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Clinical Decision Support for Hypertension Management in Chronic Kidney Disease: A Randomized Clinical Trial
Samal, Lipika; Kilgallon, John L; Lipsitz, Stuart; Baer, Heather J; McCoy, Allison; Gannon, Michael; Noonan, Sarah; Dunk, Ryan; Chen, Sarah W; Chay, Weng Ian; Fay, Richard; Garabedian, Pamela M; Wu, Edward; Wien, Matthew; Blecker, Saul; Salmasian, Hojjat; Bonventre, Joseph V; McMahon, Gearoid M; Bates, David W; Waikar, Sushrut S; Linder, Jeffrey A; Wright, Adam; Dykes, Patricia
IMPORTANCE/UNASSIGNED:Chronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death. OBJECTIVE/UNASSIGNED:To evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included. INTERVENTION/UNASSIGNED:The intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations. RESULTS/UNASSIGNED:The study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:These findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03679247.
PMID: 38466302
ISSN: 2168-6114
CID: 5669832
Association between visit frequency, continuity of care, and pharmacy fill adherence in heart failure patients
Hamo, Carine E; Mukhopadhyay, Amrita; Li, Xiyue; Zheng, Yaguang; Kronish, Ian M; Chunara, Rumi; Dodson, John; Adhikari, Samrachana; Blecker, Saul
BACKGROUND:Despite advances in medical therapy for heart failure with reduced ejection fraction (HFrEF), major gaps in medication adherence to guideline-directed medical therapies (GDMT) remain. Greater continuity of care may impact medication adherence and reduced hospitalizations. METHODS:We conducted a cross-sectional study of adults with a diagnosis of HF and EF ≤40% with ≥2 outpatient encounters between January 1, 2017 and January 10, 2021, prescribed ≥1 of the following GDMT: 1) Beta Blocker, 2) Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker/Angiotensin Receptor Neprilysin Inhibitor, 3) Mineralocorticoid Receptor Antagonist, 4) Sodium Glucose Cotransporter-2 Inhibitor. Continuity of care was calculated using the Bice-Boxerman Continuity of Care Index (COC) and the Usual Provider of Care (UPC) index, categorized by quantile. The primary outcome was adherence to GDMT, defined as average proportion of days covered ≥80% over 1 year. Secondary outcomes included all-cause and HF hospitalization at 1-year. We performed multivariable logistic regression analyses adjusted for demographics, insurance status, comorbidity index, number of visits and neighborhood SES index. RESULTS:Overall, 3,971 individuals were included (mean age 72 years (SD 14), 71% male, 66% White race). In adjusted analyses, compared to individuals in the highest COC quartile, individuals in the third COC quartile had higher odds of GDMT adherence (OR 1.26, 95% CI 1.03-1.53, P = .024). UPC tertile was not associated with adherence (all P > .05). Compared to the highest quantiles, the lowest UPC and COC quantiles had higher odds of all-cause (UPC: OR 1.53, 95%CI 1.23-1.91; COC: OR 2.54, 95%CI 1.94-3.34) and HF (UPC: OR 1.81, 95%CI 1.23-2.67; COC: OR 1.77, 95%CI 1.09-2.95) hospitalizations. CONCLUSIONS:Continuity of care was not associated with GDMT adherence among patients with HFrEF but lower continuity of care was associated with increased all-cause and HF-hospitalizations.
