Faculty Bibliography

Background: Remote patient monitoring (RPM) technologies can support patients living with chronic conditions through self-monitoring of physiological measures and enhance clinicians"™ diagnostic and treatment decisions. However, to date, large-scale pragmatic RPM implementation within health systems has been limited, and understanding of the impacts of RPM technologies on clinical workflows and care experience is lacking. Objective: In this study, we evaluate the early implementation of operational RPM initiatives for chronic disease management within the ambulatory network of an academic medical center in New York City, focusing on the experiences of "early adopter" clinicians and patients. Methods: Using a multimethod qualitative approach, we conducted (1) interviews with 13 clinicians across 9 specialties considered as early adopters and supporters of RPM and (2) speculative design sessions exploring the future of RPM in clinical care with 21 patients and patient representatives, to better understand experiences, preferences, and expectations of pragmatic RPM use for health care delivery. Results: We identified themes relevant to RPM implementation within the following areas: (1) data collection and practices, including impacts of taking real-world measures and issues of data sharing, security, and privacy; (2) proactive and preventive care, including proactive and preventive monitoring, and proactive interventions and support; and (3) health disparities and equity, including tailored and flexible care and implicit bias. We also identified evidence for mitigation and support to address challenges in each of these areas. Conclusions: This study highlights the unique contexts, perceptions, and challenges regarding the deployment of RPM in clinical practice, including its potential implications for clinical workflows and work experiences. Based on these findings, we offer implementation and design recommendations for health systems interested in deploying RPM-enabled health care.

Academic and community investigators conducting community-engaged research (CEnR) are often met with challenges when seeking Institutional Review Board (IRB) approval. This scoping review aims to identify challenges and recommendations for CEnR investigators and community partners working with IRBs. Peer-reviewed articles that reported on CEnR, specified study-related challenges, and lessons learned for working with IRBs and conducted in the United States were included for review. Fifteen studies met the criteria and were extracted for this review. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners. Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigator to satisfy IRB concerns. Findings from our study suggest that IRBs can benefit from more training in CEnR requirements and methodologies.

PURPOSE OF REVIEW/OBJECTIVE:To identify intervention strategies that were effective in promoting medication adherence and HTN control among racial/ethnic minority groups in the US. RECENT FINDINGS/RESULTS:Twelve articles were included in this review and 4 categories of intervention strategies were identified as counseling by trained personnel, mHealth tools, mHealth tools in combination with counseling by trained personnel, and quality improvement. The findings show that interventions delivered by trained personnel are effective in lowering BP and improving medication adherence, particularly for those delivered by health educators, CHWs, medical assistants, and pharmacists. Additionally, the combination of mHealth tools with counseling by trained personnel has the potential to be more effective than either mHealth or counseling alone and report beneficial effects on medication adherence and BP control. This review provides potential next steps for future research to examine the effectiveness of mHealth interventions in combination with support from trained health personnel and its effects on racial disparities in HTN outcomes.

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.

BACKGROUND:Patient-reported outcomes (PROs) capture patients' views on their health conditions and its management, and are increasingly used in clinical trials, including those targeting type 2 diabetes (T2D). Mobile health (mHealth) tools offer novel solutions for collecting PRO data in real time. Although patients are at the center of any PRO-based intervention, few studies have examined user engagement with PRO mHealth tools. OBJECTIVE:This study aimed to evaluate user engagement with a PRO mHealth tool for T2D management, identify patterns of user engagement and similarities and differences between the patients, and identify the characteristics of patients who are likely to drop out or be less engaged with a PRO mHealth tool. METHODS:We extracted user engagement data from an ongoing clinical trial that tested the efficacy of a PRO mHealth tool designed to improve hemoglobin A1c levels in patients with uncontrolled T2D. To date, 61 patients have been randomized to the intervention, where they are sent 6 PRO text messages a day that are relevant to T2D self-management (healthy eating and medication adherence) over the 12-month study. To analyze user engagement, we first compared the response rate (RR) and response time between patients who completed the 12-month intervention and those who dropped out early (noncompleters). Next, we leveraged latent class trajectory modeling to classify patients from the completer group into 3 subgroups based on similarity in the longitudinal engagement data. Finally, we investigated the differences between the subgroups of completers from various cross-sections (time of the day and day of the week) and PRO types. We also explored the patient demographics and their distribution among the subgroups. RESULTS:Overall, 19 noncompleters had a lower RR to PRO questions and took longer to respond to PRO questions than 42 completers. Among completers, the longitudinal RRs demonstrated differences in engagement patterns over time. The completers with the lowest engagement showed peak engagement during month 5, almost at the midstage of the program. The remaining subgroups showed peak engagement at the beginning of the intervention, followed by either a steady decline or sustained high engagement. Comparisons of the demographic characteristics showed significant differences between the high engaged and low engaged subgroups. The high engaged completers were predominantly older, of Hispanic descent, bilingual, and had a graduate degree. In comparison, the low engaged subgroup was composed mostly of African American patients who reported the lowest annual income, with one of every 3 patients earning less than US $20,000 annually. CONCLUSIONS:There are discernible engagement phenotypes based on individual PRO responses, and their patterns vary in the timing of peak engagement and demographics. Future studies could use these findings to predict engagement categories and tailor interventions to promote longitudinal engagement. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov NCT03652389; https://clinicaltrials.gov/ct2/show/NCT03652389. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:RR2-10.2196/18554.

