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Personalized dietary feedback mediates the association of dietary self-monitoring adherence and weight loss: a post-hoc analysis of the Personal Diet Study
Berube, Lauren T; Wang, Chan; Curran, Margaret; Pompeii, Mary Lou; Hu, Lu; Barua, Souptik; Li, Huilin; St-Jules, David E; Schoenthaler, Antoinette; Segal, Eran; Bergman, Michael; Popp, Collin J
BACKGROUND:Dietary self-monitoring is central to effective personalized nutrition, providing critical data to inform tailored feedback and support behavior change. OBJECTIVE:To examine the impact of dietary self-monitoring adherence and the indirect effect of personalized scores to predict postprandial glycemic response (PPGR) on weight loss. METHODS:Post-hoc analysis of the Personal Diet Study that investigated the impact of a machine algorithm-based diet that integrates clinical and microbiome features (Personalized) compared to a standard, low-fat diet (Standardized) on weight loss. All participants received behavioral counseling and were encouraged to self-monitor dietary intake via a smartphone app. Personalized received algorithm-based scores (1 to 5) on predicted PPGR to foods logged (PPGR score; 1-2 indicating optimal; 3-5 suboptimal). Dietary self-monitoring adherence was the percentage of days logging ≥50% of target calories, classified as high or low. PPGR score quality was calculated by the proportion of optimal predicted PPGR scores per day; defined as "high-PPGR quality" days when this exceeded the group average. Mediation analysis assessed whether PPGR quality mediated the relationship between dietary self-monitoring adherence and weight loss. RESULTS:Participants with high self-monitoring adherence lost an average of 4.2% of their baseline weight, compared to 1.9% among those with low adherence (p=0.016). High self-monitoring adherence was associated with a greater likelihood of achieving ≥5% weight loss (aOR=3.67, 95% CI: 1.63-8.50). Within Personalized, high PPGR quality mediated 53.4% of the total effect of self-monitoring adherence on weight loss (p<0.001). CONCLUSION/CONCLUSIONS:Consistent self-monitoring coupled with personalized feedback may significantly enhance weight loss in a precision nutrition approach. CLINICAL TRIAL REGISTRATION/BACKGROUND:NCT03336411.
PMID: 41539436
ISSN: 1541-6100
CID: 5986592
Healthcare Professionals' Perspectives on Addressing Patients' Medication Adherence in Primary Care Settings
Martinez, Tiffany R; Schoenthaler, Antoinette M; Mann, Devin M; Belli, Hayley; Bearnot, Harris R; Lustbader, Ian; Blecker, Saul
BACKGROUND:Medication nonadherence is a common issue among patients with hypertension. Healthcare professionals often overlook medication nonadherence due to limited tools, time constraints, and competing demands. Integrating pharmacy medication fill data into electronic health records (EHRs) presents an opportunity to enhance medication adherence measurement and monitoring in real-time. This study identified facilitators and barriers to addressing adherence to antihypertensive medications by Medical Assistants (MAs), Registered Nurses (RNs), and Primary Care Providers (PCPs) in primary care settings. METHODS:We conducted a qualitative study with, 15 healthcare professionals (5 MAs, 5 RNs, and 5 PCPs) caring for patients with hypertension. Semi-structured interviews, guided by the Consolidated Framework for Implementation Research (CFIR), explored barriers and facilitators related to screening and addressing medication non-adherence during primary care clinical encounters. Thematic analysis and deductive coding were used to analyze the data. RESULTS:Four major themes emerged: motivation, work infrastructure, capability, and opportunity. MAs and PCPs were motivated to discuss medication adherence and build relationships. Capability varied; RNs were confident in their counseling skills based on their training and patient trust, and PCPs described adherence counseling as part of their role, particularly through motivational interviewing. Work infrastructure presented structural hurdles due to RN workflow limitations and MA role constraints. Opportunity to address non-adherence were constrained by tight schedules and competing clinical demands during brief visits. CONCLUSIONS:RNs and PCPs felt capable in their ability to address medication adherence but cited time and competing demands as significant barriers; conversely, MAs reported motivation but were limited by their role. These findings suggest opportunities for effective management of medication adherence in practice settings through a more coordinated strategy across multiple healthcare professionals. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov; NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422.