PMID: 38621576
ISSN: 1097-6744
CID: 5657402
Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care
Mukhopadhyay, Amrita; Reynolds, Harmony R; King, William C; Phillips, Lawrence M; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Klapheke, Nathan; Katz, Stuart D; Horwitz, Leora I; Blecker, Saul
BACKGROUND:Electronic health record (EHR) tools can improve prescribing of guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF), but their effectiveness may vary by physician workload. OBJECTIVES/OBJECTIVE:This paper aims to assess whether physician workload modifies the effectiveness of EHR tools for HFrEF. METHODS:This was a prespecified subgroup analysis of the BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce Cardiovascular Recommendations for Heart Failure) cluster-randomized trial, which compared effectiveness of an alert vs message vs usual care on prescribing of mineralocorticoid antagonists (MRAs). The trial included adults with HFrEF seen in cardiology offices who were eligible for and not prescribed MRAs. Visit volume was defined at the cardiologist-level as number of visits per 6-month study period (high = upper tertile vs non-high = remaining). Analysis at the patient-level used likelihood ratio test for interaction with log-binomial models. RESULTS:Among 2,211 patients seen by 174 cardiologists, 932 (42.2%) were seen by high-volume cardiologists (median: 1,853; Q1-Q3: 1,637-2,225 visits/6 mo; and median: 10; Q1-Q3: 9-12 visits/half-day). MRA was prescribed to 5.5% in the high-volume vs 14.8% in the non-high-volume groups in the usual care arm, 10.3% vs 19.6% in the message arm, and 31.2% vs 28.2% in the alert arm, respectively. Visit volume modified treatment effect (P for interaction = 0.02) such that the alert was more effective in the high-volume group (relative risk: 5.16; 95% CI: 2.57-10.4) than the non-high-volume group (relative risk: 1.93; 95% CI: 1.29-2.90). CONCLUSIONS:An EHR-embedded alert increased prescribing by >5-fold among patients seen by high-volume cardiologists. Our findings support use of EHR alerts, especially in busy practice settings. (Building Electronic Tools to Enhance and Reinforce Cardiovascular Recommendations for Heart Failure [BETTER CARE-HF]; NCT05275920).
PMID: 38043045
ISSN: 2213-1787
CID: 5597482
A Dynamic Clinical Decision Support Tool to Improve Primary Care Outcomes in a High-Volume, Low-Resource Setting
Dapkins, Isaac; Prescott, Rasheda; Ladino, Nathalia; Anderman, Judd; McCaleb, Chase; Colella, Doreen; Gore, Radhika; Fontil, Valy; Szerencsy, Adam; Blecker, Saul
The Family Health Centers at New York University Langone (FHC), a federally qualified health center network in New York City, created a novel clinical decision support (CDS) tool that alerts primary health care providers to patients"™ gaps in care and triggers a dynamic, individualized order set on the basis of unique patient factors, enabling providers to readily act on each patient"™s specific gaps in care. FHC implemented this tool in 2017, starting with 15 protocols for quality measures; as of February 2024, there are 30 such protocols. During a patient visit with a provider, when there is a gap in care, a best-practice alert (BPA) fires, which includes an order set unique to the patient and visit. The provider can bypass the alert (not open it) or acknowledge the alert (open it). The provider may review the content of the order set and accept it as is or with modifications, or they can decline its recommendations if they believe it is not appropriate or plan to address the gap in care another way during the visit. To accept the dynamic order set is the intended workflow. The authors present data from September 2019 to January 2023 totaling 171,319 patient visits with at least one open gap in care among providers in pediatrics, family medicine, and internal medicine. The rate at which providers acknowledged the BPA in the first 6 months was 45% and steadily increased. In the last 6 months of the period, providers acknowledged the BPA 78% (19,281 of 24,575) of the time. Similarly, in the first 6 months, in all encounters in which a BPA was fired, 28.8% (8,585 of 29,829) had an order placed via the dynamic order set (accepted); that rate increased to 49.7% (12,210 of 24,575) during the last 6 months. This order set completion rate is notable given that most CDS use rates are low. Gap closure was higher when providers acknowledged the alert. In an analysis of all encounters with at least one open gap, spanning 2019"“2023, 46% (48,431 of 105,371) of the time, at least one gap was closed when the alert was acknowledged compared with 33% (21,993 of 65,948) when the alert was bypassed (and the recommendations of the dynamic order set were never followed). The authors show that CDS tools can be successfully implemented in a high-volume, low-resource setting if designed with efficiency in mind, ensuring provider utilization and clinical impact through closing care gaps. CDS tools that are dynamically patient specific can help improve quality of care if they are part of a broader culture of quality improvement.