BACKGROUND:Children younger than 5 years living in temporary accommodation due to homelessness (U5TA) are extremely vulnerable to the effects of the COVID-19 pandemic. Few qualitative studies have examined provider perspectives in family homelessness, but none focused on U5TA specifically. We aimed to qualitatively explore professionals' perspectives of pandemic-related challenges and barriers experienced by U5TA in accessing health care and optimising health outcomes, and their experiences of delivering U5TA services. METHODS:16 semi-structured interviews were done online. Professionals working in the London Borough of Newham with U5TA families were purposively sampled and recruited from non-profit organisations, the health sector, and local authority. A thematic codebook approach was used to analyse the data combining inductive and deductive codes using an adapted socioecological model as a guiding theoretical framework. FINDINGS:Two non-profit organisation professionals, seven health visitors, one GP, therapist, dietician, nurse, public health consultant, and two social workers from the local authority's No Recourse to Public Funds team described adverse pandemic effects on U5TA health: delay and regression in developmental milestones and behaviours-eg, toileting, feeding skills, emotional regulation, and social-communication skills. Pre-existing systemic barriers were exacerbated during the pandemic when the reduction of in-person services with professionals necessitated remote delivery of health and social care services. Differential effects of digital poverty, language discordance, and inability to register and track U5TA rendered this population invisible to services. Professionals highly agreed that barriers to optimal health outcomes and service access included poor mental health, unsuitable housing, no social support, mistrust of mainstream services, immigration administration, financial insecurity, and loss of informal jobs among U5TA families. Professionals sometimes mitigated these barriers with good communication skills, developing trusting relations, and through community facilitators. INTERPRETATION:COVID-19 widened health inequalities and inequities, substantially affecting the lives of U5TA and ability of professionals to deliver quality care to U5TA. Innovative and tailored cross-sector strategies, including co-production of public health services, are required. Policies and services urgently need to focus on early development, mental health support, employment training, and opportunities for parents and carers, plus unambiguous definitions of what is deemed suitable accommodation and actionable planned steps to ensure enforcement. FUNDING:None.

BACKGROUND:Hypertension (HTN) control among Blacks in the USA has become a major public health challenge. Barriers to HTN control exist at multiple levels including patient, physician, and the health system. Patients also encounter significant community-level barriers, such as poor linkage to social services that impact health (unstable housing, food access, transportation). We describe a multi-component needs assessment to inform the development, implementation, and evaluation of a program to improve HTN management within a large healthcare system in New York City (NYC). METHODS:Guided by the Community-Based Participatory Research (CBPR) and Consolidated Framework for Implementation Research (CFIR) frameworks, data will be collected from four main sources: (1) quantitative surveys with health systems leadership, providers, and staff and with community-based organizations (CBOs) and faith-based organizations (FBOs); (2) qualitative interviews and focus groups with health systems leadership, providers, and staff and with CBOs and FBOs; (3) NYC Community Health Survey (CHS); and (4) New York University (NYU) Health system Epic Electronic Health Record (EHR) system. The data sources will allow for triangulation and synthesis of findings. DISCUSSION/CONCLUSIONS:Findings from this comprehensive needs assessment will inform the development of a clinic-community-based practice facilitation program utilizing three multi-level evidence-based interventions (nurse case management, remote blood pressure (BP) monitoring, and social determinants of health (SDoH) support) integrated as a community-clinic linkage model for improved HTN control in Black patients. Integration of stakeholders' priorities, perspectives, and practices into the development of the program will improve adoption, sustainability, and the potential for scale-up. TRIAL REGISTRATION/BACKGROUND:NCT05208450; registered on January 26, 2022.

