Background This paper describes an innovative cluster randomized controlled trial design to evaluate the comparative effectiveness of two approaches to preventing significant destabilization, leading to unplanned hospitalization and increased disability for patients with high comorbidity, that is, multiple chronic diseases defined by an enhanced Charlson Comorbidity Index ≥4. Methods A total of 1974 patients were randomized in four waves at each of the sixteen Federally Qualified Health Centers (FQHCs) in four health systems —two in New York and two in Chicago.The two interventions compared 1) Patient-Centered Medical Home (PCMH) as implemented by the FQHCs (usual care control); or 2) PCMH plus a coaching intervention delivered by Health Coaches (experimental) helping patients identify life goals to encourage self-management enhanced by a positive affect/self-affirmation strategy.The two primary patient-centered clinical outcomes are 1) Unplanned hospitalizations; and 2) Within-patient changes in quality of life and disability, as measured by the World Health Organization Disability Assessment Scale 2 (WHODAS 2.0).The hypotheses are: 1) intervention patients will have a 5 % relative reduction in unplanned hospitalizations as compared to control patients; and 2) reduced disability measured by WHODAS2.0; 3) destabilization or ‘tipping points’ leading to hospitalization will be more often triggered by psychosocial issues than by medical Issues. Conclusion This cluster RCT has the potential to transform the care for patients with high comorbidity by helping motivate patients to engage in self-management and to successfully navigate the barriers, challenges, and stresses leading to destabilization, hospitalization, and increased disability.ClinicalTrials.gov registration number: NCT04176510

Background Watchful waiting management for acute otitis media (AOM), where an antibiotic is used only if the child’s symptoms worsen or do not improve over the subsequent 2–3 days, is an effective approach to reduce antibiotic exposure for children with AOM. However, studies to compare the effectiveness of interventions to promote watchful waiting are lacking. The objective of this study is to compare the effectiveness and implementation outcomes of two pragmatic, patient-centered interventions designed to facilitate use of watchful waiting in clinical practice. Methods This will be a cluster-randomized trial utilizing a hybrid implementation-effectiveness design. Thirty-three primary care or urgent care clinics will be randomized to one of two interventions: a health systems-level intervention alone or a health systems-level intervention combined with use of a shared decision-making aid. The health systems-level intervention will include engagement of a clinician champion at each clinic, changes to electronic health record antibiotic orders to facilitate delayed antibiotic prescriptions as part of a watchful waiting strategy, quarterly feedback reports detailing clinicians’ use of watchful waiting individually and compared with peers, and virtual learning sessions for clinicians. The hybrid intervention will include the health systems-level intervention plus a shared decision-making aid designed to inform decision-making between parents and clinicians with best available evidence. The primary outcomes will be whether an antibiotic was ultimately taken by the child and parent satisfaction with their child’s care. We will explore the differences in implementation effectiveness by patient population served, clinic type, clinical setting, and organization. The fidelity, acceptability, and perceived appropriateness of the interventions among different clinician types, patient populations, and clinical settings will be compared. We will also conduct formative qualitative interviews and surveys with clinicians and administrators, focus groups and surveys of parents of patients with AOM, and engagement of two stakeholder advisory councils to further inform the interventions. Discussion This study will compare the effectiveness of two pragmatic interventions to promote use of watchful waiting for children with AOM to reduce antibiotic exposure and increase parent satisfaction, thus informing national antibiotic stewardship policy development. Clinical trial registration NCT06034080.

Abstract Introduction: Social determinants of health (SDOH) are an important contributor to health status and health outcomes. In this analysis, we compare SDOH measured both at the individual and population levels in patients with high comorbidity who receive primary care at Federally Qualified Health Centers in New York and Chicago and enrolled in the Tipping Points trial. Methods: We analyzed individual- and population-level measures of SDOH in 1,488 patients with high comorbidity (Charlson Comorbidity Index ≥ 4) enrolled in Tipping Points. At the individual level, we used a standardized patient-reported questionnaire. At the population level, we employed patient addresses to calculate the Social Deprivation Index (SDI) and Area Deprivation Index. Multivariable regressions were conducted in addition to qualitative feedback from stakeholders. Results: Individual-level SDOH are distinct from population-level measures. Significant component predictors of population SDI are being unhoused, unable to pay for utilities, and difficulty accessing medical transportation. Qualitative findings mirrored these results. High comorbidity patients report significant SDOH challenges at the individual level. Fitting a binomial generalized linear model, the comorbidity score is significantly predicted by the composite individual SDOH index (p < 0.0001) controlling for age and race/ethnicity. Conclusions: Individual- and population-level SDOH measures provide different risk assessments. The use of community-level SDI data is informative in the aggregate but should not be used to identify patients with individual unmet social needs. Health systems should implement a standardized individualized assessment of unmet SDOH needs and build strong, enduring partnerships with community-based organizations that can provide those services.

