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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
Titration and discontinuation of semaglutide for weight management in commercially insured US adults
Xu, Yunwen; Carrero, Juan J; Chang, Alexander R; Inker, Lesley A; Zhang, Donglan; Mukhopadhyay, Amrita; Blecker, Saul B; Horwitz, Leora I; Grams, Morgan E; Shin, Jung-Im
OBJECTIVE:The objective of this study is to examine real-world dose titration patterns of semaglutide for weight management (Wegovy, Novo Nordisk A/S) in US adults and identify characteristics associated with early discontinuation. METHODS:We identified 15,811 commercially insured adults who started semaglutide for weight management (administrated through single-dose prefilled pens) between June 2021 and December 2023. We depicted dose-titration patterns over 5 months and identified factors associated with discontinuation using multivariable Cox regression. Sensitivity analyses examined patterns after supply shortage resolution (after October 2023). RESULTS:Most semaglutide users deviated from the recommended monthly dose-escalation schedule within the first 5 months. By the fifth month, nearly one-half (46%) had discontinued the treatment, with similar rates (48%) among those initiating after supply stabilization. Discontinuation was strongly associated with copayment amount, with rates increased from 41% in the lowest quintile ($1-$54 per month) to 51% in the highest quintile ($161-$1460 per month). Higher discontinuation rates were also associated with lower household income and education level. CONCLUSIONS:The deviations from the recommended dose-escalation schedule and high discontinuation rate among real-world semaglutide users indicate important challenges in the delivery of evidence-based care. Policy interventions that reduce financial barriers to the persistence of semaglutide are needed.
PMID: 40464214
ISSN: 1930-739x
CID: 5862372
Clinical Decision Support Leveraging Health Information Exchange improves Concordance with Patient's Resuscitation Orders and End-Of-Life Wishes
Chakravartty, Eesha; Silberlust, Jared; Blecker, Saul; Zhao, Yunan; Alendy, Fariza; Menzer, Heather; Ahmed, Aamina; Jones, Simon; Ferrauiola, Meg; Austrian, Jonathan Saul
Objectives Improve concordance between patient end-of-life preferences and code status orders by incorporating data from a state registry with Clinical Decision Support (CDS) within the electronic health record (EHR) to preserve patient autonomy and ensure that patients receive care that aligns with their wishes. Methods Leveraging a Health Information exchange (HIE) interface between the New York State Medical Orders for Life-Sustaining Treatment (eMOLST) registry and the EHR of our academic health system, we developed a bundled CDS intervention that displays eMOLST information at the time of code status ordering and provides an in-line alert when providers enter a resuscitation order discordant with wishes documented in the eMOLST registry. To evaluate this intervention, we performed a segmented regression analysis of an interrupted times series to compare percentage of discordant orders before and after implementation among all hospitalizations for which an eMOLST was available. Results We identified a total of 3648 visits that had an eMOLST filed prior to inpatient admission and a code status order placed during admission. There was a statistically significant decrease of discordant resuscitation orders of -5.95% after the intervention went live, with a relative risk reduction of 25%, [95% CI: -9.95%, -1.94%, p=0.009] in the pre- and post-intervention period. Logistic regression model after adjusting for co-variates showed an average marginal effect of -5.12% after the intervention [CI =-9.75%, -0.50%, p=0.03]. Conclusions Our intervention resulted in a decrease in discordant resuscitation orders. This study demonstrates that accessibility to eMOLST data within the provider workflow supported by CDS can reduce discrepancies between patient end-of-life wishes and hospital code status orders.
