Addressing Physical, Functional, and Physiological Outcomes in Older Adults using an Integrated mHealth Intervention "Active for Life": A Pilot Randomized Controlled Trial.

Objective: We evaluated components of an integrated, mobile health-based intervention "Activate for Life" (AFL) on health outcomes in lower-income older adults (≥ 60 years). Methods: AFL incorporates balance (Otago; OG), physical strength (Gentle Yoga and yogic Breathing; GYYB), and mental engagement (Behavioral Activation; BA) components. Thirty participants were randomly allocated to one of three study arms (n=10): OG (Arm 1), OG+GYYB (Arm 2), or OG+GYYB+BA (Arm 3; a.k.a. "full AFL"). Participants were evaluated for physical, functional, and physiological endpoints at baseline and post-intervention (12-weeks and/or 3-month follow up). Results: Improvements in pain interference and 1,5- anhydroglucitol biomarker levels over time were noted for all arms. No significant changes were observed for other physical, functional, or physiological measures. Discussion: This study illustrates potential benefits of the AFL intervention on the health of lower-income older adults. Lessons learned from this pilot trial will inform design improvements for a large-scale randomized controlled trial.

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.

Advanced liver fibrosis and the metabolic syndrome in a primary care setting.

AIMS: The fibrosis-4 index (FIB-4) and NAFLD fibrosis score (NFS) are noninvasive and accessible methods for assessing advanced liver fibrosis risk in primary care. We evaluated the distribution of FIB-4 and NFS scores in primary care patients with clinical signals for nonalcoholic fatty liver disease (NAFLD). MATERIALS AND METHODS: This retrospective cohort study of electronic record data between 2007 and 2018 included adults with at least one abnormal aminotransferase and no known (non-NAFLD) liver disease. We calculated patient-level FIB-4 and NFS scores, the proportion of patients with mean values exceeding advanced fibrosis thresholds (indeterminate risk: FIB-4 > 1.3, NFS > -1.455; high-risk: FIB-4 > 2.67, NFS > 0.676), and the proportion of patients with a NAFLD International Classification of Diseases-9/10 code. Logistic regression models evaluated the associations of metabolic syndrome (MetS) components with elevated FIB-4 and NFS scores. RESULTS: The cohort included 6506 patients with a median of 6 (interquartile range: 3-13) FIB-4 and NFS scores per patient. Of these patients, 81% had at least two components of MetS, 29% had mean FIB-4 and NFS scores for indeterminate fibrosis risk, and 11% had either mean FIB-4 or NFS scores exceeding the high advanced fibrosis risk thresholds. Regression models identified associations of low high-density lipoprotein, hyperglycemia, Black race and male gender with high-risk FIB-4 and NFS values. Only 5% of patients had existing diagnoses for NAFLD identified. CONCLUSIONS: Many primary care patients have FIB-4 and NFS scores concerning for advanced fibrosis, but rarely a diagnosis of NAFLD. Elevated FIB-4 and NFS scores may provide signals for further clinical evaluation of liver disease in primary care settings.

Remote patient monitoring sustains reductions of hemoglobin A1c in underserved patients to 12 months.

AIMS: We sought to determine whether underserved patients enrolled in a statewide remote patient monitoring (RPM) program for diabetes achieve sustained improvements in hemoglobin A1c at 6 and 12 months and whether those improvements are affected by demographic and clinical variables. METHODS: Demographic and clinical variables were obtained at baseline, 6 months and 12 months. Baseline HbA1c values were compared with those obtained at 6 and 12 months via paired t-tests. A multivariable regression model was developed to identify patient-level variables associated with HbA1c change at 12 months. RESULTS: HbA1c values were obtained for 302 participants at 6 months and 125 participants at 12 months. Compared to baseline, HbA1c values were 1.8% (19 mmol/mol) lower at 6 months (p < 0.01) and 1.3% (14 mmol/mol) lower at 12 months (p < 0.01). Reductions at 12 months were consistent across clinical settings. A regression model for change in HbA1c showed no statistically significant difference for patient age, sex, race, household income, insurance, or clinic type. CONCLUSIONS: Patients enrolled in RPM had improved diabetes control at 6 and 12 months. Neither clinic type nor sociodemographic variables significantly altered the likelihood that patients would benefit from this type of technology. These results suggest the promise of RPM for delivering care to underserved populations.

Linkage to specialty care in the hepatitis C care cascade.

