Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans.

BACKGROUND: Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital. METHODS/DESIGN: Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months. RESULTS: A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%. CONCLUSION: We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD. TRIAL REGISTRATION: NCT01978951 ; Date or Registration: 1/17/2014.

Adherence to Diabetes Medications and Health Care Use During the COVID-19 Pandemic Among High-Risk Patients.

INTRODUCTION: The COVID-19 pandemic caused potentially disruptive shocks to chronic condition care. We examined how diabetes medication adherence, related hospitalizations, and primary care use changed in high-risk veterans prepandemic and postpandemic. METHODS: We conducted longitudinal analyses on a cohort of high-risk diabetes patients in the Veterans Affairs (VA) health care system. Primary care visits by modality, medication adherence, and VA acute hospitalizations and emergency department (ED) visits were measured. We also estimated differences for subgroups of patients by race/ethnicity, age, and rural/urban location. RESULTS: Patients were 95% male with mean age 68 years. Prepandemic patients received a mean per quarter of 1.5 in-person primary care visits and 1.3 virtual visits, 0.10 hospitalizations, and 0.22 ED visits, with mean adherence of 0.82. The early pandemic was associated with fewer in-person primary care visits, more virtual visits, fewer hospitalizations and ED visits per patient, and no change in adherence; there were no midpandemic versus prepandemic differences in hospitalizations or adherence. Black and nonelderly patients had lower adherence during the pandemic. CONCLUSION: Adherence to diabetes medications and primary care use remained high for most patients even though virtual care replaced in-person care. Black and nonelderly patients may require additional intervention to address lower adherence.

Virtual Management of Chronic Conditions During the COVID-19 Pandemic: Insights From Primary Care Providers and Clinical Pharmacists.

INTRODUCTION: The abrupt change in care delivery caused by the coronavirus disease 2019 pandemic may have left some patients, particularly those with chronic conditions, unable to receive timely and appropriate routine care. Understanding the effect of the pandemic and the switch to virtual care for patients with chronic conditions requires in-depth qualitative feedback from providers who care for these patients. MATERIALS AND METHODS: We interviewed 13 primary care providers and clinical pharmacists from the Veterans Health Administration. Interviews elicited experiences managing patients with chronic conditions, specifically diabetes and hypertension, during the coronavirus disease 2019 pandemic. We employed a rapid analytic approach for data analysis. RESULTS: In general, interview participants maintained that most patients' chronic conditions could be managed remotely without significant disruption. However, patients who lack familiarity with technology and/or reliable broadband access, patients not compliant with recommended self-assessments, and older patients with hearing loss or cognitive disorders may be more difficult to manage virtually. Although providers reported minimal disruptions to care because of the pandemic, they did note that the closure of labs and experiences of social isolation may have negatively impacted patients. Providers suggested optimizing virtual management through more robust patient instruction on virtual care technology, increased use of Veterans Affairs home health services, and removing institutional barriers that may de-incentivize virtual care modalities. CONCLUSIONS: For many patients with chronic conditions, virtual care is a promising approach to provide ongoing management in primary care. However, more tailored strategies may be needed to care for sicker, more vulnerable patients.

Screening for CKD To Improve Processes of Care among Nondiabetic Veterans with Hypertension: A Pragmatic Cluster-Randomized Trial.

BACKGROUND AND OBJECTIVES: We conducted a pilot, pragmatic, cluster-randomized trial to evaluate feasibility and preliminary effectiveness of screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio), followed by education and guidance, to improve care of hypertensive veterans in primary care. We used the electronic health record for identification, enrollment, intervention delivery, and outcome ascertainment. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We randomized 1819 veterans without diabetes but with hypertension (41 clusters) into three arms: (1) CKD screening followed by patient and provider education; (2) screening, education, plus pharmacist comanagement; or (3) usual care. The primary clinical outcome was BP change over 1 year. Implementation and process measures included proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics. RESULTS: Median age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure. Among those in the intervention, 527 of 1215 (43%) were identified with upcoming appointments to have CKD screening. Of these, 367 (69%) completed testing. Among those tested, 77 (21%) persons had newly diagnosed CKD. After 1 year, change in systolic BP was -1 mm Hg (interquartile range, -11 to 11) in usual care, -2 mm Hg (-11 to 11) in the screen-educate arm, and -2 mm Hg (-13 to 10) in the screen-educate plus pharmacist arm; P=0.49. There were no significant differences in secondary outcomes in intention-to-treat analyses. In as-treated analyses, higher proportions of participants in the intervention arms initiated a renin-angiotensin system inhibitor (15% and 12% versus 7% in usual care, P=0.01) or diuretic (9% and 12% versus 4%, P=0.03). CONCLUSIONS: The pragmatic design made identification, enrollment, and intervention delivery highly efficient. The limited ability to identify appointments resulted in inadequate between-arm differences in CKD testing rates to determine whether screening improves clinical outcomes.

