"Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model.

BACKGROUND: Despite decades of evidence demonstrating the efficacy of hypertension care delivery in reducing morbidity and mortality, a majority of hypertension cases remain uncontrolled. There is an urgent need to elucidate and address multilevel facilitators and barriers clinical staff face in delivering evidence-based hypertension care, patients face in accessing it, and clinical systems face in sustaining it. Through a rigorous pre-implementation evaluation, we aimed to identify facilitators and barriers bearing the potential to affect the planned implementation of a multilevel technology-facilitated hypertension management trial across six primary care sites in a large federally qualified health center (FQHC) in New York City. METHODS: During a dedicated pre-implementation period (3-9 months/site, 2021-2022), a capacity assessment was conducted by trained practice facilitators, including (1) online anonymous surveys (n = 124; 70.5% of eligible), (2) hypertension training analytics (n = 69; 94.5% of assigned), and (3) audio-recorded semi-structured interviews (n = 67; 48.6% of eligible) with FQHC leadership and staff. Surveys measured staff sociodemographic characteristics, adaptive reserve, evidence-based practice attitudes, and implementation leadership scores via validated scales. Training analytics, derived from end-of-course quizzes, included mean score and number attempts needed to pass. Interviews assessed staff-reported facilitators and barriers to current hypertension care delivery and uptake; following audio transcription, trained qualitative researchers employed a deductive coding approach, informed by the Consolidated Framework for Implementation Research (CFIR). RESULTS: Most survey respondents reported moderate adaptive reserve (mean = 0.7, range = 0-1), evidence-based practice attitudes (mean = 2.7, range = 0-4), and implementation leadership (mean = 2.5, range = 0-4). Most staff passed training courses on first attempt and demonstrated high scores (means > 80%). Findings from interviews identified potential facilitators and barriers to implementation; specifically, staff reported that complex barriers to hypertension care, control, and clinical communication exist; there is a recognized need to improve hypertension care; in-clinic challenges with digital tool access imposes workflow delays; and despite high patient loads, staff are motivated to provide high-quality cares. CONCLUSIONS: This study serves as one of the first to apply the CFIR to a rigorous pre-implementation evaluation within the understudied context of a FQHC and can serve as a model for similar trials seeking to identify and address contextual factors known to impact implementation success. TRIAL REGISTRATION: ClinicalTrials.gov NCT03713515 , date of registration: October 19, 2018.

Construction of the Digital Health Equity-Focused Implementation Research Conceptual Model - Bridging the Divide Between Equity-focused Digital Health and Implementation Research.

Digital health implementations and investments continue to expand. As the reliance on digital health increases, it is imperative to implement technologies with inclusive and accessible approaches. A conceptual model can be used to guide equity-focused digital health implementations to improve suitability and uptake in diverse populations. The objective of this study is expand an implementation model with recommendations on the equitable implementation of new digital health technologies. The Digital Health Equity-Focused Implementation Research (DH-EquIR) conceptual model was developed based on a rigorous review of digital health implementation and health equity literature. The Equity-Focused Implementation Research for Health Programs (EquIR) model was used as a starting point and merged with digital equity and digital health implementation models. Existing theoretical frameworks and models were appraised as well as individual equity-sensitive implementation studies. Patient and program-related concepts related to digital equity, digital health implementation, and assessment of social/digital determinants of health were included. Sixty-two articles were analyzed to inform the adaption of the EquIR model for digital health. These articles included digital health equity models and frameworks, digital health implementation models and frameworks, research articles, guidelines, and concept analyses. Concepts were organized into EquIR conceptual groupings, including population health status, planning the program, designing the program, implementing the program, and equity-focused implementation outcomes. The adapted DH-EquIR conceptual model diagram was created as well as detailed tables displaying related equity concepts, evidence gaps in source articles, and analysis of existing equity-related models and tools. The DH-EquIR model serves to guide digital health developers and implementation specialists to promote the inclusion of health-equity planning in every phase of implementation. In addition, it can assist researchers and product developers to avoid repeating the mistakes that have led to inequities in the implementation of digital health across populations.