PMID: 40267976
ISSN: 1869-0327
CID: 5830322
Association of Patient Cost-Sharing With Adherence to GLP-1a and Adverse Health Outcomes
Zhang, Donglan; Gencerliler, Nihan; Mukhopadhyay, Amrita; Blecker, Saul; Grams, Morgan E; Wright, Davene R; Wang, Vivian Hsing-Chun; Rajan, Anand; Butt, Eisha; Shin, Jung-Im; Xu, Yunwen; Chhabra, Karan R; Divers, Jasmin
OBJECTIVE:To examine the associations between patient out-of-pocket (OOP) costs and nonadherence to glucagon-like peptide 1 receptor agonists (GLP-1a), and the consequent impact on adverse outcomes, including hospitalizations and emergency department (ED) visits. RESEARCH DESIGN AND METHODS/METHODS:This retrospective cohort study used MarketScan Commercial data (2016-2021). The cohort included nonpregnant adults aged 18-64 years with type 2 diabetes who initiated GLP-1a therapy. Participants were continuously enrolled in the same private insurance plan for 6 months before the prescription date and 1 year thereafter. Exposures included average first 30-day OOP costs for GLP-1a, categorized into quartiles (lowest [Q1] to highest [Q4]). Primary outcomes were the annual proportion of days covered (PDC) for GLP-1a and nonadherence, defined as PDC <0.8. Secondary outcomes included diabetes-related and all-cause hospitalizations and ED visits 1 year post-GLP-1a initiation. RESULTS:Among 61,907 adults who initiated GLP-1a, higher 30-day OOP costs were associated with decreased adherence. Patients in the highest OOP cost quartile (Q4: $80-$3,375) had significantly higher odds of nonadherence (odds ratio [OR]1.25; 95% CI 1.19-1.31) compared with those in Q1 ($0-$21). Nonadherence was linked to increased incidence rates of diabetes-related hospitalizations or ED visits (incidence rate ratio [IRR] 1.86; 95% CI 1.43-2.42), cumulative length of hospitalization (IRR 1.56; 95% CI 1.41-1.72), all-cause ED visits (IRR 1.38; 95% CI 1.32-1.45), and increased ED-related costs ($69.81, 95% CI $53.54-$86.08). CONCLUSIONS:Higher OOP costs for GLP-1a were associated with reduced adherence and increased rates of adverse outcomes among type 2 diabetes patients.
PMID: 40202527
ISSN: 1935-5548
CID: 5823882
Pediatric Long COVID Subphenotypes: An EHR-based study from the RECOVER program
Lorman, Vitaly; Bailey, L Charles; Song, Xing; Rao, Suchitra; Hornig, Mady; Utidjian, Levon; Razzaghi, Hanieh; Mejias, Asuncion; Leikauf, John Erik; Brill, Seuli Bose; Allen, Andrea; Bunnell, H Timothy; Reedy, Cara; Mosa, Abu Saleh Mohammad; Horne, Benjamin D; Geary, Carol Reynolds; Chuang, Cynthia H; Williams, David A; Christakis, Dimitri A; Chrischilles, Elizabeth A; Mendonca, Eneida A; Cowell, Lindsay G; McCorkell, Lisa; Liu, Mei; Cummins, Mollie R; Jhaveri, Ravi; Blecker, Saul; Forrest, Christopher B; ,
Pediatric Long COVID has been associated with a wide variety of symptoms, conditions, and organ systems, but distinct clinical presentations, or subphenotypes, are still being elucidated. In this exploratory analysis, we identified a cohort of pediatric (age <21) patients with evidence of Long COVID and no pre-existing complex chronic conditions using electronic health record data from 38 institutions and used an unsupervised machine learning-based approach to identify subphenotypes. Our method, an extension of the Phe2Vec algorithm, uses tens of thousands of clinical concepts from multiple domains to represent patients' clinical histories to then identify groups of patients with similar presentations. The results indicate that cardiorespiratory presentations are most common (present in 54% of patients) followed by subphenotypes marked (in decreasing order of frequency) by musculoskeletal pain, neuropsychiatric conditions, gastrointestinal symptoms, headache, and fatigue.