Experts stress both wellness and amenity aspects of food and nutrition services in assisted living facilities for older adults.

OBJECTIVES: There has been no consensus on best practices in food and nutrition services in assisted living facilities for older adults. We documented experts' views on optimal food and nutrition services emphases in assisted living facilities, and factors affecting their views. METHODS: One hundred thirty-five national experts specializing in health, aging, nutrition and assisted living facilities completed a survey consisting four scenarios (ie, home-style, restaurant/hotel, and health/medical, and a combination of these three) in six food and nutrition services areas: dining room environment, meal services, meal quality, nutrition services, employees' qualifications, and therapeutic nutrition services. RESULTS: Sixty-three percent of experts favored the combination scenario. Dietetics education and experts' beliefs that assisted living facilities should be health promotion and maintenance facilities were significant predictors of emphases, including wellness considerations. Experts' personal views exerted a powerful influence. CONCLUSIONS: Experts chose food and nutrition service quality indicators that emphasized a focus on both wellness and amenities as their ideal scenarios for optimal food and nutrition services in assisted living facilities.

Practitioners' opinions on Food and Nutrition Care Indicators in assisted living facilities for older adults.

This study assessed the utility of the 57-indicator Food and Nutrition Care Indicators Checklist for assessing food and nutrition services in assisted-living facilities for older adults among registered dietitians (RDs). They were members of two American Dietetic Association practice groups focusing on aging and long-term care and were also employed in assisted-living facilities. The 1,281 respondents rated the importance of each checklist item and provided their views on the role of assisted-living facilities and their level of agreement with statements regarding the importance of residents' autonomy for making food choices and their ability to make wise dietary choices. Registered dietitians practicing in assisted-living facilities considered all of the domains on food and nutrition quality indicators on the Food and Nutrition Care Indicators Checklist to be highly important (92% of dining room environment items, 83% of foodservice operations, 92% of general nutrition, and 89% of therapeutic nutrition items). They preferred a service style that included both health and amenities, as did national health and aging experts. Registered dietitians should work with other professionals to further validate the checklist, promote its use, and establish optimal service models for food and nutrition services in assisted-living facilities for older adults.

Role of acetylcholinesterase and glutathione S-transferase following exposure to nicosulfuron and diazinon in Helicoverpa zea.

The acute toxicity of diazinon combined with the herbicide nicosulfuron was determined using the corn earworm, Helicoverpa zea. Nicosulfuron significantly increased toxicity of diazinon to H. zea compared to diazinon alone based on dip bioassays to evaluate acute contact toxicity. Diazinon, an organophosphorous insecticide, controls insects by inhibiting acetylcholinesterase in the nervous system. Acetylcholinesterase activity was significantly altered in corn earworms exposed to binary mixtures compared to those exposed to diazinon alone; however, the activity did not correspond consistently with toxicity. Glutathione S-transferase (GST), also known to be altered by organophosphorous insecticides, did not exhibit significant changes following exposures to diazinon, nicosulfuron, or binary mixtures. Our results suggest that nicosulfuron increases toxicity of diazinon but the mechanism of toxicity does not appear to be correlated with acetylcholinesterase or GST inhibition.

Reassessment of id1 protein expression in human mammary, prostate, and bladder cancers using a monospecific rabbit monoclonal anti-id1 antibody.

Id proteins are a class of dominant-negative antagonists of helix-loop-helix transcription factors and have been shown to control differentiation of a variety of cell types in diverse organisms. Although the importance of Id1 in tumor endothelial cells is well established, the expression and role of the Id1 protein in human cancer cells is controversial. To explore this issue, we developed and characterized a highly specific rabbit monoclonal antibody against Id1 to assess its expression in human breast, prostate, and bladder malignancies. Our results show that in usual types of human mammary carcinomas, the Id1 protein is expressed exclusively in the endothelium. Interestingly, we detected nuclear expression of the Id1 protein in the tumor cells in 10 of 45 cases of poorly differentiated and highly aggressive carcinoma with metaplastic morphology. Similarly, only 1 of 30 prostate cancer samples showed Id1-positive tumor cells, whereas in almost all, endothelial cells showed high Id1 expression. Intriguingly, whereas normal prostate glands do not show any Id1 protein expression, basal layer cells of benign prostate glands in proximity to tumors expressed high levels of the Id1 protein. In contrast to the lack of Id1 expression in the usual types of mammary and prostate cancers, the majority of transitional cell bladder tumors showed Id1 protein expression in both tumor and endothelial cells. These results suggest that further refinement of Id1 expression patterns in a variety of tumor types will be necessary to identify and study the functional roles played by Id1 in human neoplastic processes.