Application of the FRAME-IS to a multifaceted implementation strategy.

BACKGROUND: Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation. In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). METHODS: Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. RESULTS: We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. CONCLUSION: With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.

Goal setting among older adults starting mobile health cardiac rehabilitation in the RESILIENT trial.

BACKGROUND: There is growing recognition that healthcare should align with individuals' health priorities; however, these priorities remain undefined, especially among older adults. The Rehabilitation Using Mobile Health for Older Adults with Ischemic Heart Disease in the Home Setting (RESILIENT) trial, designed to test the efficacy of mobile health cardiac rehabilitation (mHealth-CR) in an older cohort, also measures the attainment of participant-defined health outcome goals as a prespecified secondary endpoint. This study aimed to characterize the health priorities of older adults with ischemic heart disease (IHD) using goal attainment scaling-a technique for measuring individualized goal achievement-in a sample of 100 RESILIENT participants. METHODS: The ongoing RESILIENT trial randomizes patients aged ≥65 years with IHD (defined as hospitalization for acute coronary syndrome and/or coronary revascularization), to receive mHealth-CR or usual care. For the current study, we qualitatively coded baseline goal attainment scales from randomly selected batches of 20 participants to identify participants' cardiac rehabilitation outcome goals and their perceptions of barriers and action plans for goal attainment. We used a deductive framework (i.e., 4 value categories from Patient Priorities Care) and inductive approaches to code and analyze interviews until thematic saturation. RESULTS: This sample of 100 older adults set diverse health outcome goals. Most (54.6%) prioritized physical activity, fewer (17.1%) identified symptom management, fewer still (13.7%) prioritized health metrics, mostly comprised of weight loss goals (10.3%), and the fewest (<4%) were related to clinical metrics such as reducing cholesterol or preventing hospital readmission. Participants anticipated extrinsic (access to places to exercise, time) and intrinsic (non-cardiac pain, motivation) barriers. Action plans detailed strategies for exercise, motivation, accountability, and overcoming time constraints. CONCLUSIONS: Using goal attainment scaling, we elicited specific and measurable goals among older adults with IHD beginning cardiac rehabilitation. Priorities were predominantly functional, diverging from clinical metrics emphasized by clinicians and healthcare systems.

Application of the FRAME-IS to a Multifaceted Implementation Strategy.

Background: Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation (PF). In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). Methods: Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. Results: We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. Conclusion: With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. Trial Registration: clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.

Structural racism and health: Assessing the mediating role of community mental distress and health care access in the association between mass incarceration and adverse birth outcomes.

Research has linked spatial concentrations of incarceration with racial disparities in adverse birth outcomes. However, little is known about the specific mechanisms of this association. This represents an important knowledge gap in terms of intervention. We theorize two pathways that may account for the association between county-level prison rates and adverse birth outcomes: (1) community-level mental distress and (2) reduced health care access. Examining these mechanisms, we conducted a cross-sectional study of county-level prison rates, community-level mental distress, health insurance, availability of primary care physicians (PCP) and mental health providers (MHP), and adverse birth outcomes (preterm birth, low birth weight, infant mortality). Our data set included 475 counties and represented 2,677,840 live U.S. births in 2016. Main analyses involved between 170 and 326 counties. All data came from publicly available sources, including the U.S. Census and the Centers for Disease Control and Prevention. Descriptive and regression results confirmed the link between prison rates and adverse birth outcomes and highlighted Black-White inequities in this association. Further, bootstrap mediation analyses indicated that the impact of spatially concentrated prison rates on preterm birth was mediated by PCP, MHP, community-level mental distress, and health insurance in both crude and adjusted models. Community-level mental distress and health insurance (but not PCP or MHP) similarly mediated low birthweight in both models. Mediators were less stable in the effect on infant mortality with only MHP mediating consistently across models. We conclude that mass incarceration, health care access, and community mental distress represent actionable and urgent targets for structural-, community-, and individual-level interventions targeting population inequities in birth outcomes.

