to benefit all patients. METHODS: Data were collected from scheduled telemedicine visits (n=362,764) at the University of Miami Health System (UHealth) between March 1, 2020 and October 31, 2020. Descriptive statistics, mixed effects logistic regression, and random forest modeling were used to identify the most important patient-agnostic predictors of telemedicine completion. RESULTS: Using descriptive statistics, struggling telemedicine specialties, providers, and clinic locations were identified. Through mixed effects logistic regression (adjusting for clustering at the clinic site level), the most important predictors of completion included previsit phone call/SMS text message reminder status (confirmed vs not answered) (odds ratio [OR] 6.599, 95% CI 6.483-6.717), MyUHealthChart patient portal status (not activated vs activated) (OR 0.315, 95% CI 0.305-0.325), provider's specialty (primary care vs medical specialty) (OR 1.514, 95% CI 1.472-1.558), new to the UHealth system (yes vs no) (OR 1.285, 95% CI 1.201-1.374), and new to provider (yes vs no) (OR 0.875, 95% CI 0.859-0.891). Random forest modeling results mirrored those from logistic regression. CONCLUSIONS: The highest association with a completed telemedicine visit was the previsit appointment confirmation by the patient via phone call/SMS text message. An active patient portal account was the second strongest variable associated with completion, which underscored the importance of patients having set up their portal account before the telemedicine visit. Provider's specialty was the third strongest patient-agnostic characteristic associated with telemedicine completion rate. Telemedicine will likely continue to have an integral role in health care, and these results should be used as an important guide to improvement efforts. As a first step toward increasing completion rates, health care systems should focus on improvement of patient portal usage and use of previsit reminders. Optimization and intervention are necessary for those that are struggling with implementing telemedicine. We advise setting up a standardized workflow for staff.

Demographics associated with US healthcare disparities are exacerbated by the telemedicine surge during the COVID-19 pandemic.

INTRODUCTION: As coronavirus disease 2019 (COVID-19) hit the US, there was widespread and urgent implementation of telemedicine programs nationwide without much focus on the impact on patient populations with known existing healthcare disparities. To better understand which populations cannot access telemedicine during the coronavirus disease 2019 pandemic, this study aims to demographically describe and identify the most important demographic predictors of telemedicine visit completion in an urban health system. METHODS: Patient de-identified demographics and telemedicine visit data (N = 362,764) between March 1, 2020 and October 31, 2020 were combined with Internal Revenue Service 2018 individual income tax data by postal code. Descriptive statistics and mixed effects logistic regression were used to determine impactful patient predictors of telemedicine completion, while adjusting for clustering at the clinical site level. RESULTS: Many patient-specific demographics were found to be significant. Descriptive statistics showed older patients had lower rates of completion (p < 0.001). Also, Hispanic patients had statistically significant lower rates (p < 0.001). Overall, minorities (racial, ethnic, and language) had decreased odds ratios of successful telemedicine completion compared to the reference. DISCUSSION: While telemedicine use continues to be critical during the coronavirus disease 2019 pandemic, entire populations struggle with access-possibly widening existing disparities. These results contribute large datasets with significant findings to the limited research on telemedicine access and can help guide us in improving telemedicine disparities across our health systems and on a wider scale.

Social determinants of health score: does it help identify those at higher cardiovascular risk?

OBJECTIVES: Cardiovascular disease (CVD) continues to disproportionately affect disadvantaged populations, leading to calls to address social determinants of health (SDOH) as a preventive strategy. Our aim is to create a weighed SDOH score and to test the impact of each SDOH factor on the Framingham risk score (FRS) and on individual traditional CVD risk factors. STUDY DESIGN: We conducted a retrospective cohort study. METHODS: We included patients seen at a primary care clinic at UHealth/University of Miami Health System who answered a SDOH survey between September 16, 2016, and September 10, 2017. The survey included SDOH domains recommended by the American Heart Association position statement and by the National Academy of Medicine. We selected the FRS as well as all traditional CVD risk factors as our outcome metrics. RESULTS: We included 2876 patients. The mean (SD) age of our cohort was 53.8 (15.8) years, 61% were female, 9% were Black, 38% were Hispanic, and 87% reported speaking English. The statistically significant ß coefficients in the FRS model corresponded to being born outside of the United States, being a racial minority, living alone, having a high social isolation score, and having a low geocoded median household income (P < .01). Increasing quartile of SDOH score was significantly associated with higher systolic blood pressure, FRS, glycated hemoglobin, and smoking pack-years (P < .05). It was also associated with fewer minutes spent exercising weekly (P < .01). CONCLUSIONS: The addition of self-reported SDOH data has a dose effect on CVD risk factors. Future studies should address how to intervene to address social factors.