PMID: 41308044
ISSN: 1365-2753
CID: 5968612
Behavioral Economics and Medication Adherence for Hypertension: A Randomized Clinical Trial
Dodson, John A; Adhikari, Samrachana; Schoenthaler, Antoinette M; Shimbo, Daichi; Berman, Adam N; Levy, Natalie; Hanley, Kathleen; Richardson, Safiya; Varghese, Ashwini; Meng, Yuchen; Pena, Stephanie; de Brito, Stefany; Gutierrez, Yasmin; Rojas, Michelle; Rosado, Victoria; Olkhinha, Ekaterina; Troxel, Andrea B
BACKGROUND:Nonadherence to antihypertensive medications is common. Mobile health (mHealth)-based behavioral economic interventions may improve adherence, but remain largely untested, especially in vulnerable populations. OBJECTIVE:The study sought to test whether an mHealth incentive lottery would lower systolic blood pressure (SBP) and improve adherence. METHODS:BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) was a randomized trial conducted in 3 safety-net clinics in New York City. Eligible participants were adults with hypertension prescribed at least 1 antihypertensive medication, with SBP >140 mm Hg, and poor self-reported adherence. In the intervention arm, an incentive lottery was administered via SMS messaging. All participants received passive adherence monitoring. The intervention lasted 6 months, with continued monitoring until 12 months. The primary clinical endpoint was change in SBP at 6 months. The primary process endpoint was adequate antihypertensive medication adherence (≥80% days adherent) from baseline to 6 months. RESULTS:Four-hundred participants (265 intervention:135 control) were enrolled with median age 57 years, 60.5% women, 61.5% Hispanic, and 20.3% non-Hispanic Black. Over 70% had Medicaid or no insurance. At 6 months, intervention arm participants were twice as likely to achieve adequate adherence (71% vs 34%; adjusted risk ratio: 2.04; 95% CI: 1.58-2.63), but there was no significant change in mean SBP (-6.7 mm Hg intervention vs -5.8 mm Hg control; P = 0.62). From 6 to 12 months, adherence was similar (31% intervention vs 26% control; adjusted risk ratio: 1.17; 95% CI: 0.83-1.65). CONCLUSIONS:In a diverse safety-net population, the BETTER-BP intervention doubled the rate of adequate antihypertensive medication adherence but did not reduce SBP at 6 months.
PMID: 41379039
ISSN: 1558-3597
CID: 5977742
Access to Care for the Endodontic Treatment of Pediatric Patients: A Qualitative Study
Mathews, Melissa; Boykins, Julian; Schoenthaler, Antoinette M; Gold, Heather T; Burns, Lorel E
BACKGROUND:Clinical approaches for pediatric patients requiring endodontic treatment have been associated with specialty type. AIM/OBJECTIVE:The purpose of this study was to elucidate the nuanced clinical decision-making process for endodontic treatment of pediatric patients' permanent teeth. DESIGN/METHODS:A qualitative design was used to explore the experiences and decision-making of general dentists, pediatric dentists, and endodontists. Clinicians practicing in the United States were recruited to interview using purposive sampling methods. A framework, thematic analytic approach was used to evaluate the data. RESULTS:In total, 26 dentists participated in the study: 7 general dentists, 11 pediatric dentists, 6 endodontists, and 2 dual-trained specialists. Overall, clinicians reported that caries on permanent first molars were the most common reason that pediatric patients required endodontic treatment. Access to care was influenced by practitioner clinical training and knowledge; patient behavior; and financial considerations. Treatment planning was influenced by parents, referrals, and clinical philosophy. CONCLUSIONS:The findings explain how clinician decision-making and system-level factors influence access to care for pediatric patients in need of endodontic treatment and propagate oral health disparities. Barriers to accessing care were most limiting for children and adolescents from low-income households and were likely to result in premature tooth loss.
