Leveraging home health aides to improve outcomes in heart failure: A pilot study protocol.

Heart failure (HF) affects six million people in the U.S., is associated with high morbidity, mortality, and healthcare utilization.(1, 2) Despite a decade of innovation, the majority of interventions aimed at reducing hospitalization and readmissions in HF have not been successful.(3-7) One reason may be that most have overlooked the role of home health aides and attendants (HHAs), who are often highly involved in HF care.(8-13) Despite their contributions, studies have found that HHAs lack specific HF training and have difficulty reaching their nursing supervisors when they need urgent help with their patients. Here we describe the protocol for a pilot randomized control trial (pRCT) assessing a novel stakeholder-engaged intervention that provides HHAs with a) HF training (enhanced usual care arm) and b) HF training plus a mobile health application that allows them to chat with a nurse in real-time (intervention arm). In collaboration with the VNS Health of New York, NY, we will conduct a single-site parallel arm pRCT with 104 participants (HHAs) to evaluate the feasibility, acceptability, and effectiveness (primary outcomes: HF knowledge; HF caregiving self-efficacy) of the intervention among HHAs caring for HF patients. We hypothesize that educating and better integrating HHAs into the care team can improve their ability to provide support for patients and outcomes for HF patients as well (exploratory outcomes include hospitalization, emergency department visits, and readmission). This study offers a novel and potentially scalable way to leverage the HHA workforce and improve the outcomes of the patients for whom they care. Clinical trial.gov registration: NCT04239911.

Testing an Intervention to Improve Health Care Worker Well-Being During the COVID-19 Pandemic: A Cluster Randomized Clinical Trial.

Importance: Stress First Aid is an evidence-informed peer-to-peer support intervention to mitigate the effect of the COVID-19 pandemic on the well-being of health care workers (HCWs). Objective: To evaluate the effectiveness of a tailored peer-to-peer support intervention compared with usual care to support HCWs' well-being at hospitals and federally qualified health centers (FQHCs) during the COVID-19 pandemic. Design, Setting, and Participants: This cluster randomized clinical trial comprised 3 cohorts of HCWs who were enrolled from March 2021 through July 2022 at 28 hospitals and FQHCs in the US. Participating sites were matched as pairs by type, size, and COVID-19 burden and then randomized to the intervention arm or usual care arm (any programs already in place to support HCW well-being). The HCWs were surveyed before and after peer-to-peer support intervention implementation. Intention-to-treat (ITT) analysis was used to evaluate the intervention's effect on outcomes, including general psychological distress and posttraumatic stress disorder (PTSD). Intervention: The peer-to-peer support intervention was delivered to HCWs by site champions who received training and subsequently trained the HCWs at their site. Recipients of the intervention were taught to respond to their own and their peers' stress reactions. Main Outcomes and Measures: Primary outcomes were general psychological distress and PTSD. General psychological distress was measured with the Kessler 6 instrument, and PTSD was measured with the PTSD Checklist. Results: A total of 28 hospitals and FQHCs with 2077 HCWs participated. Both preintervention and postintervention surveys were completed by 2077 HCWs, for an overall response rate of 28% (41% at FQHCs and 26% at hospitals). A total of 862 individuals (696 females [80.7%]) were from sites that were randomly assigned to the intervention arm; the baseline mean (SD) psychological distress score was 5.86 (5.70) and the baseline mean (SD) PTSD score was 16.11 (16.07). A total of 1215 individuals (947 females [78.2%]) were from sites assigned to the usual care arm; the baseline mean (SD) psychological distress score was 5.98 (5.62) and the baseline mean (SD) PTSD score was 16.40 (16.43). Adherence to the intervention was 70% for FQHCs and 32% for hospitals. The ITT analyses revealed no overall treatment effect for psychological distress score (0.238 [95% CI, -0.310 to 0.785] points) or PTSD symptom score (0.189 [95% CI, -1.068 to 1.446] points). Post hoc analyses examined the heterogeneity of treatment effect by age group with consistent age effects observed across primary outcomes (psychological distress and PTSD). Among HCWs in FQHCs, there were significant and clinically meaningful treatment effects for HCWs 30 years or younger: a more than 4-point reduction for psychological distress (-4.552 [95% CI, -8.067 to -1.037]) and a nearly 7-point reduction for PTSD symptom scores (-6.771 [95% CI, -13.224 to -0.318]). Conclusions and Relevance: This trial found that this peer-to-peer support intervention did not improve well-being outcomes for HCWs overall but had a protective effect against general psychological distress and PTSD in HCWs aged 30 years or younger in FQHCs, which had higher intervention adherence. Incorporating this peer-to-peer support intervention into medical training, with ongoing support over time, may yield beneficial results in both standard care and during public health crises. Trial Registration: ClinicalTrials.gov Identifier: NCT04723576.