SCOPUS:85190307342
ISSN: 2642-0007
CID: 5670482
Generative Artificial Intelligence to Transform Inpatient Discharge Summaries to Patient-Friendly Language and Format
Zaretsky, Jonah; Kim, Jeong Min; Baskharoun, Samuel; Zhao, Yunan; Austrian, Jonathan; Aphinyanaphongs, Yindalon; Gupta, Ravi; Blecker, Saul B; Feldman, Jonah
IMPORTANCE/UNASSIGNED:By law, patients have immediate access to discharge notes in their medical records. Technical language and abbreviations make notes difficult to read and understand for a typical patient. Large language models (LLMs [eg, GPT-4]) have the potential to transform these notes into patient-friendly language and format. OBJECTIVE/UNASSIGNED:To determine whether an LLM can transform discharge summaries into a format that is more readable and understandable. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This cross-sectional study evaluated a sample of the discharge summaries of adult patients discharged from the General Internal Medicine service at NYU (New York University) Langone Health from June 1 to 30, 2023. Patients discharged as deceased were excluded. All discharge summaries were processed by the LLM between July 26 and August 5, 2023. INTERVENTIONS/UNASSIGNED:A secure Health Insurance Portability and Accountability Act-compliant platform, Microsoft Azure OpenAI, was used to transform these discharge summaries into a patient-friendly format between July 26 and August 5, 2023. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Outcomes included readability as measured by Flesch-Kincaid Grade Level and understandability using Patient Education Materials Assessment Tool (PEMAT) scores. Readability and understandability of the original discharge summaries were compared with the transformed, patient-friendly discharge summaries created through the LLM. As balancing metrics, accuracy and completeness of the patient-friendly version were measured. RESULTS/UNASSIGNED:Discharge summaries of 50 patients (31 female [62.0%] and 19 male [38.0%]) were included. The median patient age was 65.5 (IQR, 59.0-77.5) years. Mean (SD) Flesch-Kincaid Grade Level was significantly lower in the patient-friendly discharge summaries (6.2 [0.5] vs 11.0 [1.5]; P < .001). PEMAT understandability scores were significantly higher for patient-friendly discharge summaries (81% vs 13%; P < .001). Two physicians reviewed each patient-friendly discharge summary for accuracy on a 6-point scale, with 54 of 100 reviews (54.0%) giving the best possible rating of 6. Summaries were rated entirely complete in 56 reviews (56.0%). Eighteen reviews noted safety concerns, mostly involving omissions, but also several inaccurate statements (termed hallucinations). CONCLUSIONS AND RELEVANCE/UNASSIGNED:The findings of this cross-sectional study of 50 discharge summaries suggest that LLMs can be used to translate discharge summaries into patient-friendly language and formats that are significantly more readable and understandable than discharge summaries as they appear in electronic health records. However, implementation will require improvements in accuracy, completeness, and safety. Given the safety concerns, initial implementation will require physician review.
PMID: 38466307
ISSN: 2574-3805
CID: 5678332
Health Information Technology Supporting Adherence Memory Disorder Patients: A Systematic Literature Review
Elkefi, Safa; Blecker, Saul; Bitan, Yuval
BACKGROUND: People with memory disorders have difficulty adhering to treatments. With technological advances, it remains important to investigate the potential of health information technology (HIT) in supporting medication adherence among them. OBJECTIVES/OBJECTIVE: This review investigates the role of HIT in supporting adherence to medication and therapies among patients with memory issues. It also captures the factors that impact technology adherence interventions. METHODS: We searched the literature for relevant publications published until March 15, 2023, using technology to support adherence among patients with memory issues (dementia, Alzheimer's, amnesia, mild cognitive impairment, memory loss, etc.). The review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. We conducted a quality assessment of the papers following the Mixed Methods Appraisal Tool. RESULTS: Fifteen studies were included after carefully reviewing the 3,773 articles in the search. Methodological quality, as appraised, ranged from 80 to 100% with eight studies rated 100%. The studies overall did not have a high risk of bias. Thus, all of the 15 studies were included. Technologies investigated were classified into four groups based on their impact: therapeutic patient education, simplifying treatment regimens, early follow-up visits and short-term treatment goals, and reminder programs. Different technologies were used (automatic drug dispensers or boxes, mobile health-based interventions, game-based interventions, e-health-based interventions, patient portals, and virtual reality). The factors impacting patients' adherence to technology-based treatment and medication were clustered into human-computer interaction and integration challenges. CONCLUSION/CONCLUSIONS: This study contributes to the literature by classifying the technologies that supported medication adherence among patients with memory issues in four groups. It also explores and presents the possible limitations of existing solutions to drive future research in supporting care for people with memory disorders.