Food and nutrition care indicators: experts' views on quality indicators for food and nutrition services in assisted-living facilities for older adults.

This study assessed the views of 153 national experts in nutrition, health, and aging services in assisted-living facilities; including gerontological nutrition (39%), foodservice (14%), aging and disability (22%), geriatric medicine (9%), and assisted living (16%); on the practices that serve as indicators of the quality of food and nutrition services provided in assisted-living facilities and ascertained the most favored style of service delivery: health, amenities, or both. An 88-item Food and Nutrition Care Indicators survey was developed from assisted-living facility regulations in 50 states and other quality indicators of nutrition services. Respondents rated each item on a scale from 1 (not important) to 5 (extremely important). Results show that at least 80% of experts rated the majority of indicators in each domain as highly important (57% of dining room, 67% of foodservice indicators, 65% of general nutrition, and 70% of therapeutic nutrition indicators). Most experts (89%) rated a combination of indicators that included both health (general and therapeutic) and amenities service styles as being highly important. The 57 items rated most important were consolidated into a checklist. A service model that incorporates all of these elements appears to be most appropriate.

What food and nutrition services should be regulated in assisted-living facilities for older adults?

The opinions of both national aging and health experts and practicing registered dietitians (RDs) were surveyed on which key quality indicators from the Food And Nutrition Care Indicators checklist should be regulated in assisted-living facilities (ALFs) for older adults. The extent to which the practices on which the indicators were based should be regulated, and which were in fact included in the current regulations of the 50 states was also studied. One hundred fifty-three national aging and health experts were surveyed in 2005 and 882 practicing RDs who were members of two American Dietetic Association dietetic practice groups employed in ALFs were surveyed in 2006. Both the experts and the RDs believed that the need for regulations in ALF food and nutrition services was vital for about a third of the indicators, (eg, 18 items on the 57 item checklist), particularly those involving facilities and staffing. For seven out of the 18 indicators, there was substantial consensus between experts and RDs. Only three of the seven indicators were addressed by regulations in more than half of the states. Consensus exists among experts and RDs that a small but significant number of food and nutrition service indicators need to be regulated.

Lead-induced alterations of apoptosis and neurotrophic factor mRNA in the developing rat cortex, hippocampus, and cerebellum.

Previous reports have recently shown the prototypic neurotoxicant, lead, to induce apoptosis in the brains of developing organisms. In the current study, timed-pregnant rats were exposed to lead acetate (0.2% in the drinking water) 24 h following birth at postnatal day 1 (PND 1). Dams and pups were continuously exposed to lead through the drinking water of the dam until PND 20. Postnatal exposure in the pups resulted in altered mRNA levels of the following apoptotic and neurotrophic factors: caspase 2 and 3, bax, bcl-x, brain-derived neurotrophic factor (BDNF). Ribonuclease protection assays were conducted to measure the factors simultaneously at the following postnatal time points: 9, 12, 15, 20, 25, days. Our results suggest a brain region- and time-specific response following lead acetate exposure. The region most vulnerable to alterations occurs in the hippocampus with alterations beginning at PND 12, in which caspase 3, bcl-x, BDNF increase with lead exposure. Significant treatment effects were not observed for both the cortex and cerebellum.

Time for assessment of nutrition services in assisted living facilities.

State regulations on the food and nutrition service components of care influence both care and service delivery of the elderly in assisted living facilities. Information on such regulations was abstracted from a survey of 50 states that had been carried out by the National Academy for State Health Policy. These data were supplemented by examining relevant state websites and by follow up phone calls. They were then evaluated using criteria recommended by expert groups. Forty-five states had some relevant food service and nutrition regulations, and five had no specific regulations. No state had regulations meeting all the criteria examined. The availability and completeness of food and nutrition regulations and standards in assisted living facilities may have life safety implications for older adults, and they deserve further evaluation.