Characteristics of programmes designed to link community-dwelling older adults in high-income countries from community to clinical sectors: a scoping review protocol.

INTRODUCTION: Research on effectively navigating older adults into primary care is urgently needed. Community-clinic linkage models (CCLMs) aim to improve population health by linking the health and community sectors in order to improve patients' access to healthcare and, ultimately, population health. However, research on community-based points of entry linking adults with untreated medical needs into the healthcare sector is nascent. CCLMs implemented for the general adult population are not necessarily accessible to older adults. Given the recency of the CCLM literature and the seeming rarity of CCLM interventions designed for older adults, it is appropriate to employ scoping review methodology in order to generate a comprehensive review of the available information on this topic. This protocol will inform a scoping review that reviews characteristics of community-based programmes that link older adults with the healthcare sector. METHODS AND ANALYSIS: The present protocol was developed as per JBI Evidence Synthesis best practice guidance and reporting items for the development of scoping review protocols. The proposed scoping review will follow Levac and colleagues' update to Arksey and O'Malley's scoping review methodology. Healthcare access at the system and individual levels will be operationalised in data extraction and analysis in accordance with Levesque and colleagues' Conceptual Framework of Access to Health. The protocol complies with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. Beginning in August 2023 or later, citation databases (AgeLine (Ebsco); CINAHL Complete; MEDLINE (PubMed); Scopus Advanced (Elsevier); Social Services Abstracts (ProQuest); Web of Science Core Collection (Clarivate)) and grey literature (Google; American Public Health Association Annual Meeting Conference Proceedings; SIREN Evidence & Resource Library) will be searched. ETHICS AND DISSEMINATION: The authors plan to disseminate their findings in conference proceedings and publication in a peer-reviewed journal and deposit extracted data in the Figshare depository. The study does not require Institutional Review Board approval. REGISTRATION DETAILS: Protocol registered in Open Science Framework (DOI https://doi.org/10.17605/OSF.IO/2EF9D).

Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes.

BACKGROUND: Mobile health (mHealth) tools are used to collect data on patient-reported outcomes (PROs) and facilitate the assessment of patients' self-management behaviors outside the clinic environment. Despite the high availability of mHealth diabetes tools, there is a lack of understanding regarding the underlying reasons why these mHealth PRO tools succeed or fail in terms of changing patients' self-management behaviors. OBJECTIVE: This study aims to identify the factors that drive engagement with an mHealth PRO tool and facilitate patients' adoption of self-management behaviors, as well as elicit suggestions for improvement. METHODS: This qualitative study was conducted within the context of a randomized controlled trial designed to evaluate the efficacy of an mHealth PRO tool (known as i-Matter) versus usual care regarding reduction in glycated hemoglobin (HbA1c) levels and adherence to self-management behaviors at 12 months among patients with uncontrolled type 2 diabetes. Patients randomized to i-Matter participated in semistructured interviews about their experiences at the 3-, 6-, 9-, and 12-month study visits. A qualitative analysis of the interviews was conducted by 2 experienced qualitative researchers using conventional qualitative content analysis. RESULTS: The sample comprised 71 patients, of whom 67 (94%) completed at least one interview (n=48, 72% female patients; n=25, 37% identified as African American or Black; mean age 56.65 [SD 9.79] years). We identified 4 overarching themes and 6 subthemes. Theme 1 showed that the patients' reasons for engagement with i-Matter were multifactorial. Patients were driven by internal motivating factors that bolstered their engagement and helped them feel accountable for their diabetes (subtheme 1) and external motivating factors that helped to serve as reminders to be consistent with their self-management behaviors (subtheme 2). Theme 2 revealed that the use of i-Matter changed patients' attitudes toward their disease and their health behaviors in 2 ways: patients developed more positive attitudes about their condition and their ability to effectively self-manage it (subtheme 3), and they also developed a better awareness of their current behaviors, which motivated them to adopt healthier lifestyle behaviors (subtheme 4). Theme 3 showed that patients felt more committed to their health as a result of using i-Matter. Theme 4 highlighted the limitations of i-Matter, which included its technical design (subtheme 5) and the need for more resources to support the PRO data collected and shared through the tool (subtheme 6). CONCLUSIONS: This study isolated internal and external factors that prompted patients to change their views about their diabetes, become more engaged with the intervention and their health, and adopt healthy behaviors. These behavioral mechanisms provide important insights to drive future development of mHealth interventions that could lead to sustained behavior change.