PMCID:10830240
PMID: 38295858
ISSN: 1869-0327
CID: 5627132
Cohort profile: a large EHR-based cohort with linked pharmacy refill and neighbourhood social determinants of health data to assess heart failure medication adherence
Adhikari, Samrachana; Mukhyopadhyay, Amrita; Kolzoff, Samuel; Li, Xiyue; Nadel, Talia; Fitchett, Cassidy; Chunara, Rumi; Dodson, John; Kronish, Ian; Blecker, Saul B
PURPOSE/OBJECTIVE:Clinic-based or community-based interventions can improve adherence to guideline-directed medication therapies (GDMTs) among patients with heart failure (HF). However, opportunities for such interventions are frequently missed, as providers may be unable to recognise risk patterns for medication non-adherence. Machine learning algorithms can help in identifying patients with high likelihood of non-adherence. While a number of multilevel factors influence adherence, prior models predicting non-adherence have been limited by data availability. We have established an electronic health record (EHR)-based cohort with comprehensive data elements from multiple sources to improve on existing models. We linked EHR data with pharmacy refill data for real-time incorporation of prescription fills and with social determinants data to incorporate neighbourhood factors. PARTICIPANTS/METHODS:Patients seen at a large health system in New York City (NYC), who were >18 years old with diagnosis of HF or reduced ejection fraction (<40%) since 2017, had at least one clinical encounter between 1 April 2021 and 31 October 2022 and active prescriptions for any of the four GDMTs (beta-blocker, ACEi/angiotensin receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitor (SGLT2i)) during the study period. Patients with non-geocodable address or outside the continental USA were excluded. FINDINGS TO DATE/RESULTS:Among 39 963 patients in the cohort, the average age was 73±14 years old, 44% were female and 48% were current/former smokers. The common comorbid conditions were hypertension (77%), cardiac arrhythmias (56%), obesity (33%) and valvular disease (33%). During the study period, 33 606 (84%) patients had an active prescription of beta blocker, 32 626 (82%) had ACEi/ARB/ARNI, 11 611 (29%) MRA and 7472 (19%) SGLT2i. Ninety-nine per cent were from urban metropolitan areas. FUTURE PLANS/UNASSIGNED:We will use the established cohort to develop a machine learning model to predict medication adherence, and to support ancillary studies assessing associates of adherence. For external validation, we will include data from an additional hospital system in NYC.