A How-to Guide to Building a Robust SARS-CoV-2 Testing Program at a University-Based Health System.

When South Florida became a hot spot for COVID-19 disease in March 2020, we faced an urgent need to develop test capability to detect SARS-CoV-2 infection. We assembled a transdisciplinary team of knowledgeable and dedicated physicians, scientists, technologists, and administrators who rapidly built a multiplatform, polymerase chain reaction- and serology-based detection program, established drive-through facilities, and drafted and implemented guidelines that enabled efficient testing of our patients and employees. This process was extremely complex, due to the limited availability of needed reagents, but outreach to our research scientists and multiple diagnostic laboratory companies, and government officials enabled us to implement both Food and Drug Administration authorized and laboratory-developed testing-based testing protocols. We analyzed our workforce needs and created teams of appropriately skilled and certified workers to safely process patient samples and conduct SARS-CoV-2 testing and contact tracing. We initiated smart test ordering, interfaced all testing platforms with our electronic medical record, and went from zero testing capacity to testing hundreds of health care workers and patients daily, within 3 weeks. We believe our experience can inform the efforts of others when faced with a crisis situation.

A Novel Interdisciplinary Iterative Approach for Optimizing the Electronic Health Record to Improve Perioperative Efficiency.

OBJECTIVE: We present a holistic perioperative optimization approach led by a CI team with the goal to optimize the workflow within our EHR, improve operative room metrics and user satisfaction. SUMMARY OF BACKGROUND DATA: The EHR has become integral to perioperative care. Many approaches are utilized to improve performance including systems-based approaches, process redesign, lean methodology, checklists, root cause analysis, and parallel processing. Although most reports describe strategies improving day or surgery productivity, few include perioperative interventions to improve efficiencies. METHODS: An interdisciplinary CI team consisting of clinicians, informatics specialists, and analysts spent 6 weeks assessing users and optimizing all perioperative areas (scheduling, day of surgery, postop discharge/admission). Elbow-to-elbow retraining and simultaneous content development was performed utilizing an Agile workflow process optimization with the Scrum framework. This iterative approach averaged 1 week from build to change implementation. Pre/post optimization surveys were sent. RESULTS: Two hundred forty-two perioperative enhancements were completed. While most impacted documentation, all areas were enhanced including billing, reporting, registration, device integration, scheduling, central supply, and so on. FCOTS improved from <70% to >85% and total delay was halved. These parameters were consistently sustained for over 1 year after the 6-week optimization. While only 5% of pre-optimization users agreed to proficiency in the EHR system, this improved to 70% post-optimization. Furthermore, EHR confidence and acceptance improved from 40% to 90%. CONCLUSIONS: To improve workflow efficiency, all who contribute to the perioperative process must be assessed. This IT driven initiative resulted in improved FCOTS, perioperative workflows, and user satisfaction.

Modifying Effect of Statins on Fatal Outcomes in Chronic Kidney Disease Patients in the Systolic Blood Pressure Intervention Trial: A Post Hoc Analysis.