Effect of the DASH diet on the sodium-chloride cotransporter and aquaporin-2 in urinary extracellular vesicles.

The dietary approach to stop hypertension (DASH) diet combines the antihypertensive effect of a low sodium and high potassium diet. In particular, the potassium component of the diet acts as a switch in the distal convoluted tubule to reduce sodium reabsorption, similar to a diuretic but without the side effects. Previous trials to understand the mechanism of the DASH diet were based on animal models and did not characterize changes in human ion channel protein abundance. More recently, protein cargo of urinary extracellular vesicles (uEVs) has been shown to mirror tissue content and physiological changes within the kidney. We designed an inpatient open label nutritional study transitioning hypertensive volunteers from an American style diet to DASH diet to examine physiological changes in adults with stage 1 hypertension otherwise untreated (Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. N Engl J Med 344: 3-10, 2001). Urine samples from this study were used for proteomic characterization of a large range of pure uEVs (small to large) to reveal kidney epithelium changes in response to the DASH diet. These samples were collected from nine volunteers at three time points, and mass spectrometry identified 1,800 proteins from all 27 samples. We demonstrated an increase in total SLC12A3 [sodium-chloride cotransporter (NCC)] abundance and a decrease in aquaporin-2 (AQP2) in uEVs with this mass spectrometry analysis, immunoblotting revealed a significant increase in the proportion of activated (phosphorylated) NCC to total NCC and a decrease in AQP2 from day 5 to day 11. This data demonstrates that the human kidney's response to nutritional interventions may be captured noninvasively by uEV protein abundance changes. Future studies need to confirm these findings in a larger cohort and focus on which factor drove the changes in NCC and AQP2, to which degree NCC and AQP2 contributed to the antihypertensive effect and address if some uEVs function also as a waste pathway for functionally inactive proteins rather than mirroring protein changes.NEW & NOTEWORTHY Numerous studies link DASH diet to lower blood pressure, but its mechanism is unclear. Urinary extracellular vesicles (uEVs) offer noninvasive insights, potentially replacing tissue sampling. Transitioning to DASH diet alters kidney transporters in our stage 1 hypertension cohort: AQP2 decreases, NCC increases in uEVs. This aligns with increased urine volume, reduced sodium reabsorption, and blood pressure decline. Our data highlight uEV protein changes as diet markers, suggesting some uEVs may function as waste pathways. We analyzed larger EVs alongside small EVs, and NCC in immunoblots across its molecular weight range.

Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, Setting, and Participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main Outcomes and Measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and Relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial Registration: ClinicalTrials.gov Identifier: NCT02933970.

Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings.

INTRODUCTION: Posttraumatic stress disorder (PTSD) results in substantial costs to society. Prevalence of PTSD among adults is high, especially among those presenting to primary care settings. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination and implementation within primary care settings is challenging. Building Experience for Treating Trauma and Enhancing Resilience (BETTER) examines the effectiveness of integrating Written Exposure Therapy (WET) within primary care collaborative care management (CoCM). WET is a brief exposure-based treatment that has the potential to address many challenges of delivering PTSD EBPs within primary care settings. METHODS: The study is a hybrid implementation effectiveness cluster-randomized controlled trial in which 12 Federally Qualified Health Centers (FQHCs) will be randomized to either CoCM plus WET (CoCM+WET) or CoCM only with 60 patients within each FQHC. The primary aim is to evaluate the effectiveness of CoCM+WET to improve PTSD and depression symptom severity. Secondary treatment outcomes are mental and physical health functioning. The second study aim is to examine implementation of WET within FQHCs using FQHC process data and staff interviews pre- and post-intervention. Exploratory aims are to examine potential moderators and mediators of the intervention. Assessments occur at baseline, and 3- and 12-month follow-up. CONCLUSION: The study has the potential to impact practice and improve clinical and public health outcomes. By establishing the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care, the study aims to improve PTSD outcomes for underserved patients. TRIAL REGISTRATION: (Clinicaltrials.govNCT05330442).

