Heather Kitzman

Equitable participation in clinical research is essential to generating broadly generalizable findings and advancing public health. Yet persistent sociodemographic disparities, driven by mistrust, limited access, and inadequate community engagement, continue to exclude underrepresented racial and ethnic groups from research. To address these barriers, the University of Texas Southwestern Medical Center developed a comprehensive, multi-component community engagement model designed to build trust and enhance research readiness among UREG. The model integrates eight synergistic programs aligned across the five-level Social Ecological Model, including HealthStreet screening events, a Health Needs Assessment, the Community Research Registry, the North Texas Community Health Coalition, Community Engagement Grand Rounds, the Spanish Language Resource, the Community Advisory Panel, and a Community Health Grant Program. These initiatives collectively provide culturally informed outreach and structured pathways for bidirectional input from community members. Since 2023, the model has achieved substantial impact, including 5069 community-based health screenings, over 100 consultations to investigators, and more than $44 million in funded grants. Findings demonstrate that sustained, multi-level engagement can strengthen trust, expand research access, and support more equitable translational science.

Background: Many Americans are in a coverage gap and unable to obtain affordable health insurance—particularly in non-Medicaid expanded states—which is associated with less preventative care, worse health outcomes, and a reliance on emergency care. Objective: To evaluate whether navigating uninsured patients to community-based primary care clinics that provide integrated care reduces preventable emergency visits and associated costs. Research Design: This retrospective study evaluated the volume and costs of emergency department (ED) and inpatient hospitalization for patients accessing community-based integrated primary care (BCC) located near hospital centers as compared with those receiving usual care (non-BCC). Subjects: The BCC group included 16,069 patients, and a propensity score-matched control group included 16,069 non-BCC patients. Patients less than 18 years old, with documented mental health issues, or whose electronic health record data were incomplete were excluded from the study. Measures: ED and inpatient hospitalization (IP) visits and direct costs. Results: Overall, the average per-person-year direct IP costs of BCC patients was 48% lower ( P <.001) and direct ED costs 43% lower ( P <.0001) than non-BCC patients. BCC patients had ∼44% fewer IP visits, and 29% fewer ED visits compared with non-BCC at 1–2 years of follow-up. BCC patients with diabetes related complications had 28% less IP costs and 27% less ED costs compared with non-BCC patients over 4 years ( P =.03, P =.01, respectively). Conclusions: This study supports the strategic navigation of uninsured patients from emergency departments and community settings to community-based primary care clinics offering integrated services, highlighting a promising population health approach.

BACKGROUND: Heart failure with reduced ejection fraction guideline-directed medical therapy remains underused, particularly in socioeconomically disadvantaged populations. It has been proposed that the use of combination pills (polypills) may facilitate prescribing of guideline-directed medical therapy and increase adherence. Understanding patient perspectives on implementation barriers and facilitators to the use of polypills is needed for developing effective strategies. METHODS: A convergent, parallel, mixed-methods study was conducted with participants who participated in a phase II randomized controlled trial of a heart failure with reduced ejection fraction polypill (POLY HF) in Dallas, TX. Six focus groups were conducted with participants from both polypill and usual care arms, followed by brief surveys. Qualitative data were analyzed using directed content analysis organized by a socioecological framework to identify barriers and facilitators across individual, interpersonal, and systems levels. Descriptive statistics characterized medication burden and polypill preferences. RESULTS: Study participants (n=41) included trial participants (n=36, mean 53 years, 53% Black race, 39% Hispanic) and caregivers (n=5). Quantitative data revealed substantial medication burden, with 58% taking ≥6 medications and 50.0% reporting missed doses, primarily due to forgetting (44%). 88.6% expressed interest in a polypill approach, and 83% believed it would improve adherence. Qualitative analysis identified multilevel implementation barriers and facilitators. Individual-level barriers included pill size concerns and uncertainty about polypill contents, while facilitators encompassed reduced pill burden, psychological benefits of taking fewer medications, and perceived health improvements. Interpersonal facilitators included caregiver enthusiasm for simplified medication management and strong provider trust. Systems-level barriers centered on cost concerns, while institutional trust facilitated acceptance. Mixed-methods integration revealed convergent findings. Quantitative medication burden aligned with qualitative themes of regimen complexity, while high quantitative interest in polypills was contextualized by practical implementation considerations regarding formulation and delivery. CONCLUSIONS: In socioeconomically disadvantaged patients with heart failure with reduced ejection fraction, a polypill strategy demonstrated strong patient acceptability, supporting further implementation research. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04633005.