BACKGROUND: Management of chronic kidney disease (CKD) patients includes efforts directed toward modifying traditional cardiovascular risk factors. Such efforts include optimal management of hypertension together with the initiation of statin therapy. METHODS: In this observational study, we determine the modifying effect of statins on the relationship of systolic blood pressure (SBP) goal with mortality and other outcomes in patients with CKD participating in a clinical trial. At baseline, 2,646 CKD patients (estimated glomerular filtration rate < 60 mL/min/1.73 m2) were randomized to an intensive SBP goal < 120 mm Hg or standard SBP goal <140 mm Hg. One thousand two hundred and seventy-three were not on statin, 1,354 were on a statin, and in 19 the use of statin was unknown. The 2 primary outcomes were all-cause mortality and cardiovascular disease (CVD) mortality. RESULTS: The relationships of SBP goal with all-cause mortality (interaction p = 0.009) and cardiovascular (CV) mortality (interaction p = 0.021) were modified by the use of statin after adjusting for age, gender, race, CVD history, smoking, aspirin use, and blood pressure at baseline. In the statin group, targeting SBP to < 120 mm Hg compared to SBP < 140 mm Hg significantly reduced the risk of all-cause mortality (adjusted hazard ratio [aHR] 0.44 [0.28-0.71]; event rates 1.16 vs. 2.5 per 100 patient-years) and CV mortality (aHR 0.29 [0.12-0.74]; event rates 0.28 vs. 0.92 per 100 patient-years) after a median follow-up of 3.26 years. In the non-statin group, the risk of all-cause mortality (aHR 1.07 [0.69-1.66]; event rates 2.01 vs. 1.94 per 100 patient-years) and CV mortality (aHR 1.42 [0.56-3.59]; event rates 0.52 vs. 0.41 per 100 patient-years) were not significantly different in both SBP goal arms. CONCLUSION: The combination of statin therapy and intensive SBP management leads to improved survival in hypertensive patients with CKD.

Provider Perspectives on the Collection of Social Determinants of Health.

Social determinants of health (SDH) impact health outcomes. Medical centers have begun to collect SDH data, urged by government and scientific entities. Provider perspectives on collecting SDH are unknown. The aim is to understand differences in views and preferences according to provider characteristics. A cross-sectional survey of University of Miami clinical faculty was conducted in late 2016. The survey contained 11 questions: 8 demographic and departmental responsibilities questions and 3 Likert scale questions to capture collection and use of SDH perspectives. The main outcome was whether providers thought the benefit of collecting SDH outweighs the burden and risks. In all, 240 faculty members were included. The majority were men (64%), with a mean age of 51 years. Among participants, 53.5% were non-Hispanic white, 32% were Hispanic, 5% were Black/African American, and 5% were Asian. The majority agreed that SDH are important predictors of health outcomes and quality of care (83%). When comparing minority to nonminority faculty, 25% believed that SDH should only be available to PCPs, compared to 8% of nonminorities (P < 0.01). In a multivariate model, belonging to a racial ethnic minority was the only characteristic associated with believing that benefits of collecting SDH outweigh the risks (odds ratio 1.87, 95% confidence interval 1.02- 3.5) after adjusting for age, sex, minority status, health care provider type, type of responsibilities, and department. This study reveals that although most providers of a health system believe social risks impact health outcomes and quality metrics, the buy-in to collect SDH varies according to the racial/ethnic composition of the faculty.

Laparoscopic drainage of lymphocele after kidney transplant.

Lymphocele can develop after renal transplantation. Surgical internal drainage to the abdominal cavity through a standard laparotomy is indicated for symptomatic persistent lesions. Internal drainage can be performed laparoscopically. In this report, we describe our laparoscopic surgical technique for drainage and analyze our results in five patients with lymphoceles that developed after kidney transplantation. All the patients were male, with a mean age of 29 +/- 10 years. The volume of fluid in the lymphoceles ranged from 500 to 1000 mL. Percutaneous drainage was selected as the initial treatment without success. A laparoscopic peritoneal window was created in all patients under intraoperative ultrasonographic guidance. The mean operative time was 90 minutes. In all patients, the fluid collections resolved after laparoscopic internal drainage without complications. During a mean follow-up of 3 +/- 2 years, all patients remained asymptomatic, and no additional fluid collections were identified.