Molecular Epidemiologic and Geo-Spatial Characterization of Staphylococcus aureus Cultured from Skin and Soft Tissue Infections from United States-Born and Immigrant Patients Living in New York City.

(1) Background: With increasing international travel and mass population displacement due to war, famine, climate change, and immigration, pathogens, such as Staphylococcus aureus (S. aureus), can also spread across borders. Methicillin-resistant S. aureus (MRSA) most commonly causes skin and soft tissue infections (SSTIs), as well as more invasive infections. One clonal strain, S. aureus USA300, originating in the United States, has spread worldwide. We hypothesized that S. aureus USA300 would still be the leading clonal strain among US-born compared to non-US-born residents, even though risk factors for SSTIs may be similar in these two populations (2) Methods: In this study, 421 participants presenting with SSTIs were enrolled from six community health centers (CHCs) in New York City. The prevalence, risk factors, and molecular characteristics for MRSA and specifically clonal strain USA300 were examined in relation to the patients' self-identified country of birth. (3) Results: Patients born in the US were more likely to have S. aureus SSTIs identified as MRSA USA300. While being male and sharing hygiene products with others were also significant risks for MRSA SSTI, we found exposure to animals, such as owning a pet or working at an animal facility, was specifically associated with risk for SSTIs caused by MRSA USA300. Latin American USA300 variant (LV USA300) was most common in participants born in Latin America. Spatial analysis showed that MRSA USA300 SSTI cases were more clustered together compared to other clonal types either from MRSA or methicillin-sensitive S. aureus (MSSA) SSTI cases. (4) Conclusions: Immigrants with S. aureus infections have unique risk factors and S. aureus molecular characteristics that may differ from US-born patients. Hence, it is important to identify birthplace in MRSA surveillance and monitoring. Spatial analysis may also capture additional information for surveillance that other methods do not.

Acute Experiences of Negative Interpersonal Interactions: Examining the Dynamics of Negative Mood and Ambulatory Blood Pressure Responses Among Black and Hispanic Urban Adults.

BACKGROUND: Negative interpersonal interactions are associated with acute increases in ambulatory blood pressure (ABP). Yet, the mechanisms underlying this relationship are unclear. PURPOSE: This study tested whether negative interpersonal interactions predict higher ABP both in the moment and during subsequent observations, and whether increases in negative mood mediate these relations. These associations were tested among Black and Hispanic urban adults who may be at higher risk for negative interpersonal interactions as a function of discrimination. Race/ethnicity and lifetime discrimination were tested as moderators. METHODS: Using a 24-hr ecological momentary assessment (EMA) design, 565 Black and Hispanic participants (aged 23-65, M = 39.06, SD = 9.35; 51.68% men) had their ABP assessed every 20 min during daytime accompanied by an assessment of negative interpersonal interactions and mood. This produced 12,171 paired assessments of ABP and self-reports of participants' interpersonal interactions, including how much the interaction made them feel left out, harassed, and treated unfairly, as well as how angry, nervous, and sad they felt. RESULTS: Multilevel models revealed that more intense negative interpersonal interactions predicted higher momentary ABP. Mediation analyses revealed that increased negative mood explained the relationship between negative interpersonal interactions and ABP in concurrent and lagged analyses. Discrimination was associated with more negative interpersonal interactions, but neither race/ethnicity nor lifetime discrimination moderated findings. CONCLUSIONS: Results provide a clearer understanding of the psychobiological mechanisms through which interpersonal interactions influence cardiovascular health and may contribute to health disparities. Implications include the potential for just-in-time interventions to provide mood restoring resources after negative interactions.

