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Platelet RNA Biomarker of Ticagrelor-Responsive Genes Is Associated With Platelet Function and Cardiovascular Events

Myers, Rachel A; Ortel, Thomas L; Waldrop, Alexander; Cornwell, MacIntosh; Newman, Jonathan D; Levy, Natalie K; Barrett, Tessa J; Ruggles, Kelly; Sowa, Marcin A; Dave, Sandeep; Ginsburg, Geoffrey S; Berger, Jeffrey S; Voora, Deepak
BACKGROUND/UNASSIGNED:Identifying patients with the optimal risk:benefit for ticagrelor is challenging. The aim was to identify ticagrelor-responsive platelet transcripts as biomarkers of platelet function and cardiovascular risk. METHODS/UNASSIGNED:Healthy volunteers (n=58, discovery; n=49, validation) were exposed to 4 weeks of ticagrelor with platelet RNA data, platelet function, and self-reported bleeding measured pre-/post-ticagrelor. RNA sequencing was used to discover platelet genes affected by ticagrelor, and a subset of the most informative was summarized into a composite score and tested for validation. This score was further analyzed (1) in CD34+ megakaryocytes exposed to an P2Y12 inhibitor in vitro, (2) with baseline platelet function in healthy controls, (3) in peripheral artery disease patients (n=139) versus patient controls (n=30) without atherosclerosis, and (4) in patients with peripheral artery disease for correlation with atherosclerosis severity and risk of incident major adverse cardiovascular and limb events. RESULTS/UNASSIGNED:Ticagrelor exposure differentially expressed 3409 platelet transcripts. Of these, 111 were prioritized to calculate a Ticagrelor Exposure Signature score, which ticagrelor reproducibly increased in discovery and validation cohorts. Ticagrelor's effects on platelets transcripts positively correlated with effects of P2Y12 inhibition in primary megakaryocytes. In healthy controls, higher baseline scores correlated with lower baseline platelet function and with minor bleeding while receiving ticagrelor. In patients, lower scores independently associated with both the presence and extent of atherosclerosis and incident ischemic events. CONCLUSIONS/UNASSIGNED:Ticagrelor-responsive platelet transcripts are a biomarker for platelet function and cardiovascular risk and may have clinical utility for selecting patients with optimal risk:benefit for ticagrelor use.
PMID: 38059352
ISSN: 1524-4636
CID: 5591292

Abstract 441: Relationship Between Diabetes, Glucose Control, And Vascular Health: Findings From The American Heart Association Cardiometabolic Health Strategically Focused Research Network [Meeting Abstract]

Garshick, Michael; Barrett, Tessa A; Jindal, Manila; Newman, Jonathan D; Fadzan, Maja; Bredefeld, Cindy; Levy, Natalie; Akinlonu, Adedoyin; Heguy, Adriana; Drenkova, Schlamp, Florencia; Giannarelli, Chiara; Fisher, Edward A; Goldberg, Ira J; Berger, Jeffrey
ISSN: 1524-4636
CID: 5578852

Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices

Gupta, Avni; Hu, Jiyuan; Huang, Shengnan; Diaz, Laura; Gore, Radhika; Levy, Natalie; Bergman, Michael; Tanner, Michael; Sherman, Scott E; Islam, Nadia; Schwartz, Mark D
BACKGROUND:It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). METHODS:We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. RESULTS:Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). CONCLUSIONS:The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. TRIAL REGISTRATION:The trial was registered with on 30/12/2016 and the registration number is NCT03006666 .
PMID: 36978071
ISSN: 1471-2458
CID: 5454102

Corrigendum to "Vascular endothelium as a target for perfluroalkyl substances (PFAs)" [Environ. Res. 212 (2022) 1-4/11339]

Wittkopp, Sharine; Wu, Fen; Windheim, Joseph; Robinson, Morgan; Kannan, Kurunthachalam; Katz, Stuart D; Chen, Yu; Newman, Jonathan D; [Levy, Natalie]
PMID: 36805490
ISSN: 1096-0953
CID: 5428782

Study design of BETTER-BP: Behavioral economics trial to enhance regulation of blood pressure