PMID: 41225291
ISSN: 1365-263x
CID: 5966872
Goal Attainment Among Older Adults With Ischemic Heart Disease Using Mobile-Health Cardiac Rehabilitation in RESILIENT
Shwayder, Elianna M; Dodson, John A; Adhikari, Samrachana; Grant, Eleonore V; Schoenthaler, Antoinette M; Pena, Stephanie; Meng, Yuchen; Jennings, Lee A
BACKGROUND:Data on patient-centered outcomes of mobile health cardiac rehabilitation (mHealth-CR) for older adults with ischemic heart disease are limited. The RESILIENT (Rehabilitation at Home Using Mobile Health in Older Adults After Hospitalization for Ischemic Heart Disease) trial, the largest randomized study of mHealth-CR in this population, found no significant improvements in functional capacity, health status, angina, or disability compared with usual care. OBJECTIVES/OBJECTIVE:The purpose of this study was to evaluate whether mHealth-CR affects personalized goal attainment-a prespecified secondary endpoint of RESILIENT-using goal attainment scaling (GAS). METHODS:A total of 400 patients (≥65 years) with ischemic heart disease were randomized to mHealth-CR or usual care. Participants specified goals for CR at baseline using the five-category goal attainment scale: much-less-than-expected (-2), less-than-expected (-1), expected (0), better-than-expected (+1), and much-better-than-expected (+2). Goal attainment was assessed at 3 months. RESULTS:Of 400 patients (median age, 71.0 years [range 65.0-91.0]; 72.8% male; 65.2% prefrail/frail) randomized to mHealth-CR (n = 298) or usual care (n = 102), 353 (88.3%) completed GAS. Most goals addressed physical activity (54.0% mHealth-CR vs 59.0% usual care), health care behaviors (14.4% vs 11.9%), or symptom management (13.1% vs 9.0%). Rates of attaining or exceeding goals (GAS ≥0) were similar between groups (80.5% vs 77.6%; P = 0.492). However, in the intervention arm, there was a higher rate of exceeding expected level of goal attainment (GAS +1, +2) compared with usual care (52.6% vs 34.2%; P = 0.006). CONCLUSIONS:In a trial that did not demonstrate differences on traditional endpoints, those receiving mHealth-CR were more likely to exceed personalized CR goals. These findings suggest the intervention facilitated greater progress toward individualized goals and underscore the importance of patient-centered outcomes in CR.
PMID: 41231194
ISSN: 2772-963x
CID: 5967012
Patient Utilization of Remote Patient Monitoring in a Pilot Implementation at a Federally Qualified Health Center
Groom, Lisa L; Schoenthaler, Antoinette M; Budhrani, Rishika; Mann, Devin M; Brody, Abraham A
PMID: 40735809
ISSN: 1556-3669
CID: 5903442
Community engagement for effective recruitment of Black men at risk for hypertension: baseline data from the Community-to-Clinic Program (CLIP) randomized controlled trial
Arabadjian, Milla; Green, Tanisha; Foti, Kathryn; Dubal, Medha; Poudel, Bharat; Christenson, Ashley; Wang, Zhixin; Dietz, Katherine; Brown, Deven; Liriano, Kenia; Onaga, Ericker; Mantello, Ginny; Schoenthaler, Antoinette; Cooper, Lisa A; Spruill, Tanya M; Ogedegbe, Gbenga; Ravenell, Joseph
BACKGROUND:Black men are underrepresented in hypertension trials, even though this population has higher prevalence and more adverse sequelae from hypertension, compared to other groups. In this article we present recruitment and community engagement strategies for the Community-to-Clinic Linkage Implementation Program (CLIP), a cluster-randomized trial on hypertension prevention among Black men. METHODS:Using a 2-stage recruitment process: 1) we enrolled Black-owned barbershops from zip-codes with high hypertension prevalence; and 2) recruited Black male participants who fulfilled the eligibility criteria and were customers of the barbershops. Barbershop and participant recruitment was conducted by a partner community-based organization. RESULTS:The study met the recruitment goals for barbershop enrollment (N=22) and individual participants. Of eligible individuals (N=461), 430 enrolled in the study (93% consent rate, exceeding the original enrollment goal of N=420 participants). Throughout recruitment, the study team conducted 101 unique engagements (41 prior to recruitment, 60 during recruitment), totaling engagement with180 partners across all events, including individual and group meetings, attendance at community events, and educational presentations. In addition to a primary partner community organization, the study team collaborated with a Community Advisory Council, comprised of residents, and civic and community leaders, and with the local health department and varied other organizations. CONCLUSIONS:In CLIP, a high number of academic-community engagement encounters and close collaboration with community partners contributed to successful recruitment of Black men at risk for hypertension and with adverse social determinants. Our experience may serve as to inform investigators focused on recruiting underserved populations in hypertension research trials.