Being mistreated by others has been shown to have negative impacts on cardiovascular health, including higher blood pressure (BP) levels. Yet, it is not clear why this mistreatment leads to increased and sustained influences on BP. In this paper, among a sample of Black and Hispanic urban adults, we studied whether changes in negative mood after being treated unfairly, excluded, or harassed explained the reason for higher BP levels. Participants completed reports of how they were treated in recent social interactions, and their levels of negative mood they were feeling at the current moment, every 20 min for 1 day. A BP measurement also occurred at each measurement. We found that negative mood was higher when a person reported being treated unfairly, excluded, and/or harassed, and that the negative mood that followed these negative interpersonal interactions accounted for increases in BP. These results have implications for how mistreatment can lead to chronic illness over time, and provides the potential for providing resources to restore mood and improve BP after mistreatment.

Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience.

Introduction: Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise. Methods and Results: Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies. Conclusions: We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.

Physical and psychosocial impact on peers with HIV co-leading an HIV intervention: A pilot theory-guided case-study.

Objective: To examine longitudinal changes in activation, HIV health outcomes, and social and psychological determinants of adherence to antiretroviral therapy (ART) among peer trainers with HIV. Methods: A multi-method case study. The study population included peers (n = 4) from a randomized controlled trial about peers training patients with HIV (n = 359) to better manage their health. Each peer completed a semi-structured interview that we analyzed using Social Learning Theory (SLT) as a guiding framework. The peers also completed longitudinal surveys about their health after each training cohort (n = 5) over 3-years. Results: Peers reported personal benefits from training others with HIV in self-management. Their self-reported activation, self-efficacy and some health outcomes increased overtime. The peers mentioned SLT principles during their interviews. Generally, the peers enjoyed and benefited from training others with HIV in a group-based learning environment. Conclusion: Our findings suggest peer leadership can serve as a means for empowerment that is effective at both supporting improvements in health outcomes for patients and for themselves, which may be both scalable and sustainable. Innovation: To our knowledge, this is the first mixed-methods study to show reciprocal long-term improvement in health behaviors in a diverse group of peers training others with HIV to self-manage their care.

Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort.

OBJECTIVE: To examine whether depression status before metabolic and bariatric surgery (MBS) influenced 5-year weight loss, diabetes, and safety/utilization outcomes in the PCORnet Bariatric Study. SUMMARY OF BACKGROUND DATA: Research on the impact of depression on MBS outcomes is inconsistent with few large, long-term studies. METHODS: Data were extracted from 23 health systems on 36,871 patients who underwent sleeve gastrectomy (SG; n=16,158) or gastric bypass (RYGB; n=20,713) from 2005-2015. Patients with and without a depression diagnosis in the year before MBS were evaluated for % total weight loss (%TWL), diabetes outcomes, and postsurgical safety/utilization (reoperations, revisions, endoscopy, hospitalizations, mortality) at 1, 3, and 5 years after MBS. RESULTS: 27.1% of SG and 33.0% of RYGB patients had preoperative depression, and they had more medical and psychiatric comorbidities than those without depression. At 5 years of follow-up, those with depression, versus those without depression, had slightly less %TWL after RYGB, but not after SG (between group difference = 0.42%TWL, P = 0.04). However, patients with depression had slightly larger HbA1c improvements after RYGB but not after SG (between group difference = - 0.19, P = 0.04). Baseline depression did not moderate diabetes remission or relapse, reoperations, revision, or mortality across operations; however, baseline depression did moderate the risk of endoscopy and repeat hospitalization across RYGB versus SG. CONCLUSIONS: Patients with depression undergoing RYGB and SG had similar weight loss, diabetes, and safety/utilization outcomes to those without depression. The effects of depression were clinically small compared to the choice of operation.

Implementing DASH-Aligned Meals and Self-Measured Blood Pressure to Reduce Hypertension at Senior Centers: A RE-AIM Analysis.