Frequency and nature of discussing social influences on health in urban safety-net clinics: A qualitative analysis.

OBJECTIVE: Chronic social isolation is a risk factor for all-cause mortality and disease progression, but is not routinely screened for in clinical settings. This study analyzed provider-patient communication patterns about social influences during primary care encounters, to identify opportunities to screen for objective or perceived social isolation. METHODS: Content analysis was conducted on transcripts of 97 audiotaped, English-speaking patient encounters with 27 primary care providers at 3 safety-net primary care centers in New York City. Conversations were first coded for specific social isolation screening, then more broadly to quantify and qualify how social influences were discussed in relation to health. RESULTS: Transcripts included no explicit examples of social isolation screening. Social influences on health were discussed meaningfully in only 28 % of transcripts, compared to medication adherence (93 %) and diet (64 %). Patients initiated conversations about social influences on health twice as often as providers, however providers did not acknowledge 67% of these prompts. CONCLUSION: Social influences on health, including social isolation, were uncommonly discussed in this sample of primary care visits. When social influences were discussed meaningfully, providers utilized relationship-centered communication strategies. PRACTICE IMPLICATIONS: Strategic conversations about social influences, even when brief and informal, can effectively screen patients for social isolation.

Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Low medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can be used for interventions at the point of care. We developed a multicomponent intervention that uses linked EHR and pharmacy data to automatically identify patients with elevated blood pressure and low medication adherence. The intervention then combines team-based care with EHR-based workflows to address medication nonadherence. OBJECTIVE: This study aims to describe the design of the Leveraging EHR Technology and Team Care to Address Medication Adherence (TEAMLET) trial, which tests the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence among patients with hypertension. METHODS: TEAMLET is a pragmatic, cluster randomized controlled trial in which 10 primary care practices will be randomized 1:1 to the multicomponent intervention or usual care. We will include all patients with hypertension and low medication adherence who are seen at enrolled practices. The primary outcome is medication adherence, as measured by the proportion of days covered, and the secondary outcome is clinic systolic blood pressure. We will also assess intervention implementation, including adoption, acceptability, fidelity, cost, and sustainability. RESULTS: As of May 2023, we have randomized 10 primary care practices into the study, with 5 practices assigned to each arm of the trial. The enrollment for the study commenced on October 5, 2022, and the trial is currently ongoing. We anticipate patient recruitment to go through the fall of 2023 and the primary outcomes to be assessed in the fall of 2024. CONCLUSIONS: The TEAMLET trial will evaluate the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence. If successful, the intervention could offer a scalable approach to address inadequate blood pressure control among millions of patients with hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47930.

Operational Implementation of Remote Patient Monitoring Within a Large Ambulatory Health System: Multimethod Qualitative Case Study.

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.

Roadmap for embedding health equity research into learning health systems.