Importance:Interindividual variability in postprandial glycemic response (PPGR) to the same foods may explain why low glycemic index or load and low-carbohydrate diet interventions have mixed weight loss outcomes. A precision nutrition approach that estimates personalized PPGR to specific foods may be more efficacious for weight loss. Objective:To compare a standardized low-fat vs a personalized diet regarding percentage of weight loss in adults with abnormal glucose metabolism and obesity. Design, Setting, and Participants:The Personal Diet Study was a single-center, population-based, 6-month randomized clinical trial with measurements at baseline (0 months) and 3 and 6 months conducted from February 12, 2018, to October 28, 2021. A total of 269 adults aged 18 to 80 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) ranging from 27 to 50 and a hemoglobin A1c level ranging from 5.7% to 8.0% were recruited. Individuals were excluded if receiving medications other than metformin or with evidence of kidney disease, assessed as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation, to avoid recruiting patients with advanced type 2 diabetes. Interventions:Participants were randomized to either a low-fat diet (<25% of energy intake; standardized group) or a personalized diet that estimates PPGR to foods using a machine learning algorithm (personalized group). Participants in both groups received a total of 14 behavioral counseling sessions and self-monitored dietary intake. In addition, the participants in the personalized group received color-coded meal scores on estimated PPGR delivered via a mobile app. Main Outcomes and Measures:The primary outcome was the percentage of weight loss from baseline to 6 months. Secondary outcomes included changes in body composition (fat mass, fat-free mass, and percentage of body weight), resting energy expenditure, and adaptive thermogenesis. Data were collected at baseline and 3 and 6 months. Analysis was based on intention to treat using linear mixed modeling. Results:Of a total of 204 adults randomized, 199 (102 in the personalized group vs 97 in the standardized group) contributed data (mean [SD] age, 58 [11] years; 133 women [66.8%]; mean [SD] body mass index, 33.9 [4.8]). Weight change at 6 months was -4.31% (95% CI, -5.37% to -3.24%) for the standardized group and -3.26% (95% CI, -4.25% to -2.26%) for the personalized group, which was not significantly different (difference between groups, 1.05% [95% CI, -0.40% to 2.50%]; P = .16). There were no between-group differences in body composition and adaptive thermogenesis; however, the change in resting energy expenditure was significantly greater in the standardized group from 0 to 6 months (difference between groups, 92.3 [95% CI, 0.9-183.8] kcal/d; P = .05). Conclusions and Relevance:A personalized diet targeting a reduction in PPGR did not result in greater weight loss compared with a low-fat diet at 6 months. Future studies should assess methods of increasing dietary self-monitoring adherence and intervention exposure. Trial Registration:ClinicalTrials.gov Identifier: NCT03336411.

INTRODUCTION/BACKGROUND:Research has focused on developing methods to facilitate screening and tracking data on social risk factors in healthcare settings. Less is known about the multiple factors that shape patients' acceptance of healthcare-based social risk programs. This qualitative study sought to elucidate the multilevel (individual, interpersonal, family/community, system, policy) factors that influence patients' acceptance of a healthcare-based social risk program within a Federally Qualified Health Center in New York City. METHODS:Participants included 5 patients receiving care at the Federally Qualified Health Center who screened positive for social risks, 4 nurses who are responsible for conducting social risk screenings, and 5 Family Support Services counselors who conduct outreach to patients who screened positive. Interviews were conducted from March to June 2021 and analyzed from July to September 2021 using the constant comparative method. RESULTS:Analyses of the transcripts identified the following 3 themes: (1) Patients appreciated being asked about social risk factors, but there was a mismatch between their understanding of the screening process, their desire for assistance, and the support received. Although nurses and counselors described relationship-centered approaches to involve patients in the process, patients reported feeling initial discomfort and confusion; (2) Multilevel barriers inhibit patients' acceptance of assistance; and (3) Patient trust in the physician and healthcare organization serves as facilitators to acceptance. CONCLUSIONS:Patients' views about the purpose of a healthcare-based social risk program differed from nurses' and counselors' perspectives of the process. Although patients face multilevel challenges, strong trust in the physician and Family Health Centers served as facilitators to accepting healthcare-based assistance.

Structural racism represents a key determinant of the racial health disparities that has characterized the U.S. population throughout its existence. While this reality has recently begun to gain increasing acknowledgment and acceptance within the health sciences, there are still considerable challenges related to defining the concept of structural racism and operationalizing it in empirical study. In this paper, building on the existing evidence base, we propose a comprehensive framework that centers structural racism in terms of its historical roots and continued manifestation in most domains of society, and offer solutions for the study of this phenomenon and the pathways that connect it to population-level health disparities. We showcase our framework by applying it to the known link between spatial and racialized clustering of incarceration - a previously cited representation of structural racism - and disparities in adverse birth outcomes. Through this process we hypothesize pathways that focus on social cohesion and community-level chronic stress, community crime and police victimization, as well as infrastructural community disinvestment. First, we contextualize these mechanisms within the relevant extant literature. Then, we make recommendations for future empirical pathway analyses. Finally, we identify key areas for policy, community, and individual-level interventions that target the impact of concentrated incarceration on birth outcomes among Black people in the U.S.