PMID: 40482027
ISSN: 1941-7225
CID: 5862972
Medication Adherence in Hypertension: A Cluster Randomized Clinical Trial
Blecker, Saul; Mann, Devin M; Martinez, Tiffany R; Belli, Hayley M; Zhao, Yunan; Ahmed, Aamina; Fitchett, Cassidy; Wong, Christina; Bearnot, Harris R; Voils, Corrine I; Schoenthaler, Antoinette M
IMPORTANCE/UNASSIGNED:Medication nonadherence is present in nearly half of patients with hypertension but is underrecognized in clinical care. Data linkages between electronic health records and pharmacies have created opportunities for scalable assessment of medication adherence at the point of care. OBJECTIVE/UNASSIGNED:To test the effectiveness of a multicomponent intervention that identified patients with uncontrolled hypertension and medication nonadherence using linked electronic health record-pharmacy data combined with team-based care to address adherence barriers. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:TEAMLET (Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence) was a pragmatic, 2-arm, cluster randomized clinical trial conducted between October 2022 and November 2024 in 10 primary care sites in New York. The study included adults with uncontrolled hypertension and low medication adherence, defined as proportion of days covered (PDC) less than 80%. Data analysis was performed from November 2024 to January 2025. INTERVENTION/UNASSIGNED:The intervention consisted of the following: (1) automated identification of patients with medication nonadherence at the time of the visit; (2) prompting of medical assistants to screen for barriers to adherence; (3) clinical decision support alerting the primary care physicians and nurse practitioners to barriers to adherence; and (4) adherence discussion between the primary care physician or nurse practitioner and the patient. The comparator was usual care. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in PDC from baseline to 12 months. RESULTS/UNASSIGNED:Among 1726 patients (mean [SD] age, 67.2 [13.9] years; 887 [51.4%] female), the mean (SD) baseline PDC was 33.2% (30.5%) overall (32.4% [30.4%] in the intervention group and 34.0% [30.6%] in the control group). The mean (SD) PDC at 12 months was 51.1% (39.5%) for the intervention group and 53.1% (39.6%) for the control group. No difference was found in the change in PDC from baseline to 12 months between the intervention and control groups (mean [SD] absolute change in PDC, 18.5 [41.1] vs 18.2 [40.9] percentage points, respectively; adjusted difference, -0.15 percentage point; 95% CI, -4.06 to 3.76 percentage points). Change in systolic blood pressure and patients who became adherent (PDC ≥80%) at 12 months were also similar between groups. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this pragmatic trial, an intervention that combined team-based primary care with automated identification of patients with antihypertensive medication nonadherence did not lead to improvements in adherence or blood pressure. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT05349422.