BACKGROUND: Achieving health equity is vital to fulfil the quadruple aim for optimal healthcare system performance. Traditionally, academic medicine and healthcare systems have focused their efforts on addressing health inequities with an emphasis on improving workforce diversity. Although this approach is an important requisite, a diverse workforce alone is not sufficient; rather holistic health equity should be established as the anchoring principal mission of all academic medical centres, residing at the intersection of clinical care, education, research and community. METHODS: NYU Langone Health (NYULH) has embarked on significant institutional changes to position itself as an equity-focused learning health system. One-way NYULH accomplishes this is through the establishment of a health equity research roadmap, which serves as the organising framework through which we conduct embedded pragmatic research in our healthcare delivery system to target and eliminate health inequities across our tripartite mission of patient care, medical education and research. RESULTS: This article outlines each of the six elements of the NYULH roadmap. These elements include: (1) developing processes for collecting accurate disaggregate data on race, ethnicity and language, sexual orientation and gender identity and disability; (2) using a data-driven approach to identify health equity gaps; (3) creating performance and metric-based quality improvement goals to measure progress toward elimination of health equity gaps; (4) investigating the root cause of the identified health equity gap; (5) developing and evaluating evidence-based solutions to address and resolve the inequities; and (6) continuous monitoring and feedback for system improvements. CONCLUSION: Application of each element of the roadmap can provide a model for how academic medical centres can use pragmatic research to embed a culture of health equity into their health system.

Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review.

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.

A randomized clinical trial comparing low-fat with precision nutrition-based diets for weight loss: impact on glycemic variability and HbA1c.

BACKGROUND: Recent studies have demonstrated considerable interindividual variability in postprandial glucose response (PPGR) to the same foods, suggesting the need for more precise methods for predicting and controlling PPGR. In the Personal Nutrition Project, the investigators tested a precision nutrition algorithm for predicting an individual's PPGR. OBJECTIVE: This study aimed to compare changes in glycemic variability (GV) and HbA1c in 2 calorie-restricted weight loss diets in adults with prediabetes or moderately controlled type 2 diabetes (T2D), which were tertiary outcomes of the Personal Diet Study. METHODS: The Personal Diet Study was a randomized clinical trial to compare a 1-size-fits-all low-fat diet (hereafter, standardized) with a personalized diet (hereafter, personalized). Both groups received behavioral weight loss counseling and were instructed to self-monitor diets using a smartphone application. The personalized arm received personalized feedback through the application to reduce their PPGR. Continuous glucose monitoring (CGM) data were collected at baseline, 3 mo and 6 mo. Changes in mean amplitude of glycemic excursions (MAGEs) and HbA1c at 6 mo were assessed. We performed an intention-to-treat analysis using linear mixed regressions. RESULTS: We included 156 participants [66.5% women, 55.7% White, 24.1% Black, mean age 59.1 y (standard deviation (SD) = 10.7 y)] in these analyses (standardized = 75, personalized = 81). MAGE decreased by 0.83 mg/dL per month for standardized (95% CI: 0.21, 1.46 mg/dL; P = 0.009) and 0.79 mg/dL per month for personalized (95% CI: 0.19, 1.39 mg/dL; P = 0.010) diet, with no between-group differences (P = 0.92). Trends were similar for HbA1c values. CONCLUSIONS: Personalized diet did not result in an increased reduction in GV or HbA1c in patients with prediabetes and moderately controlled T2D, compared with a standardized diet. Additional subgroup analyses may help to identify patients who are more likely to benefit from this personalized intervention. This trial was registered at clinicaltrials.gov as NCT03336411.

Self-reported adherence and reasons for nonadherence among patients with low proportion of days covered for antihypertension medications.