Low-income, minority seniors face high rates of hypertension that increase cardiovascular risk. Senior centers offer services, including congregate meals, that can be a valuable platform to reach older adults in underserved communities. We implemented two evidence-based interventions not previously tested in this setting: DASH-aligned congregate meals and Self-Measured Blood Pressure (SMBP), to lower blood pressure (BP) at two senior centers serving low-income, racially diverse communities. The study enrolled congregate meal program participants, provided training and support for SMPB, and nutrition and BP education. DASH-aligned meals delivered 40% (lunch) or 70% (breakfast and lunch) of DASH requirements/day. Primary outcomes were change in BP, and BP control, at Month 1. Implementation data collected included client characteristics, menu fidelity, meal attendance, SMBP adherence, meal satisfaction, input from partner organizations and stakeholders, effort, and food costs. We used the RE-AIM framework to analyze implementation. Study Reach included 94 older, racially diverse participants reflecting neighborhood characteristics. Effectiveness: change in systolic BP at Month 1 trended towards significance (-4 mmHg, p = 0.07); change in SMBP reached significance at Month 6 (-6.9 mmHg, p = 0.004). We leveraged existing community-academic partnerships, leading to Adoption at both target sites. The COVID pandemic interrupted Implementation and Maintenance and may have attenuated BP effectiveness. DASH meals served were largely aligned with planned menus. Meal attendance remained consistent; meal satisfaction was high. Food costs increased by 10%. This RE-AIM analysis highlights the acceptability, feasibility, and fidelity of this DASH/SMBP health intervention to lower BP at senior centers. It encourages future research and offers important lessons for organizations delivering services to older adults and addressing cardiovascular risk among vulnerable populations.

Comparative Safety and Effectiveness of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy for Weight Loss and Type 2 Diabetes Across Race and Ethnicity in the PCORnet Bariatric Study Cohort.

Importance: Bariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups. Objective: To compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study. Design, Setting, and Participants: This was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB or SG operation between January 1, 2005, and September 30, 2015, at participating health systems. Patient race and ethnicity included Black, Hispanic, White, other, and unrecorded. Data were analyzed from July 1, 2021, to January 17, 2022. Exposure: RYGB or SG. Outcomes: Percentage total weight loss (%TWL); type 2 diabetes remission, relapse, and change in hemoglobin A1c (HbA1c) level; and postsurgical safety and utilization outcomes (operations, interventions, revisions/conversions, endoscopy, hospitalizations, mortality, 30-day major adverse events) at 1, 3, and 5 years after surgery. Results: A total of 36 871 patients (mean [SE] age, 45.0 [11.7] years; 29 746 female patients [81%]) were included in the weight analysis. Patients identified with the following race and ethnic categories: 6891 Black (19%), 8756 Hispanic (24%), 19 645 White (53%), 826 other (2%), and 783 unrecorded (2%). Weight loss and mean reductions in HbA1c level were larger for RYGB than SG in all years for Black, Hispanic, and White patients (difference in 5-year weight loss: Black, -7.6%; 95% CI, -8.0 to -7.1; P < .001; Hispanic, -6.2%; 95% CI, -6.6 to -5.9; P < .001; White, -5.9%; 95% CI, -6.3 to -5.7; P < .001; difference in change in year 5 HbA1c level: Black, -0.29; 95% CI, -0.51 to -0.08; P = .009; Hispanic, -0.45; 95% CI, -0.61 to -0.29; P < .001; and White, -0.25; 95% CI, -0.40 to -0.11; P = .001.) The magnitude of these differences was small among racial and ethnic groups (1%-3% of %TWL). Black and Hispanic patients had higher risk of hospitalization when they had RYGB compared with SG (hazard ratio [HR], 1.45; 95% CI, 1.17-1.79; P = .001 and 1.48; 95% CI, 1.22-1.79; P < .001, respectively). Hispanic patients had greater risk of all-cause mortality (HR, 2.41; 95% CI, 1.24-4.70; P = .01) and higher odds of a 30-day major adverse event (odds ratio, 1.92; 95% CI, 1.38-2.68; P < .001) for RYGB compared with SG. There was no interaction between race and ethnicity and operation type for diabetes remission and relapse. Conclusions and Relevance: Variability of the comparative effectiveness of operations for %TWL and HbA1c level across race and ethnicity was clinically small; however, differences in safety and utilization outcomes were clinically and statistically significant for Black and Hispanic patients who had RYGB compared with SG. These findings can inform shared decision-making regarding bariatric operation choice for different racial and ethnic groups of patients.