Dodson, John A; Schoenthaler, Antoinette; Fonceva, Ana; Gutierrez, Yasmin; Shimbo, Daichi; Banco, Darcy; Maidman, Samuel; Olkhina, Ekaterina; Hanley, Kathleen; Lee, Carson; Levy, Natalie K; Adhikari, Samrachana
BACKGROUND/UNASSIGNED:Nonadherence to antihypertensive medications remains a persistent problem that leads to preventable morbidity and mortality. Behavioral economic strategies represent a novel way to improve antihypertensive medication adherence, but remain largely untested especially in vulnerable populations which stand to benefit the most. The Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) was designed in this context, to test whether a digitally-enabled incentive lottery improves antihypertensive adherence and reduces systolic blood pressure (SBP). DESIGN/UNASSIGNED:BETTER-BP is a pragmatic randomized trial conducted within 3 safety-net clinics in New York City: Bellevue Hospital Center, Gouveneur Hospital Center, and NYU Family Health Centers - Park Slope. The trial will randomize 435 patients with poorly controlled hypertension and poor adherence (<80% days adherent) in a 2:1 ratio (intervention:control) to receive either an incentive lottery versus passive monitoring. The incentive lottery is delivered via short messaging service (SMS) text messages that are delivered based on (1) antihypertensive adherence tracked via a wireless electronic monitoring device, paired with (2) a probability of lottery winning with variable incentives and a regret component for nonadherence. The study intervention lasts for 6 months, and ambulatory systolic blood pressure (SBP) will be measured at both 6 and 12 months to evaluate immediate and durable lottery effects. CONCLUSIONS/UNASSIGNED:BETTER-BP will generate knowledge about whether an incentive lottery is effective in vulnerable populations to improve antihypertensive medication adherence. If successful, this could lead to the implementation of this novel strategy on a larger scale to improve outcomes.
PMID: 36573193
ISSN: 2772-4875
CID: 5395042

Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach

Levy, Natalie K; Park, Agnes; Solis, Daniela; Hu, Lu; Langford, Aisha T; Wang, Binhuan; Rogers, Erin S
BACKGROUND:Social determinants of health (SDOH) refer to the social, economic, and psychosocial conditions that influence health. Lower levels of SDOH factors including income, education, and employment are associated with a higher prevalence of diabetes, poorer glycemic control, and increased diabetes-related mortality. Few studies have conducted a comprehensive evaluation of multiple SDOH factors in a population with type 2 diabetes mellitus (T2DM). OBJECTIVE:This study aimed to identify the range of SDOH challenges-including diabetes-related distress-that impact patients with insulin-dependent diabetes at an urban safety-net clinic using the 5-domain SDOH framework developed by the Healthy People 2020 initiative. METHODS:The pilot study used a cross-sectional, mixed methods approach. Participants were recruited from 3 programs within a general internal medicine clinic that provides ambulatory care for patients with uncontrolled T2DM. We administered an investigator-developed SDOH survey based on the Healthy People 2020 framework and the validated Diabetes Distress Scale (DDS), which assesses 4 domains of diabetes-related distress. One-on-one interviews were conducted to gain in-depth information about challenges. RESULTS:level of 11.0% (SD 2.6%). Overall, 92% (52/57) of participants had a barrier in at least one SDOH domain. SDOH challenges were most commonly reported in the domain of Health and Health Care (84%, 48/57), followed by Economic Stability (54%, n=31), Neighborhood and Built Environment (53%, n=30), Education and Health Literacy (47%, n=27), and Social and Community context (37%, n=21). The mean overall DDS score was 2.09 (SD 0.84), where scores of ≥2 indicate distress. Further, 79% (45/57) of participants had at least moderate diabetes-related distress in one of the 4 DDS domains. General themes that emerged from participant interviews included job interference with healthy behaviors, concerns about burdening others, challenges communicating with providers, and difficulty getting appointments in a timely manner. CONCLUSIONS:We found high levels of SDOH barriers across all 5 domains of the Center for Disease Control and Prevention's Healthy People 2020 framework, including significant levels of diabetes-related distress. Future programs to address SDOH barriers in patients with uncontrolled insulin-dependent diabetes should consider screening for and focusing on a wide range of challenges.
PMID: 36222807
ISSN: 2561-326x
CID: 5347482

Vascular endothelium as a target for perfluroalkyl substances (PFAs)