ImportanceWhile continuous glucose monitoring (CGM) has been found to improve diabetes care processes and outcomes, adoption remains low.ObjectiveTo examine the association between CGM prescriptions and individual characteristics among patients with type 1 or 2 diabetes (T1D and T2D, respectively).Design, Setting, and ParticipantsRetrospective cross-sectional study using electronic health record data for patients with T1D or T1D from 275 clinic sites nationwide between January 2014 and February 2021. All participating clinics were federally qualified health centers (FQHCs), the largest US system of primary care for vulnerable populations. Data were analyzed from September 2022 to August 2024.Main Outcomes and MeasuresSociodemographic factors, clinical characteristics, and CGM prescription orders.ResultsA total of 1168 patients with T1D (mean [SD] age, 41.8 [16.0] years; 600 [51.4%] male; 372 [31.9%] Black; 262 [22.4%] Hispanic, and 750 [64.2%] White patients) and 35 216 patients with T2D (mean [SD] age, 58.4 [13.1] years; 19 772 [56.1%] female; 12 030 [34.2%] Black; 12 979 [36.9%] Hispanic, and 20 413 [58.0] White patients) were included. Overall, CGM prescriptions were infrequent (129 [11.0%] for patients with T1D and 362 [1.0%] for those with T2D) but increased throughout the study period. Among patients with T1D, those who reported Hispanic ethnicity (odds ratio [OR], 0.30; 95% CI, 0.16-0.57), Black race (OR, 0.61; 95% CI, 0.38-0.99), or were uninsured (OR, 0.42; 95% CI, 0.23-0.74) had lower multivariable odds of receiving a CGM prescription than White or insured adults, respectively. Similar findings were observed among patients with T2D reporting Hispanic ethnicity (OR, 0.43; 95% CI, 0.32-0.57), Black race (OR, 0.76; 95% CI, 0.59-0.98), or being uninsured (OR, 0.42; 95% CI, 0.31-0.58), relative to their counterparts. Among patients with T2D, hemoglobin A1c values higher than 9.0% (OR, 3.17; 95% CI, 2.37-4.21) and a greater burden of diabetes complications were associated with higher odds of CGM prescription.Conclusions and RelevanceIn this cross-sectional study of electronic health record data, rates of CGM prescription orders were low among FQHC patients with T1D and T2D. Disparities in CGM orders were observed among patients reporting Hispanic ethnicity, Black race, and those who lacked health insurance. Future research is needed to understand the causes of infrequent CGM orders in FQHCs and drivers of observed disparities in this vulnerable patient population.

Objectives Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a “bundle” of evidence-based interventions significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.

Early onset Type 2 Diabetes (T2D) is characterized by earlier complications, but little is known about DM care in young adults with T2D in community health centers (CHCs). Using electronic health record data from a national CHC network, we examined sociodemographic characteristics, care patterns (i.e. medications, technology use), glycemic control and complications among young adults with T2D. We used logistic regression to identify factors associated with newer cardiovascular-DM medication use and complications. The cohort included 9,604 patients, 18-39 years, seen 1/3/2008-8/2/2023: 53% Hispanic, 26% Black (Table 1). Use of newer medications and insulin were as follows: GLP-1: 17%, SGLT-2: 12%, Insulin: 38%. Rates of microvascular or macrovascular complications were high both in those 18-29 (11% and 9%) and 30-39 years old (16% and 11%). Newer agent prescriptions (GLP-1 or SGLT-2) were less common among Hispanic and Black patients than Non-Hispanic and White patients [OR 0.84, (CI 0.73-0.96, p =0.01) and OR 0.66, (CI 0.56, 0.77, p < 0.001), respectively]. Hispanic patients also had higher odds of complications (microvascular or macrovascular) than Non-Hispanic patients [OR 1.23 (CI 1.08, 1.42), p=0.003]. Complications are common among young adults with T2D, yet prescription of novel agents is low. These findings highlight the translation gap in care for young adults with T2D and the need to understand drivers of care inequities. Disclosure S.E. DeLacey: None. A.L. Owen: None. E.L. Lam: None. K. Davis: None. A. Eggleston: None. E. Walter: None. M.J. O'Brien: None. A. Wallia: Research Support; UnitedHealth Group, Novo Nordisk. Funding Chicago Center for Diabetes Translation Research (NIDDK P30 DK092949 and 5P30DK020541-47)