Background Years into the immune checkpoint inhibitor (ICI) era, immune-related adverse events (irAE) remain largely unpredictable. Prior studies have examined irAE associations with weight and metabolic diseases, yielding mixed findings. We therefore analyzed these and other variables potentially associated with heightened inflammation and irAE development. Methods For ICI-treated individuals enrolled in a prospective institutional clinical and biospecimen registry, we collected demographic, clinical, laboratory, and residence data, pre-ICI serum cytokine levels, and irAE details. We calculated metabolic syndrome (MetS) and area deprivation index (ADI, a measure of neighborhood socioeconomic status), both of which have been associated with heightened inflammation. Patients were categorized as having MetS if they had ≥ 3 of 5 criteria at ICI initiation: hypertension, obesity, elevated HbA1c, low HDL, elevated triglycerides. Baseline serum cytokine/chemokine levels were determined using a multiplex platform. We analyzed associations across variables using logistic regression, Mann–Whitney U, and Cochran Armitage tests, accounting for multiple comparisons. Results Overall, 178 ICI-treated patients were included in the analysis, of whom 99 (56%) were classified as having MetS. In multivariable analysis, patients with MetS had greater odds of both grade ≥ 2 irAE (OR 2.82; 95% CI, 1.35–6.14; P = 0.007) and grade ≥ 3 irAE (OR 3.53; 95% CI 1.27–11.68; P = 0.02). However, MetS was not associated with pre-treatment cytokine levels. In contrast, ADI was associated with multiple inflammatory cytokines but not with MetS or irAE. Conclusions MetS is associated with increased likelihood of moderate and severe irAE. The mechanism and mitigation of this risk merit further investigation.

Key Points: Social cognitive theory guided identification of facilitators & barriers to increase fruit & vegetable intake in African American persons with CKD. This study found that ongoing social determinants such as access to healthy foods and costs continue after study support is removed. Community health workers were a source of social support and encouragement that improved motivation for healthy eating and study participation. Background: CKD disproportionately affects African American persons with incidence rates 2–4 times that of White persons. Structural inequities such as limited access to healthy foods and lower socioeconomic status might be contributing factors. The Fruits and Vegetables for Kidney Health Study was a randomized controlled trial in African American persons with CKD that demonstrated reductions in urine albumin-to-creatinine ratio when participants were given free fruits and vegetables (FV) over 6 months with or without a 6-week cooking class. This qualitative study aimed to understand participant experiences in each group, using social cognitive theory to identify program components that contributed to FV intake and can inform future interventions. Methods: Focus groups were held virtually and in-person. Focus group questions were informed by Social Cognitive Theory to evaluate study participation, changes to self-efficacy, barriers, and benefits to individual and community-level FV intake. An applied thematic analysis approach was used for data analysis with trained staff using MAXQDA. Results: Six focus groups were conducted ( N =40; 100% African American persons, mean age 63 years, 83% female, 58% with annual income <$25,000). Primary themes included ( 1 ) study participation empowered participants to change food-related behaviors; ( 2 ) care and accountability from staff positively influenced participant engagement; ( 3 ) barriers affect the sustainability of recently acquired skills and health habits; and ( 4 ) enhance program reach through intergenerational social connections and social media. Conclusions: Access to both FV alone and with cooking classes had positive effects on reported FV intake, although cooking class participants reported greater benefits. Sustainability of changes, particularly after access to free produce ends, remains challenging. Participants indicated that integrating community health workers and staff skilled in diverse populations promoted participant trust and long-term engagement. Finally, expanding intervention targets to include family and social media could further enhance reach and support for kidney health promoting foods.