PMCID:11984710
PMID: 40208885
ISSN: 2767-3170
CID: 5824132
Kidney Function Following COVID-19 in Children and Adolescents
Li, Lu; Zhou, Ting; Lu, Yiwen; Chen, Jiajie; Lei, Yuqing; Wu, Qiong; Arnold, Jonathan; Becich, Michael J; Bisyuk, Yuriy; Blecker, Saul; Chrischilles, Elizabeth; Christakis, Dimitri A; Geary, Carol Reynolds; Jhaveri, Ravi; Lenert, Leslie; Liu, Mei; Mirhaji, Parsa; Morizono, Hiroki; Mosa, Abu S M; Onder, Ali Mirza; Patel, Ruby; Smoyer, William E; Taylor, Bradley W; Williams, David A; Dixon, Bradley P; Flynn, Joseph T; Gluck, Caroline; Harshman, Lyndsay A; Mitsnefes, Mark M; Modi, Zubin J; Pan, Cynthia G; Patel, Hiren P; Verghese, Priya S; Forrest, Christopher B; Denburg, Michelle R; Chen, Yong; ,
IMPORTANCE/UNASSIGNED:It remains unclear whether children and adolescents with SARS-CoV-2 infection are at heightened risk for long-term kidney complications. OBJECTIVE/UNASSIGNED:To investigate whether SARS-CoV-2 infection is associated with an increased risk of postacute kidney outcomes among pediatric patients, including those with preexisting kidney disease or acute kidney injury (AKI). DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This retrospective cohort study used data from 19 health institutions in the National Institutes of Health Researching COVID to Enhance Recovery (RECOVER) initiative from March 1, 2020, to May 1, 2023 (follow-up ≤2 years completed December 1, 2024; index date cutoff, December 1, 2022). Participants included children and adolescents (aged <21 years) with at least 1 baseline visit (24 months to 7 days before the index date) and at least 1 follow-up visit (28 to 179 days after the index date). EXPOSURES/UNASSIGNED:SARS-CoV-2 infection, determined by positive laboratory test results (polymerase chain reaction, antigen, or serologic) or relevant clinical diagnoses. A comparison group included children with documented negative test results and no history of SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Outcomes included new-onset chronic kidney disease (CKD) stage 2 or higher or CKD stage 3 or higher among those without preexisting CKD; composite kidney events (≥50% decline in estimated glomerular filtration rate [eGFR], eGFR ≤15 mL/min/1.73 m2, dialysis, transplant, or end-stage kidney disease diagnosis), and at least 30%, 40%, or 50% eGFR decline among those with preexisting CKD or acute-phase AKI. Hazard ratios (HRs) were estimated using Cox proportional hazards regression models with propensity score stratification. RESULTS/UNASSIGNED:Among 1 900 146 pediatric patients (487 378 with and 1 412 768 without COVID-19), 969 937 (51.0%) were male, the mean (SD) age was 8.2 (6.2) years, and a range of comorbidities was represented. SARS-CoV-2 infection was associated with higher risk of new-onset CKD stage 2 or higher (HR, 1.17; 95% CI, 1.12-1.22) and CKD stage 3 or higher (HR, 1.35; 95% CI, 1.13-1.62). In those with preexisting CKD, COVID-19 was associated with an increased risk of composite kidney events (HR, 1.15; 95% CI, 1.04-1.27) at 28 to 179 days. Children with acute-phase AKI had elevated HRs (1.29; 95% CI, 1.21-1.38) at 90 to 179 days for composite outcomes. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this large US cohort study of children and adolescents, SARS-CoV-2 infection was associated with a higher risk of adverse postacute kidney outcomes, particularly among those with preexisting CKD or AKI, suggesting the need for vigilant long-term monitoring.
PMCID:11992607
PMID: 40214993
ISSN: 2574-3805
CID: 5824322
Approach to Estimating Adherence to Heart Failure Medications Using Linked Electronic Health Record and Pharmacy Data
Blecker, Saul; Zhao, Yunan; Li, Xiyue; Kronish, Ian M; Mukhopadhyay, Amrita; Stokes, Tyrel; Adhikari, Samrachana
BACKGROUND:Medication non-adherence, which is common in chronic diseases such as heart failure, is often estimated using proportion of days covered (PDC). PDC is typically calculated using medication fill information from pharmacy or insurance claims data, which lack information on when medications are prescribed. Many electronic health records (EHRs) have prescription and pharmacy fill data available, enabling enhanced PDC assessment that can be utilized in routine clinical care. OBJECTIVE:To describe our approach to calculating PDC using linked EHR-pharmacy data and to compare to PDC calculated using pharmacy-only data for patients with heart failure. METHODS:We performed a retrospective cohort study of adult patients with heart failure who were prescribed guideline-directed medical therapy (GDMT) and seen in a large health system. Using linked EHR-pharmacy data, we estimated medication adherence by PDC as the percent of days in which a patient possessed GDMT based on medication pharmacy fills over the number of days the prescription order was active. We also calculated PDC using pharmacy-only data, calculated as medications possessed over days with continued medication fills. We compared these two approaches for days observed and PDC using a paired t-test. RESULTS:Among 33,212 patients with heart failure who were prescribed GDMT, 2226 (6.7%) never filled their medications, making them unavailable in the assessment of PDC using pharmacy-only data (n = 30,995). Linked EHR-pharmacy data had slightly longer days observed for PDC assessment (164.7 vs. 163.4 days; p < 0.001) and lower PDC (78.5 vs. 90.6, p < 0.001) as compared to assessment using pharmacy-only data. CONCLUSIONS:Linked EHR-pharmacy data can be used to identify patients who never fill their prescriptions. Estimating adherence using linked EHR-pharmacy data resulted in a lower mean PDC as compared to estimates using pharmacy-only data.