Wittkopp, Sharine; Wu, Fen; Windheim, Joseph; Robinson, Morgan; Kannan, Kurunthachalam; Katz, Stuart D; Chen, Yu; Newman, Jonathan D; [Levy, Natalie]
INTRODUCTION/BACKGROUND:Perfluoroalkyl substances (PFAs) are ubiquitous, anthropogenic organic compounds that have been linked with cardiovascular disease and cardiovascular risk factors. Older, long-chain PFAs have been phased out due to adverse cardiometabolic health effect and replaced by newer short-chain PFAs. However, emerging research suggests that short-chain PFAs may also have adverse cardiovascular effects. Non-invasive measures of vascular function can detect preclinical cardiovascular disease and serve as a useful surrogate for early CVD risk. We hypothesized that serum concentrations of PFAs would be associated with noninvasive measures of vascular function, carotid-femoral pulse wave velocity (PWV) and brachial artery reactivity testing (BART), in adults with non-occupational exposure to PFAs. METHODS:We measured serum concentrations of 14 PFAs with hybrid solid-phase extraction and ultrahigh-performance liquid chromatography-tandem mass spectrometry in 94 adult outpatients with no known cardiovascular disease. We collected clinical and demographic data; and measured vascular function, PWV and BART, using standard protocols. We assessed associations of individual PFAs with log-transformed BART and PWV using linear regression. We used weighted quantile sum regression to assess effects of correlated PFA mixtures on BART and PWV. RESULTS:Ten PFAs were measured above the limit of detection in >50% of participants. Each standard deviation increase in concentration of perfluoroheptanoic acid (PFHpA) was associated with 15% decrease in BART (95% CI: -28.5, -0.17). The weighted index of a mixture of PFAs with correlated concentrations was inversely associated with BART: each tertile increase in the weighted PFA mixture was associated with 25% lower BART, with 73% of the effect driven by PFHpA. In contrast, no PFAs or mixtures were associated with PWV. CONCLUSIONS:Serum concentration of PFHpA, a new, short-chain PFA, was associated with impaired vascular function among outpatients without CVD. Our findings support a potential adverse cardiovascular effect of newer, short-chain PFAs.
PMID: 35447152
ISSN: 1096-0953
CID: 5428772

Barriers and Facilitators to the Implementation of a Mobile Insulin Titration Intervention for Patients With Uncontrolled Diabetes: A Qualitative Analysis

Rogers, Erin; Aidasani, Sneha R; Friedes, Rebecca; Hu, Lu; Langford, Aisha T; Moloney, Dana N; Orzeck-Byrnes, Natasha; Sevick, Mary Ann; Levy, Natalie
BACKGROUND:In 2016, a short message service text messaging intervention to titrate insulin in patients with uncontrolled type 2 diabetes was implemented at two health care facilities in New York City. OBJECTIVE:This study aimed to conduct a qualitative evaluation assessing barriers to and the facilitators of the implementation of the Mobile Insulin Titration Intervention (MITI) program into usual care. METHODS:We conducted in-depth interviews with 36 patients enrolled in the MITI program and the staff involved in MITI (n=19) in the two health care systems. Interviews were transcribed and iteratively coded by two study investigators, both inductively and deductively using a codebook guided by the Consolidated Framework for Implementation Research. RESULTS:Multiple facilitator themes emerged: (1) MITI had strong relative advantages to in-person titration, including its convenience and time-saving design, (2) the free cost of MITI was important to the patients, (3) MITI was easy to use and the patients were confident in their ability to use it, (4) MITI was compatible with the patients' home routines and clinic workflow, (5) the patients and staff perceived MITI to have value beyond insulin titration by reminding and motivating the patients to engage in healthy behaviors and providing a source of patient support, and (6) implementation in clinics was made easy by having a strong implementation climate, communication networks to spread information about MITI, and a strong program champion. The barriers identified included the following: (1) language limitations, (2) initial nurse concerns about the scope of practice changes required to deliver MITI, (3) initial provider knowledge gaps about the program, and (4) provider perceptions that MITI might not be appropriate for some patients (eg, older or not tech-savvy). There was also a theme that emerged during the patient and staff interviews of an unmet need for long-term additional diabetes management support among this population, specifically diet, nutrition, and exercise support. CONCLUSIONS:The patients and staff were overwhelmingly supportive of MITI and believed that it had many benefits and that it was compatible with the clinic workflow and patients' lives. Initial implementation efforts should address staff training and nurse concerns. Future research should explore options for integrating additional diabetes support for patients.
PMID: 31368439
ISSN: 2291-5222
CID: 4011252