Serum aldosterone and urine electrolytes dynamics in response to DASH diet intervention - An inpatient mechanistic study.

Background: Dietary approach to stop hypertension (DASH) diet reduces blood pressure (BP) as effectively as one antihypertensive drug, yet its mechanism of action was never fully characterized. Methods: We designed a translational inpatient trial to elucidate the biological pathway leading from nutritional change, through hormonal response, reversal of urine electrolytes ratio, to BP reduction. Results: A single-center open-label interventional trial. Volunteers were admitted for 14 days, transitioning from an American-style diet to DASH diet. Vital signs, blood, and urine samples were collected daily. Participants completed two 24-hour ambulatory BP measurements (ABPM) and two 24-hour urine collections on days 1 and 10. Nine volunteers completed the protocol. During inpatient stay, serum aldosterone increased from day 0 (mean 8.3 ± 5.0) to day 5 (mean 17.8 ± 5.8) after intervention and decreased on day 11 (mean 11.5 ± 4.7) despite continuous exposure to the same diet (p-value = 0.002). Urine electrolyte ratio ([Na]/[K]) decreased significantly from a mean of 3.5 to 1.16 on day 4 (p < 0.001). BP by 24-hour ABPM decreased by a mean of 3.7 mmHg systolic BP and 2.3 mmHg diastolic BP from day 1 to 10. Conclusion: Shifting from a high-sodium/low-potassium diet to the opposite composition leads to aldosterone increase and paradoxical BP reduction. Urine electrolyte ratio reflects nutritional changes and should guide clinicians in assessing adherence to lifestyle modification.

Implementing DASH-aligned Congregate Meals and Self-Measured Blood Pressure in two senior centers: An open label study.

BACKGROUND AND AIMS: Cardiovascular Disease (CVD) poses significant health risks for seniors, especially among low-income and minority communities. Senior centers offer multiple services. We tested whether implementing two evidence-based interventions- DASH-aligned meals provided through an existing congregate meal program, and support for home Self-Measured Blood Pressure (SMBP) monitoring-lowers blood pressure among participants at two senior centers serving low-income, racially diverse communities. METHODS AND RESULTS: Open-label study, enrolling clients aged ≥60, eating ≥4 meals/week at two NYC senior centers. Participants received DASH-aligned congregate meals, and training in nutrition, BP management education, and personal SMBP device. Co-Primary outcomes: a) change in systolic BP measured by independent health professionals, and b) change in percent with "controlled BP" (Eighth Joint National Committee (JNC-8) Guidelines), at Month 1 compared to Baseline. SECONDARY OUTCOMES: Changes in BP at Months 3 and 5/6 (last measure). We enrolled 94 participants; COVID closures interrupted implementation mid-study. Mean systolic BP at Month-1 changed by -4.41 mmHg (n = 61 p = 0.07) compared to Baseline. Participants with controlled BP increased (15.7%) at Month 1. Change in mean BP at Month 1 was significantly correlated with BMI (p = 0.02), age (p = 0.04), and baseline BP (p < 0.001). Mean systolic SMBP changed by -6.9 mmHg (p = 0.004) at Months 5/6. CONCLUSIONS: Implementing an evidence-based multi-component BP-lowering intervention within existing congregate meal programs at senior centers serving minority and low-income communities is feasible, and early findings show promising evidence of effectiveness. This approach to cardiovascular risk reduction should be further tested for widespread adoption and impact. Registered on ClinicalTrials.gov NCT03993808 (June 21st, 2019).

Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial.