Quality gaps exist in the hepatitis C virus (HCV) care process from diagnosis to cure. To better understand current gaps and to identify targets for quality improvement, we constructed an HCV care cascade in a patient-centered medical home (PCMH) with an emphasis on the specialty referral process. We performed a retrospective study of HCV-infected patients in a PCMH using electronic health record (EPIC) data. Patients with a first positive HCV RNA between 2012 and 2019 were included. With an adaptation to analyze linkage to specialty care, we created an HCV care cascade that included the following: (1) a positive HCV RNA, (2) referral to a specialty provider, (3) a scheduled specialty appointment, (4) attendance at a specialty visit, (5) prescription for HCV therapy, and (6) evidence of sustained virological response (SVR). Patient and referring clinician characteristics were analyzed at each step of the care pathway, and the proportion of patients completing each step was calculated. Of the 256 HCV RNA-positive patients, 229 (89.5%) received a specialty referral; 215 (84.0%) had an appointment scheduled; 178 (69.5%) attended the specialty appointment; 116 (45.3%) were prescribed antiviral therapy; and 87 (34.1%) had documented SVR during the study period. Of the 178 patients attending a specialty visit, 62 (34.8%) did not receive a prescription, and the barrier most often noted was the desire for further workup (40.3%). Gaps occur at all stages of the HCV care continuum, with drop-offs in care occurring both before and after linkage to specialty care.

Geographic and Racial/Ethnic Variation in Glycemic Control and Treatment in a National Sample of Veterans With Diabetes.

OBJECTIVE: Geographic and racial/ethnic disparities related to diabetes control and treatment have not previously been examined at the national level. RESEARCH DESIGN AND METHODS: A retrospective cohort study was conducted in a national cohort of 1,140,634 veterans with diabetes, defined as two or more diabetes ICD-9 codes (250.xx) across inpatient and outpatient records. Main exposures of interest included 125 Veterans Administration Medical Center (VAMC) catchment areas as well as racial/ethnic group. The main outcome measure was HbA1c level dichotomized at ≥8.0% (≥64 mmol/mol). RESULTS: After adjustment for age, sex, racial/ethnic group, service-connected disability, marital status, and the van Walraven Elixhauser comorbidity score, the prevalence of uncontrolled diabetes varied by VAMC catchment area, with values ranging from 19.1% to 29.2%. Moreover, these differences largely persisted after further adjusting for medication use and adherence as well as utilization and access metrics. Racial/ethnic differences in diabetes control were also noted. In our final models, compared with non-Hispanic Whites, non-Hispanic Blacks (odds ratio 1.11 [95% credible interval 1.09-1.14]) and Hispanics (1.36 [1.09-1.14]) had a higher odds of uncontrolled HBA1c level. CONCLUSIONS: In a national cohort of veterans with diabetes, we found geographic as well as racial/ethnic differences in diabetes control rates that were not explained by adjustment for demographics, comorbidity burden, use or type of diabetes medication, health care utilization, access metrics, or medication adherence. Moreover, disparities in suboptimal control appeared consistent across most, but not all, VAMC catchment areas, with non-Hispanic Black and Hispanic veterans having a higher odds of suboptimal diabetes control than non-Hispanic White veterans.

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.

The Association of Abnormal Liver Tests with Hepatitis C Testing in Primary Care.

BACKGROUND: As hepatitis C virus birth cohort (1945-1965) screening in primary care improves, testing patterns in response to persistently abnormal liver tests are less well known. METHODS: This retrospective cohort study of a patient-centered medical home between 2007 and 2016 evaluates the association of abnormal liver chemistries and other clinical and demographic factors with hepatitis C antibody (HCV Ab) testing in patients with persistently abnormal liver tests. Patients with at least 2 consecutive abnormal liver tests were categorized by the clinical pattern of liver chemistry abnormality, including cholestatic, hepatocellular, and mixed patterns. The primary outcomes were: 1) completed HCV Ab tests; and 2) positive HCV Ab results for those patients tested. RESULTS: Of 4512 patients with consecutive abnormal liver tests, only 730 (16%) underwent HCV Ab testing within 1 year of the second abnormality; 81/730 (11%) had HCV Ab detected. A logistic regression model revealed that mixed (odds ratio [OR] 2.20; 95% confidence interval [CI], 1.72-2.82) and hepatocellular (OR 1.43; 95% CI, 1.15-1.79) patterns of liver test abnormality, female sex, and alcohol and tobacco abuse were associated with higher odds of HCV Ab testing. Hepatocellular (OR 7.51; 95% CI, 2.18-25.94) and mixed patterns (OR 5.88; 95% CI, 1.64-21.15) of liver test abnormalities, male sex, Medicaid enrollment, and drug and tobacco abuse had higher odds of positive HCV Ab results. CONCLUSIONS: There is opportunity to improve hepatitis C diagnostic testing in patients with consecutively elevated liver tests, and hepatocellular and mixed patterns of abnormality should prompt primary care providers to action.