PMCID:12242813
PMID: 40632527
ISSN: 2380-6591
CID: 5890882
Cardiovascular Health Markers with Remote Team-Based Hypertension Management in a Safety-Net Population
Chervonski, Ethan; Pelegri, Elan; Calle, Franzenith De La; Mandal, Soumik; Graves, Claire A; Colella, Doreen; Elmaleh-Sachs, Arielle; Nay, Jacalyn; Dapkins, Isaac; Schoenthaler, Antoinette
INTRODUCTION/BACKGROUND:The impact of remote patient monitoring (RPM) for hypertension (HTN) on cardiovascular health (CVH) remains ill-defined. This study characterized the association between a RPM, team-based HTN intervention and CVH markers. METHODS:This retrospective, single-arm cohort study included patients with uncontrolled HTN enrolled February 2022-July 2024 in the ALTA trial (clinicaltrials.gov NCT03713515) at five safety-net practices. The ALTA intervention involves RPM supported by a virtual clinic including a nurse practitioner (NP), registered nurse, and community health worker. Demographics, ALTA utilization, and CVH markers (blood pressure [BP], lipids, glycemic indicators, body mass index [BMI], and smoking) at baseline and 12 months were collected. Five markers were scored (0=poor, 1=intermediate, 2=ideal) and summed into a CVH score. The primary endpoint was the 12-month CVH score change in patients with baseline score ≤7. Secondary endpoints included individual non-BP marker changes in patients with baseline derangements. RESULTS:Among 568 patients (mean age: 56 years), most were female, non-Hispanic Black, and English-speaking. NP visits were more common among females (p=0.04); no other demographics predicted ALTA utilization. The CVH score improved from 4.5 to 5.2 (n=196, p<0.001), independent of ALTA utilization. Total cholesterol (n=86, p<0.001), LDL (n=128, p<0.001), and triglycerides (n=51, p=0.004) improved. Hemoglobin A1c (n=195) dropped among patients with ≥1 NP visit (p=0.02). Fasting glucose (n=135) and BMI (n=289) decreased in the highest tertile of NP visits (p=0.03) and RPM (p=0.02), respectively. 4 of 27 patients quit smoking. CONCLUSIONS:RPM with team-based support was associated with CVH improvements. Benefits may depend on intervention utilization.
PMID: 40763829
ISSN: 1873-2607
CID: 5905042
Lessons Learned from the Usability Assessment of an EHR-Based Tool to Support Adherence to Antihypertensive Medications
Elkefi, Safa; Martinez, Tiffany R; Nadel, Talia; Schoenthaler, Antoinette M; Mann, Devin M; Blecker, Saul
Uncontrolled hypertension is common and frequently related to inadequate adherence to prescribed medications, resulting in suboptimal blood pressure control and increased healthcare utilization. Although healthcare providers have the opportunity to improve medication adherence, they may lack the tools to address adherence at the point of care. This study aims to assess the usability of a digital tool designed to improve medication adherence and blood pressure control among patients with hypertension who are not adherent to therapy. By evaluating usability, the study seeks to refine the tool's design, underscore the role of technology in managing hypertension, and provide insights to inform clinical decisions.We performed qualitative usability testing of an electronic health record (EHR)-integrated intervention with medical assistants (MAs) and primary care providers (PCPs) from a large integrated health system. Usability was assessed with these end-users using the "think aloud" and "near live" approaches. This evaluation was guided by two frameworks: the End-User Computing Satisfaction Index (EUCSI) and the Technology Acceptance Model (TAM). Interviews were analyzed using a thematic analysis approach.Thematic saturation was reached after usability testing was performed with 10 participants, comprising 5 PCPs and 5 MAs. The study identified several strengths within the content, format, ease of use, timeliness, accuracy, and usefulness of the tool, including the user-friendly content presentation, the usefulness of adherence information, and timely alerts that fit into the workflow. Challenges centered around alert visibility and specificity of information.Leveraging the two conceptual frameworks (TAM and EUCSI) to test the usability of the medication adherence tool was helpful. The tool's several strengths and opportunities for improvement were found. The resulting suggestions will be used to support the enhancement of the design for optimal implementation in a clinical trial.
PMCID:12352985
PMID: 40812382
ISSN: 1869-0327
CID: 5907672