PMID: 39585579
ISSN: 1525-1497
CID: 5803832
Efficacy of a Clinical Decision Support Tool to Promote Guideline-Concordant Evaluations in Patients With High-Risk Microscopic Hematuria: A Cluster Randomized Quality Improvement Project
Matulewicz, Richard S; Tsuruo, Sarah; King, William C; Nagler, Arielle R; Feuer, Zachary S; Szerencsy, Adam; Makarov, Danil V; Wong, Christina; Dapkins, Isaac; Horwitz, Leora I; Blecker, Saul
PURPOSE/UNASSIGNED:We aimed to determine whether implementation of clinical decision support (CDS) tool integrated into the electronic health record of a multisite academic medical center increased the proportion of patients with AUA "high-risk" microscopic hematuria (MH) who receive guideline concordant evaluations. MATERIALS AND METHODS/UNASSIGNED:We conducted a two-arm cluster randomized quality improvement project in which 202 ambulatory sites from a large health system were randomized to either have their physicians receive at time of test results an automated CDS alert for patients with "high-risk" MH with associated recommendations for imaging and cystoscopy (intervention) or usual care (control). Primary outcome was met if a patient underwent both imaging and cystoscopy within 180 days from MH result. Secondary outcomes assessed individual completion of imaging, cystoscopy, or placement of imaging orders. RESULTS/UNASSIGNED:= .09). CONCLUSIONS/UNASSIGNED:Implementing an electronic health record-integrated CDS tool to promote evaluation of patients with high-risk MH did not lead to improvements in patient completion of a full guideline-concordant evaluation. The development of an algorithm to trigger a CDS alert was demonstrated to be feasible and effective. Further multilevel assessment of barriers to evaluation is necessary to continue to improve the approach to evaluating high-risk patients with MH.
PMID: 39854625
ISSN: 1527-3792
CID: 5802662
Association Between Cardiometabolic Comorbidity Burden and Outcomes in Heart Failure
Hamo, Carine E; Li, Xiyue; Ndumele, Chiadi E; Mukhopadhyay, Amrita; Adhikari, Samrachana; Blecker, Saul
BACKGROUND:Cardiometabolic comorbidities such as obesity, diabetes, and hypertension are highly prevalent in heart failure (HF). We aimed to examine the association between severity of cardiometabolic comorbidities and hospitalization in patients with HF. METHODS: RESULTS: CONCLUSIONS:Greater cardiometabolic comorbidity burden was associated with increased risk of all-cause hospitalization in HF. This reinforces the role for targeting severely uncontrolled cardiometabolic comorbidities to reduce morbidity in HF.
PMID: 39846294
ISSN: 2047-9980
CID: 5783512
Glucagon-Like Peptide-1 Receptor Agonist and Sodium-Glucose Cotransporter 2 Inhibitor Prescriptions in Type 2 Diabetes by Kidney and Cardiovascular Disease
Mehta, Sneha S; Surapaneni, Aditya L; Pandit, Krutika; Xu, Yunwen; Horwitz, Leora; Blecker, Saul; Blum, Matthew F; Chang, Alexander R; Shin, Jung-Im; Grams, Morgan E
PMID: 39688374
ISSN: 1533-3450
CID: 5764342