BACKGROUND: Incorporation of pharmacy fill data into the electronic health record has enabled calculations of medication adherence, as measured by proportion of days covered (PDC), to be displayed to clinicians. Although PDC values help identify patients who may be nonadherent to their medications, it does not provide information on the reasons for medication-taking behaviors. OBJECTIVE: To characterize self-reported adherence status to antihypertensive medications among patients with low refill medication adherence. Our secondary objective was to identify the most common reasons for nonadherence and examine the patient sociodemographic characteristics associated with these barriers. METHODS: Participants were adult patients seen in primary care clinics of a large, urban health system and on antihypertensive therapy with a PDC of less than 80% based on 6-month linked electronic health record-pharmacy fill data. We administered a validated medication adherence screener and a survey assessing reasons for antihypertensive medication nonadherence. We used descriptive statistics to characterize these data and logistic and Poisson regression models to assess the relationship between sociodemographic characteristics and adherence barriers. RESULTS: The survey was completed by 242 patients (57% female; 61.2% White; 79.8% not Latino/a or Hispanic). Of these patients, 45% reported missing doses of their medications in the last 7 days. In addition, 48% endorsed having at least 1 barrier to adherence and 38.4% endorsed 2 or more barriers. The most common barriers were being busy and having difficulty remembering to take medications. Compared with White participants, Black participants (incident rate ratio = 2.49; 95% CI = 1.93-3.22) and participants of other races (incident rate ratio = 2.16; 95% CI = 1.62-2.89) experienced a greater number of barriers. CONCLUSIONS: Nearly half of patients with low PDC reported nonadherence in the prior week, suggesting PDC can be used as a screening tool. Augmenting PDC with brief self-report tools can provide insights into the reasons for nonadherence. DISCLOSURES: Dr Kharmats, Ms Martinez, Dr Belli, Ms Zhao, Dr Mann, Dr Schoenthaler, and Dr Blecker received grants from the National Institute of Health/National Heart, Lung, Blood Institute. Dr Voils holds a license by Duke University for the DOSE-Nonadherence measure and is a consultant for New York University Grossman School of Medicine. This research was supported by the NIH (R01HL156355). Dr Kharmats received a postdoctoral training grant from the National Institutes of Health (5T32HL129953-04). Dr Voils was supported by a Research Career Scientist award from the Health Services Research & Development Service of the Department of Veterans Affairs (RCS 14-443). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the United States Government.

Barbershop-Facilitated Community-to-Clinic Linkage Implementation Program: Rationale and Protocol for a Novel Program to Prevent Hypertension Among Black Men.

BACKGROUND: Black men in the United States have higher hypertension (HTN) prevalence than other groups, largely due to adverse social determinants of health, including poor healthcare access. The Community-to-Clinic Linkage Implementation Program (CLIP) is effective for HTN screening in Black-owned barbershops. However, its effect on HTN prevention among Black men is untested. Here, we describe the rationale and study protocol for the development and testing of a barbershop facilitation (BF) strategy, with trained Community Health Workers, to implement and scale CLIP for HTN prevention in Black men. METHODS: The study is part of the American Heart Association (AHA)-funded RESTORE (Addressing Social Determinants to Prevent Hypertension) Health Equity Research Network. The study is tri-phasic: (i) pre-implementation-qualitative examination of factors affecting adoption of CLIP and development of BF strategy, (ii) implementation-cluster randomized control trial to test the effectiveness of CLIP with and without BF. We will partner with 20 barbershops and enroll 420 Black men with elevated blood pressure (BP)/Stage 1 HTN (2017 ACC/AHA HTN guidelines). Outcomes include reduction in BP, rate of CLIP adoption and linkage to care, and incidence of Stage 2 HTN. The study time frame is 12 months, (iii) post-implementation-we will evaluate program sustainability (6 months post-trial conclusion) and cost-effectiveness (up to 10 years). CONCLUSIONS: This study harnesses community-based resources to address HTN prevention in Black men, who are more adversely impacted by HTN than other groups. It has major policy relevance for health departments and other stakeholders to address HTN prevention in Black communities. CLINICALTRIALS.GOV IDENTIFIER: NCT05447962.

Assessment of Patient Education Delivered at Time of Hospital Discharge.