Aiming for equity: Exploring patient preferences for assistance with social determinant of health (SDOH) barriers in patients with uncontrolled type 2 insulin-dependent diabetes (IDDM) seeking care at a safety-net hospital [Meeting Abstract]

Levy, N K; Park, A; Solis, D; Wang, B; Langford, A; Hu, L; Rogers, E
Background: Health equity can broadly be defined as giving people the opportunities and resources needed to maximize health regardless of socially determined circumstances. SDoH are economic and social conditions that lead to differences in health status. We practice medicine at a mission driven safety-net hospital and provide care to patients with uncontrolled type 2 IDDM. Understanding not only these patients' SDoH barriers, but also their preferences for assistance, is the first step in providing equitable help.
Method(s): We used surveys and interviews to learn about 3 themes: SDoH barriers that impacted the ability to care for one's diabetes, desirable service features of any assistance program, and the types of services patients feel are needed.
Result(s): We learned that 84% of patients had > 1 barrier to health care access, 54% were unable to pay for > 1 essential item when it was needed, 53% reported > 1 barrier in their built environment, 47% reported > 1 issue with health literacy, and 37% shared that they only saw or talked to someone that they cared about or felt close to < 2 times per week. In the process of defining SDoH barriers, we also learned about unhealthy behavior patterns: 69% of patients have inadequate fruit and vegetable consumption, 57% get no leisure-time physical activity, 48% sometimes or often miss a day of checking their blood sugar, 35% sometimes or often miss doses of their medications and 30% are unable to follow up with their doctor in the time frame they are given. Despite their obstacles, patients felt that they didn't need " help". While they did share preferences on desirable service features, they volunteered very little regarding desirable types of services. Their lack of suggestions on service features was a finding in and of itself, warranting further exploration. In the end, we gauged interest in currently available resources at our hospital and in NYC, as well as our team's ideas for potential new programs to tackle some of the unhealthy behavior patterns we learned about (see types of services below). The service features that were a priority for any assistance program were: doctor knows about the program (86%), cost (87%), program is in-person (83%), program sends reminders (74%), program is a group class (74%), program is close to home (70%). In terms of types of services, 70% of patients want to learn about Farmer's markets as a source to eat more produce, 65% want to use the pedometer program we are developing and up to 45% want to use Bellevue's new Diabetes Patient Navigator program for assistance with barriers to health care access, taking diabetes medications, and checking blood sugar.
Conclusion(s): Patients with uncontrolled type 2 IDDM at our safety-net hospital have significant SDoH barriers, multiple service feature preferences, and are interested in programs currently available and under development. Understanding patient preferences for assistance is a key step in creating solutions that provide equity for underserved patients in need
ISSN: 1525-1497
CID: 4053172

Sociodemographic and clinical correlates of key outcomes from a Mobile Insulin Titration Intervention (MITI) for medically underserved patients

Langford, Aisha T; Wang, Binhuan; Orzeck-Byrnes, Natasha A; Aidasani, Sneha R; Hu, Lu; Applegate, Melanie; Moloney, Dana N; Sevick, Mary Ann; Rogers, Erin S; Levy, Natalie K
BACKGROUND:Insulin titration is typically done face-to-face with a clinician; however, this can be a burden for patients due to logistical issues associated with in-person clinical care. The Mobile Insulin Titration Intervention (MITI) used basic cell phone technology including text messages and phone calls to help patients with diabetes find their optimal basal insulin dose (OID). OBJECTIVE:To evaluate sociodemographic and clinical correlates of reaching OID, text message response rate, and days needed to reach OID. METHODS:Primary care providers referred patients to MITI and nurses delivered the program. Three multivariable regression models quantified relationships between various correlates and primary outcomes. RESULTS:The sample included 113 patients from 2 ambulatory clinics, with a mean age of 50 years (SD = 10), 45% female, 79% Hispanic, 43% unemployed, and 46% uninsured. In regression models, baseline fasting blood glucose (FBG) was negatively associated with odds of reaching OID and 100% text responses, and positively associated with days to reach OID, p < .05). CONCLUSIONS:Patients with higher baseline FBG levels were less successful across outcomes and may need additional supports in future mHealth diabetes programs. PRACTICAL IMPLICATIONS/CONCLUSIONS:Basic cell phone technology can be used to adjust patients' insulin remotely, thereby reducing logistical barriers to care.
PMID: 30293934
ISSN: 1873-5134
CID: 3334822