INTRODUCTION:Does telehealth decrease health disparities by improving connections to care or simply result in new barriers for vulnerable populations who often lack access to technology? This study aims to better understand the role of telehealth and social determinants of health in improving care connections and outcomes for Community Health Center patients with diabetes.METHODS:This retrospective analysis of Electronic Health Record (EHR) data examined the relationship between telehealth utilization and glycemic control and consistency of connection to the health care team ("connectivity"). EHR data were collected from 20 Community Health Centers from July 1, 2019 through December 31, 2021. Descriptive statistics were calculated, and multivariable linear regression was used to assess the associations between telehealth use and engagement in care and glycemic control.RESULTS:The adjusted analysis found positive, statistically significant associations between telehealth use and each of the 2 primary outcomes. Telehealth use was associated with 0.89 additional months of hemoglobin A1c (HbA1c) control (95% confidence interval [CI], 0.73 to 1.04) and 4.49 additional months of connection to care (95% CI, 4.27 to 4.70).DISCUSSION:The demonstrated increased engagement in primary care for telehealth users is significant and encouraging as Community Health Center populations are at greater risk of lapses in care and loss to follow up.CONCLUSIONS:Telehealth can be a highly effective, patient-centered form of care for people with diabetes. Telehealth can play a critical role in keeping vulnerable patients with diabetes connected to their care team and involved in care and may be an important tool for reducing health disparities.

Introduction Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.Methods and analysis We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.Ethics and dissemination This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.Trial registration number ClinicalTrials.gov Registry (NCT04976881).

Federally qualified health centers (FQHCs) serve vulnerable DM patients in primary care in underserved settings. The state of DM (glycemic control, complications) may differ and utilization of technologies (e.g. continuous glucose monitoring [CGM]) may be essential. But the current state of DM and CGM is poorly characterized. Using EHR data from a national FQHC network (2015-2021) we examined baseline demographic characteristics, CGM prescriptions, and their association. We included 47,579 with DM: n=1630 with T1D [3%], n= 45,949 T2D [97%], 38% Hispanic, 34% Black (Table 1). Notably, T1D pts [mean age 43 SD 16], had poor glycemic control (HbA1c 9.4 SD 2.4) with elevated DM complications severity index scores [mean DSCI 2.3 SD 4.7]. Overall CGM prescriptions were extremely low; 9% in T1D and only 1% in T2D. Among T1D, those who were Hispanic [OR 0.39, (CI 0.23, 0.66), p < 0.001] or Black [OR 0.52, (CI 0.33, 0.81), p = 0.003] were less likely to have CGM prescribed than White adults, after adjustment. Among T2D, those who were Hispanic [OR 0.42, CI 0.33, 0.55, p < 0.001] or Black [OR 0.68, CI 0.54, 0.85, p = 0.001] were similarly less likely to have CGM. Non-private insurance was also a significant factor. DM severity (poor control, complications) is notable in FQHCs, yet CGM is exceptionally low. These findings underscore the major translation gap in standard of care for FQHCs and the critical need to understand inequities. Disclosure A. Wallia: Research Support; UnitedHealth Group, Novo Nordisk, Eli Lilly and Company. D. Bright: None. A. Eggleston: None. M. J. O'brien: None. S. Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. A. L. Owen: None. E. L. Lam: None. K. Davis: None. S. Bailey: Advisory Panel; Gilead Sciences, Inc., Consultant; Lundbeck, Pfizer Inc., Research Support; Eli Lilly and Company, Merck Sharp & Dohme Corp., Gilead Sciences, Inc., Lundbeck, Pfizer Inc. S. E. Delacey: None. A. Pack: Consultant; Gilead Sciences, Inc., Research Support; Merck & Co., Inc., Pfizer Inc., Gordon and Betty Moore Foundation, RRF Foundation for Aging, Lundbeck, Eli Lilly and Company, Gilead Sciences, Inc. J. Espinoza: Consultant; Sanofi, Research Support; NIH - National Institutes of Health, FDA, Speaker's Bureau; Glooko, Inc. Funding Centers for Diabetes Translation Research (5P30DK020541, 472P30DK092949-11A); National Pilot and Feasibility Grant for Diabetes Research Centers; Center for Diabetes Translation Research