INTRODUCTION: The COVID-19 pandemic has placed health care workers at unprecedented risk of stress, burnout, and moral injury. This paper describes the design of an ongoing cluster randomized controlled trial to compare the effectiveness of Stress First Aid (SFA) to Usual Care (UC) in protecting the well-being of frontline health care workers. METHODS: We plan to recruit a diverse set of hospitals and health centers (eight matched pairs of hospitals and six pairs of centers), with a goal of approximately 50 HCW per health center and 170 per hospital. Participating sites in each pair are randomly assigned to SFA or UC (i.e., whatever psychosocial support is currently being received by HCW). Each site identified a leader to provide organizational support of the study; SFA sites also identified at least one champion to be trained in the intervention. Using a "train the trainer" model, champions in turn trained their peers in selected HCW teams or units to implement SFA over an eight-week period. We surveyed HCW before and after the implementation period. The primary outcomes are posttraumatic stress disorder and general psychological distress; secondary outcomes include depression and anxiety symptoms, sleep problems, social functioning problems, burnout, moral distress, and resilience. In addition, through in-depth qualitative interviews with leaders, champions, and HCW, we assessed the implementation of SFA, including acceptability, feasibility, and uptake. DISCUSSION: Results from this study will provide initial evidence for the application of SFA to support HCW well-being during a pandemic. TRIAL REGISTRATION: (Clinicaltrials.govNCT04723576).

Obesity Related Glomerulopathy in Adolescent Women: The Effect of Body Surface Area.

Background: Adolescent obesity, a risk factor for cardiorenal morbidity in adulthood, has reached epidemic proportions. Obesity-related glomerulopathy (ORG) has an early reversible stage of hyperfiltration. Age-appropriate formulae for eGFR, which are standardized to ideal body surface area (BSA) and provide assessment of kidney function in ml/min/1.73 m2, may underestimate prevalence of early ORG. We investigated whether adjusting eGFR to actual BSA more readily identifies early ORG. Methods: We studied a cohort of 22,417 young individuals, aged 12-21 years, from a New York metropolitan multi-institutional electronic health records clinical database. eGFR was calculated in two ways: BSA-standardized eGFR, and absolute eGFR. Hyperfiltration was defined above a threshold of 135 ml/min per 1.73 m2 or 135 ml/min, respectively. The prevalence of hyperfiltration according to each formula was assessed in parallel to creatinine clearance. Results: Serum creatinine values and hyperfiltration prevalence according to BSA-standardized eGFR were similar, 13%-15%, across body mass index (BMI) groups. The prevalence of hyperfiltration determined by absolute eGFR differed across BMI groups: underweight, 2%; normal weight, 6%; overweight, 17%; and obese, 31%. This trend paralleled the rise in creatinine clearance across BMI groups. Conclusions: Absolute eGFR more readily identifies early ORG than the currently used formulae, which are adjusted to a standardized BSA and are not representative of current population BMI measures. Using absolute eGFR in clinical practice and research may improve the ability to identify, intervene, and reverse early ORG, which has great importance with increasing obesity rates.

Effect of Normalizing eGFR to Standard Body Surface Area on Rates of Obesity-Related Hyperfiltration among Diverse Female Adolescents.

INTRODUCTION: Obesity is more prevalent among African American individuals, increasing the risk for cardiorenal morbidity. We explored interactions between race, BMI, and the risk of hyperfiltration associated with obesity-related glomerulopathy (ORG). METHODS: We created a cohort of female adolescents from electronic health records. Glomerular filtration rate (GFR) was estimated in two ways: (A) using standard age recommended formulae and (B) absolute eGFR - adjusted to individual body surface area (BSA). Multivariate logistic regression was used to analyze the contribution of risk factors for ORG-associated hyperfiltration defined as 135 mL/min/1.73 m2 or 135 mL/min, according to BMI group. Pearson's coefficient was used to assess correlation with creatinine clearance (CrCl). RESULTS: The final cohort included 7,315 African American and 15,102 non-African American adolescent females, with CrCl available for internal validation in 207 non-African American and 107 African American individuals. Compared with non-African American ethnicity, African American ethnicity was independently associated with a lower risk of hyperfiltration with standard eGFR calculations (odds ratio [OR] = 0.57, 95% confidence intervals [CIs] 0.45-0.71), associations were enhanced for absolute eGFR (OR = 0.81, 95% CI 0.69-0.95). Absolute eGFR values agreed better with CrCl (r = 0.63), compared to standard indexed eGFR formulae. Proportions classified as hyperfiltration changed with standard versus absolute eGFR; they were similar across BMI groups with the first and reflected obesity with the later. CONCLUSION: Adjusting to individual BSA improves estimation of GFR and identification of obesity-related hyperfiltration. More accurate and earlier ascertainment of obesity-related hyperfiltration may have important consequences for preservation of kidney function.