PMCID:10693878
PMID: 38040431
ISSN: 2044-6055
CID: 5590482
Neighborhood-Level Socioeconomic Status and Prescription Fill Patterns Among Patients With Heart Failure
Mukhopadhyay, Amrita; Blecker, Saul; Li, Xiyue; Kronish, Ian M; Chunara, Rumi; Zheng, Yaguang; Lawrence, Steven; Dodson, John A; Kozloff, Sam; Adhikari, Samrachana
IMPORTANCE/UNASSIGNED:Medication nonadherence is common among patients with heart failure with reduced ejection fraction (HFrEF) and can lead to increased hospitalization and mortality. Patients living in socioeconomically disadvantaged areas may be at greater risk for medication nonadherence due to barriers such as lower access to transportation or pharmacies. OBJECTIVE/UNASSIGNED:To examine the association between neighborhood-level socioeconomic status (nSES) and medication nonadherence among patients with HFrEF and to assess the mediating roles of access to transportation, walkability, and pharmacy density. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This retrospective cohort study was conducted between June 30, 2020, and December 31, 2021, at a large health system based primarily in New York City and surrounding areas. Adult patients with a diagnosis of HF, reduced EF on echocardiogram, and a prescription of at least 1 guideline-directed medical therapy (GDMT) for HFrEF were included. EXPOSURE/UNASSIGNED:Patient addresses were geocoded, and nSES was calculated using the Agency for Healthcare Research and Quality SES index, which combines census-tract level measures of poverty, rent burden, unemployment, crowding, home value, and education, with higher values indicating higher nSES. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Medication nonadherence was obtained through linkage of health record prescription data with pharmacy fill data and was defined as proportion of days covered (PDC) of less than 80% over 6 months, averaged across GDMT medications. RESULTS/UNASSIGNED:Among 6247 patients, the mean (SD) age was 73 (14) years, and majority were male (4340 [69.5%]). There were 1011 (16.2%) Black participants, 735 (11.8%) Hispanic/Latinx participants, and 3929 (62.9%) White participants. Patients in lower nSES areas had higher rates of nonadherence, ranging from 51.7% in the lowest quartile (731 of 1086 participants) to 40.0% in the highest quartile (563 of 1086 participants) (P < .001). In adjusted analysis, patients living in the lower 2 nSES quartiles had significantly higher odds of nonadherence when compared with patients living in the highest nSES quartile (quartile 1: odds ratio [OR], 1.57 [95% CI, 1.35-1.83]; quartile 2: OR, 1.35 [95% CI, 1.16-1.56]). No mediation by access to transportation and pharmacy density was found, but a small amount of mediation by neighborhood walkability was observed. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this retrospective cohort study of patients with HFrEF, living in a lower nSES area was associated with higher rates of GDMT nonadherence. These findings highlight the importance of considering neighborhood-level disparities when developing approaches to improve medication adherence.
PMCID:10722333
PMID: 38095897
ISSN: 2574-3805
CID: 5589372
Evaluating Whether an Inpatient Initiative to Time Lab Draws in the Evening Reduces Anemia
Zaretsky, Jonah; Eaton, Kevin P; Sonne, Christopher; Zhao, Yunan; Jones, Simon; Hochman, Katherine; Blecker, Saul
BACKGROUND:Hospital acquired anemia is common during admission and can result in increased transfusion and length of stay. Recumbent posture is known to lead to lower hemoglobin measurements. We tested to see if an initiative promoting evening lab draws would lead to higher hemoglobin measurements due to more time in upright posture during the day and evening. METHODS:We included patients hospitalized on 2 medical units, beginning March 26, 2020 and discharged prior to January 25, 2021. On one of the units, we implemented an initiative to have routine laboratory draws in the evening rather than the morning starting on August 26, 2020. There were 1217 patients on the control unit and 1265 on the intervention unit during the entire study period. First we used a linear mixed-effects model to see if timing of blood draw was associated with hemoglobin level in the pre-intervention period. We then compared levels of hemoglobin before and after the intervention using a difference-in-difference analysis. RESULTS:In the pre-intervention period, evening blood draws were associated with higher hemoglobin compared to morning (0.28; 95% CI, 0.22-0.35). Evening blood draws increased with the intervention (10.3% vs 47.9%, P > 0.001). However, the intervention floor was not associated with hemoglobin levels in difference-in-difference analysis (coefficient of -0.15; 95% CI, -0.51-0.21). CONCLUSIONS:While evening blood draws were associated with higher hemoglobin levels, an intervention that successfully changed timing of routine labs to the evening did not lead to an increase in hemoglobin levels.
PMID: 37478815
ISSN: 2576-9456
CID: 5536212
Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
Blecker, Saul; Schoenthaler, Antoinette; Martinez, Tiffany Rose; Belli, Hayley M; Zhao, Yunan; Wong, Christina; Fitchett, Cassidy; Bearnot, Harris R; Mann, Devin
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/BACKGROUND:ClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/47930.
PMCID:10362494
PMID: 37418304
ISSN: 1929-0748
CID: 5539452