Importance: Patient education at time of hospital discharge is critical for smooth transitions of care; however, empirical data regarding discharge communication are limited. Objective: To describe whether key communication domains (medication changes, follow-up appointments, disease self-management, red flags, question solicitation, and teach-back) were addressed at the bedside on the day of hospital discharge, by whom, and for how long. Design, Setting, and Participants: This quality improvement study was conducted from September 2018 through October 2019 at inpatient medicine floors in 2 urban, tertiary-care teaching hospitals and purposefully sampled patients designated as "discharge before noon." Data analysis was performed from September 2018 to May 2020. Exposures: A trained bedside observer documented all content and duration of staff communication with a single enrolled patient from 7 am until discharge. Main Outcomes and Measures: Presence of the key communication domains, role of team members, and amount of time spent at the bedside. Results: Discharge days for 33 patients were observed. Patients had a mean (SD) age of 63 (18) years; 14 (42%) identified as White, 15 (45%) were female, and 6 (18%) had a preferred language of Spanish. Thirty patients were discharged with at least 1 medication change. Of these patients, 8 (27%) received no verbal instruction on the change, while 16 of 30 (53%) were informed but not told the purpose of the changes. About half of the patients (15 of 31, 48%) were not told the reason for follow-up appointments, and 18 of 33 (55%) were not given instructions on posthospital disease self-management. Most patients (27 of 33, 81%) did not receive guidance on red-flag signs. While over half of the patients (19 of 33, 58%) were asked if they had any questions, only 1 patient was asked to teach back his understanding of the discharge plan. Median (IQR) total time spent with patients on the day of discharge by interns, senior residents, attending physicians, and nurses was 4.0 (0.75-6.0), 1.0 (0-2.0), 3.0 (0.5-7.0), and 22.5 (15.5-30.0) minutes, respectively. Most of the time was spent discussing logistics rather than discharge education. Conclusions and Relevance: In this quality improvement study, patients infrequently received discharge education in key communication domains, potentially leaving gaps in patient knowledge. Interventions to improve the hospital discharge process should address the content, method of delivery, and transparency among team members regarding patient education.

Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial.

BACKGROUND: Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. mHealth strategies including short messaging service (SMS) texting have been feasible and acceptable, and improved control of chronic diseases including DM. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. We propose an SMS strategy could offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. METHODS AND ANALYSIS: This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n = 100). Outcomes will be measured at 0, 3, 6, &9 months. AIM 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH (n = 20) and providers (n = 10). DISCUSSION: DM is not well-addressed among PEH. SMS strategies for DM have never been tested in PEH despite evidence of their effectiveness and access to mobile phones among PEH. Results from this study will provide important empirical data to inform evidence-based strategies to avert personal suffering and significant costs. It will have broader policy implications in control of DM and other chronic diseases.

How Does Living in Temporary Accommodation and the COVID-19 Pandemic Impact under 5s' Healthcare Access and Health Outcomes? A Qualitative Study of Key Professionals in a Socially and Ethnically Diverse and Deprived Area of London.

Background: Children < 5 years living in temporary accommodation (U5TA) are vulnerable to poor health outcomes. Few qualitative studies have examined service provider perspectives in family homelessness; none have focused on U5TA with a cross-sector approach. This study explored professionals' perspectives of the barriers and facilitators, including pandemic-related challenges, experienced by U5TA in accessing healthcare and optimising health outcomes, and their experiences in delivering services. Methods: Sixteen semi-structured online interviews were conducted. Professionals working in Newham (London) with U5TA families were recruited from non-profit organisations, the health sector, and Local Authority. A thematic analysis was conducted. Findings: Professionals described barriers including poor parental mental health; unsuitable housing; no social support; mistrust of services; immigration administration; and financial insecurity. Digital poverty, language discordance, and the inability to register and track U5TA made them even less visible to services. Professionals tried to mitigate barriers with improved communication, and through community facilitators. Adverse pandemic effects on U5TA health included delay and regression in developmental milestones and behaviours. In-person services were reduced, exacerbating pre-existing barriers. Interpretation: COVID-19 further reduced the ability of professionals to deliver care to U5TA and significantly impacted the lives of U5TA with potential life-long risks. Innovative and tailored cross-sector strategies are needed, including co-production of public health services and policies focusing on early development, mental health support, employment training, and opportunities for parents/carers.