Stakeholder Engagement In a Comparative Effectiveness/Implementation Study to Prevent Staphylococcus Aureus Infection Recurrence: CA-MRSA Project (CAMP2).

BACKGROUND: Methicillin-resistant or methicillin-sensitive Staphylococcus aureus skin and soft tissue infections pose serious clinical and public health challenges. Few protocols exist for outpatient education, decolonization and decontamination. OBJECTIVES: This trial implemented infection prevention protocols in homes via community health workers/Promotoras. METHODS: We engaged clinicians, patient stakeholders, clinical and laboratory researchers, New York-based federally qualified health centers and community hospital emergency departments. The Clinician and Patient Stakeholder Advisory Committee (CPSAC) convened in person and remotely for shared decision-making and trial oversight. RESULTS: The intervention trial consented participants with skin and soft tissue infections from Methicillin-resistant Staphylococcus aureus or methicillin-sensitive Staphylococcus aureus, completed home visits, obtained surveillance cultures from index patients and household members and sampled household environmental surfaces at baseline and three months. LESSONS LEARNED: The retention of the CPSAC during the trial demonstrated high levels of engagement. CONCLUSIONS: CPSAC was highly effective throughout design and execution by troubleshooting recruitment and home visit challenges.

Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial.

BACKGROUND: Shortening time between office visits for patients with uncontrolled hypertension represents a potential strategy for improving blood pressure (BP). OBJECTIVE: We evaluated the impact of multimodal strategies on time between visits and on improvement in systolic BP (SBP) among patients with uncontrolled hypertension. DESIGN: We used a stepped-wedge cluster randomized controlled trial with three wedges involving 12 federally qualified health centers with three study periods: pre-intervention, intervention, and post-intervention. PARTICIPANTS: Adult patients with diagnosed hypertension and two BPs ≥ 140/90 pre-randomization and at least one visit during post-randomization control period (N = 4277). INTERVENTION: The core intervention included three, clinician hypertension group-based trainings, monthly clinician feedback reports, and monthly meetings with practice champions to facilitate implementation. MAIN MEASURES: The main measures were change in time between visits when BP was not controlled and change in SBP. A secondary planned outcome was changed in BP control among all hypertension patients in the practices. KEY RESULTS: Median follow-up times were 34, 32, and 32 days and the mean SBPs were 142.0, 139.5, and 139.8 mmHg, respectively. In adjusted analyses, the intervention did not improve time to the next visit compared with control periods, HR = 1.01 (95% CI: 0.98, 1.04). SBP was reduced by 1.13 mmHg (95% CI: -2.10, -0.16), but was not maintained during follow-up. Hypertension control (< 140/90) in the practices improved by 5% during intervention (95% CI: 2.6%, 7.3%) and was sustained post-intervention 5.4% (95% CI: 2.6%, 8.2%). CONCLUSIONS: The intervention failed to shorten follow-up time for patients with uncontrolled BP and showed very small, statistically significant improvements in SBP that were not sustained. However, the intervention showed statistically and clinically relevant improvement in hypertension control suggesting that the intervention affected clinician decision-making regarding BP control apart from visit frequency. Future practice initiatives should consider hypertension control as a primary outcome. CLINICAL TRIAL: www.ClinicalTrials.gov Identifier: NCT02164331.