Association of a School-Based, Asthma-Focused Telehealth Program With Emergency Department Visits Among Children Enrolled in South Carolina Medicaid.

IMPORTANCE: Telehealth may improve access to care for populations in rural communities. However, little is known about the effectiveness of telehealth programs designed for children. OBJECTIVE: To examine the associations of a school-based telehealth program in Williamsburg county (South Carolina) with all-cause emergency department (ED) visits made by children enrolled in Medicaid. DESIGN, SETTING, AND PARTICIPANTS: This Medicaid claims data analysis was conducted in Williamsburg county and 4 surrounding counties in South Carolina and included children aged 3 to 17 years who were enrolled in Medicaid and living in any of the 5 counties from January 2012 to December 2017. Williamsburg served as the intervention and the 4 surrounding counties without a telehealth program as the control; 2012 to 2014 was designated as the preintervention period, whereas 2015 to 2017 served as the postintervention period. The study was designed with a difference-in-differences specification, in which the unit-of-analysis was a child-month, and a subsample included children with asthma. The data analysis was performed from July 2018 to February 2019. EXPOSURES: The school-based telehealth program implemented in Williamsburg county in 2015. MAIN OUTCOMES AND MEASURES: The binary outcome was the status of at least 1 all-cause ED visit by a child in a given month. RESULTS: The full sample included 2 443 405 child-months from 23 198 children in Williamsburg county and 213 164 children in the control counties. The mean (SD) proportions of monthly ED visits in Williamsburg were 3.65% (0.10%) during the preintervention and 3.87% (0.11%) during the postintervention. The corresponding proportions of the 4 control counties were 3.37% preintervention (0.04%), and 3.56% postintervention (0.04%), respectively. The trends in the proportion were paralleled. In the asthma subsample, the proportions in Williamsburg were 3.16% (0.31%) during the preintervention and 3.38% (0.34%) during the postintervention, respectively. The proportions for the control counties were 3.02% preintervention (0.10%) and 3.90% postintervention (0.11%), respectively. There was an interaction of the proportions between the pre/postintervention period and the intervention/control counties in this subsample. The regression analysis of the full sample showed no association of the telehealth program with ED visits. The additional analysis of the asthma subsample showed that this program was associated with a reduction of 0.66 (95% CI, -1.16 to -0.17; P < .01) percentage point per 100 children per month in ED visits, representing an approximately 21% relative decrease. CONCLUSIONS AND RELEVANCE: Although we found no association of this program with the ED visits of the overall studied population, this study suggests that telehealth with a focus on chronic pediatric diseases, such as asthma, may deliver substantial health benefits to rural and medically underserved communities.

When Do Clinicians Follow-up Abnormal Liver Tests in Primary Care?

BACKGROUND: Many guidelines addressing the approach to abnormal liver chemistries, including bilirubin, transaminases and alkaline phosphatase, recommend repeating the tests. However, when clinicians repeat testing is unknown. MATERIAL AND METHODS: This retrospective study followed adult patients with abnormal liver chemistries in a patient-centered medical home (PCMH) from 2007 to 2016. All PCMH patients possessing at least 1 abnormal liver test (total bilirubin, aminotransferases and alkaline phosphatase) were included. Patients were followed from the index abnormal liver chemistry until the next liver test result, or the end of the study period. The primary predictor variable of interest was the number of abnormal chemistries (out of 4) on index testing. Demographic and clinical variables served as other potential predictors of outcome. A Cox proportional hazards model was applied to investigate associations between the predictor variables and the time to repeat liver chemistry testing. RESULTS: Of 9,545 patients with at least 2 PCMH visits and 1 liver test abnormality, 6,489 (68%) obtained repeat testing within 1 year, and 80% of patients had follow-up tests within 2 years. Patients with multiple abnormal liver tests and those with higher degrees of abnormality were associated with shorter time to repeat testing. CONCLUSIONS: A large proportion of patients with abnormal liver tests still lack repeat testing at 1 year. The number of liver abnormal liver tests and degree of elevation were inversely associated with the time to repeat testing.

Population-based screening of hepatitis C virus in the United States.

PURPOSE OF REVIEW: This review summarized the recent evidence on the performance of population-based hepatitis C virus (HCV) screening, published and indexed to PubMed, in the Unite States during the 2-year window from 1 January 2017 to 31 December 2018. RECENT FINDINGS: A majority of the selected articles in this review focused on the birth cohort 1945-1965 because of the HCV screening recommendations released after August 2012. However, the articles for the high-risk population applied to all ages because the recommendations for this specific population have remained largely unchanged since 1998. The reported rates of HCV screening varied substantially not only across the three different populations (i.e. general, underserved, and high-risk) but also within each population. SUMMARY: More vigilant monitoring of HCV screening performance of younger birth cohorts is needed as these individuals have been experiencing a higher incidence of HCV infection than those in the birth cohort 1945-1965. In addition, to meet the goal of eliminating HCV infection as a US public health problem by 2030, significant improvement in more accurately and comprehensively reporting the trends in population-based HCV screening across different populations is warranted in the future.