Introduction: A lack of coordinated federal guidance led to substantial heterogeneity in local COVID-19 policies across US states and counties. Local government policies may have contributed to increases in anxiety and mental health disparities during the COVID-19 pandemic. Methods: We analysed associations between composite policy scores for containment and closure, public health or economic support from the US COVID-19 County Policy Database and self-reported anxiety scores (Generalised Anxiety Disorder-7) from COVID-19 Citizen Science participants between 22 April 2020 and 31 December 2021. Results: In 188 976 surveys from 36 711 participants in 100 counties across 28 states, associations between anxiety and containment and closure policy differed by employment (p<0.0001), with elevated anxiety under maximal policy for people working in hospitality and food services (+1.05 vs no policy; 95% CI: 0.45, 1.64) or arts and entertainment (+0.56; 95% CI 0.15, 0.97) and lower anxiety for people working in healthcare (−0.43; 95% CI −0.66 to –0.20) after adjusting for calendar time, county-specific effects and COVID-19 case rates and death rates. For public health policy, associations differed by race and ethnicity (p=0.0016), with elevated anxiety under maximal policy among participants identifying as non-Hispanic Black (+1.71; 95% CI 0.26, 3.16) or non-Hispanic Asian (+0.74; 95% CI 0.05, 1.43) and lower anxiety among Hispanic participants (−0.63, 95% CI −1.26 to –0.006). Associations with public health policy also differed by gender (p<0.0001), with higher anxiety scores under maximal policy for male participants (+0.42, 95% CI 0.09, 0.75) and lower anxiety for female participants (−0.40, 95% CI −0.67 to –0.13). There were no significant differential associations between economic support policy and sociodemographic subgroups. Conclusions: Associations between local COVID-19 policies and anxiety varied substantially by sociodemographic characteristics. More comprehensive containment policies were associated with elevated anxiety among people working in strongly affected sectors, and more comprehensive public health policies were associated with elevated anxiety among people vulnerable to racial discrimination.

Chronic kidney disease (CKD) impacts 14% of adults in the United States, and African American (AA) individuals are disproportionately affected, with more than 3 times higher risk of kidney failure as compared to White individuals. This study evaluated the effects of base-producing fruit and vegetables (FVs) on cardiorenal outcomes in AA persons with CKD and hypertension (HTN) in a low socioeconomic area. The “Cardiorenal Protective Diet” prospective randomized trial evaluated the effects of a 6-week, community-based FV intervention compared to a waitlist control (WL) in 91 AA adults (age = 58.3 ± 10.1 years, 66% female, 48% income ≤ USD 25K). Biometric and metabolomic variables were collected at baseline and 6 weeks post-intervention. The change in health outcomes for both groups was statistically insignificant (p > 0.05), though small reductions in albumin to creatinine ratio, body mass index, total cholesterol, and systolic blood pressure were observed in the FV group. Metabolomic profiling identified key markers (p < 0.05), including C3, C5, 1-Met-His, kynurenine, PC ae 38:5, and choline, indicating kidney function decline in the WL group. Overall, delivering a directed cardiorenal protective diet intervention improved cardiorenal outcomes in AA adults with CKD and HTN. Additionally, metabolomic profiling may serve as a prognostic technique for the early identification of biomarkers as indicators for worsening CKD and increased CVD risk.

The global impact of diet-sensitive disease demands innovative nutrition education for health professionals and widespread, reimbursable clinical models to apply nutrition to practice. Interprofessional collaboration across disciplines and the optimization of emerging telemedicine consultation strategies, including electronic consultation (eConsult), merge to deliver vital innovation in the delivery of nutrition-based clinical care. Aligning with an existing eConsult infrastructure in the institutional electronic health record (EHR), a physician–dietitian team developed a novel Culinary Medicine eConsult. During a pilot phase, the service was introduced to primary care clinicians, and a response algorithm for eConsults was created. During the 12-month pilot phase, the Culinary Medicine team completed 25 eConsults from 11 unique primary care clinicians with a 76% (19/25) insurance reimbursement rate. Topics varied from dietary strategies for preventing and managing common metabolic diseases to specific dietary influences on microbiome health and disease flares. Requesting clinicians reported time saved in their clinic encounters and high patient satisfaction with expert nutrition guidance. EConsults in Culinary Medicine promote the integration of interprofessional nutrition care into existing clinical structures and empower enhanced access to the vital domain of dietary health. EConsults deliver timely answers to clinical questions and create opportunities for further innovation in care delivery as communities, health systems, and payors seek solutions to the growing burden of diet-sensitive diseases.

Background: Web-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues. Objective: This study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with overweight or obesity. Methods: Parent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children’s weight loss goals (session contents included energy balance, fast food, fruits and vegetables, physical activity [PA], sedentary behavior, and sweetened beverages). MVPA was measured using accelerometers at baseline and after the intervention. Results: Using a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA (B=−12.561, 95% CI −18.759 to −6.367), but MVPA increased with greater log-in duration for the PA (B=0.008, 95% CI 0.004-0.012) and sedentary behavior (B= 0.008, 95% CI 0.004-0.012) sessions. These results suggest that parents who logged in to the PA session had lower MVPA, but MVPA increased with greater log-in duration for the PA and sedentary behavior sessions. These associations remained even after accounting for engagement with other content sessions. However, these engagement effects did not translate to the adolescents. Conclusions: The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families. Trial Registration: ClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067