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.

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.

Effects of the US Food and Drug Administration Boxed Warning of Erythropoietin-Stimulating Agents on Utilization and Adverse Outcome.

Purpose In March 2007, a US Food and Drug Administration boxed warning was issued for erythropoietin-stimulating agents (ESAs) regarding serious adverse events, such as venous thromboembolism (VTE). We evaluated the US Food and Drug Administration's boxed warning of ESAs used to treat chemotherapy-induced anemia because evidence on the effectiveness of boxed warnings remains inconclusive. Patients and Methods Using 2004 to 2009 SEER-Medicare data, we exploited a natural experiment to examine the effects of ESA boxed warnings on utilization and risk of VTE. The intervention group included Medicare fee-for-services patients diagnosed with colorectal, breast, or lung cancers targeted by this warning and undergoing chemotherapy; the control group included patients with myelodysplastic syndromes not targeted by this warning. The period from January 2004 to September 2006 was used as the prewarning period; the period from April 2007 to September 2009 was used as the postwarning period. The two binary dependent variables included ESA use and hospitalized VTE. Linear probability models with a difference-in-differences specification were used for estimation. Results Our sample consisted of 45,319 unique patients between 2004 and 2009. The trends in ESA use remained similar between the intervention and control groups before the warning, but started declining sharply in the intervention group only after the warning. The trends in hospitalized VTE were relatively stable. Regressions showed that the ESA boxed warning was associated with a 20.2-percentage-point reduction ( P < .001) in the likelihood of ESAs being used to treat cancers targeted by the warning, but not significantly associated with the likelihood of hospitalized VTE. Conclusion Our study showed that the warning was effective in reducing ESA utilization. Future studies should examine other regulatory drug safety actions, such as the Risk Evaluation and Mitigation Strategy initiative, whose effectiveness remains unknown.

Overuse of colorectal cancer screening services in the United States and its implications.

As a standard way for prevention and early detection of colorectal cancer (CRC), colonoscopy has been used for CRC screening in the United States for more than one decade. An article entitled "Assessing Colorectal Cancer Screening Adherence of Medicare Fee-For-Service Beneficiaries Age 76 to 95 Years" recently published at the Journal of Oncology Practice reports the trends in overuse of CRC screening services among average-risk elderly populations at the age of 76-95 years. Several reasons for overusing colonoscopy have been postulated, and some strategies for reducing overuse of CRC screening services have also been proposed.

Assessing Colorectal Cancer Screening Adherence of Medicare Fee-for-Service Beneficiaries Age 76 to 95 Years.

INTRODUCTION: There are concerns about potential overuse of colorectal cancer (CRC) screening services among average-risk individuals older than age 75 years. MATERIALS AND METHODS: Using a 5% random noncancer sample of Medicare beneficiaries who resided in the SEER areas, we examined rates of CRC screening adherence, defined by the Medicare coverage policy, among average-risk fee-for-service beneficiaries age 76 to 95 years from 2002 to 2010. The two outcomes are the status of overall CRC screening adherence, and the status of adherence to colonoscopy (v other modalities) conditional on patient adherence. RESULTS: Overall CRC screening adherence rates of Medicare beneficiaries age 76 to 95 years increased from 13.0% to 21.4% from 2002 to 2010. In 2002, 2.2% of beneficiaries were adherent to colonoscopy, and 10.7%, by other modalities; the corresponding rates were 19.5% and 1.9%, respectively, in 2010. Specifically, rates of adherence to colonoscopy were 1.1% for those age 86 to 90 years and almost nil for those age 91 to 95 years in 2002, but the rates became 13.5% and 8.2%, respectively, in 2010. Compared with white beneficiaries, black beneficiaries age 76 to 95 years had a 7-percentage-point lower adherence rate. However, overall adherence rates among blacks increased by 168.6% from 2002 to 2010, whereas rates among whites increased by 63.0%. Logistic regressions showed that blacks age 86 to 95 years were less likely than whites to be adherent (odds ratio, 0.56; 95% CI, 0.47 to 0.59) but were more likely to be adherent to colonoscopy (odds ratio, 2.34; 95% CI, 1.47 to 3.91). CONCLUSION: High proportions of average-risk Medicare fee-for-service beneficiaries screened by colonoscopy may represent opportunities for improving appropriateness and allocative efficiency of CRC screening by Medicare.

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."