Medication Intensification Research Articles

Abstract P114: Reducing Racial Disparities in Hypertension Control using Multicomponent, Equity-Centered Approach

Background: Black Americans have the highest prevalence of hypertension among all racial or ethnic groups in the United States and are five times more likely to die from hypertension compared to non-Hispanic whites. Perceived discrimination in healthcare, clinician and institutional bias, and socioeconomic and environmental inequities contribute to uncontrolled hypertension in this population. Multilevel, multicomponent interventions have effectively improved blood pressure control among Black Americans but remain inadequately implemented in the clinical setting. An integrated nursing/public health quality improvement study was designed to address this gap between evidence and integration into clinical practice. Methods: Using a one group pre/posttest design, we examined the effect of a 12-week intervention on blood pressure among Black Americans with uncontrolled hypertension aged 18 and older in the primary care setting. Intervention components included remote blood pressure monitoring, weekly phone coaching with culturally congruent care, medication intensification, and a standardized hypertension protocol. Results: The average age of the participants (n=35) was 64 years, and two thirds (n=23) were female (66%). The mean difference in both systolic and diastolic blood pressure decreased significantly (23 mmHg and 11mmHg, t-test –9.736 and –5.502, p-value <.001). At 12 weeks, 87% of participants had achieved blood pressure control. The intervention also significantly improved medication adherence and hypertension knowledge (p-value <.001). Conclusion: A multicomponent, culturally congruent quality improvement intervention significantly improved blood pressure among Black Americans. Implications: Scaled up implementation of multicomponent, equity-centered, culturally congruent approaches are needed to reduce racial disparities in hypertension control.

Abstract MP12: Reproducibility of White Coat Hypertension and White Coat Uncontrolled Hypertension Among U.S. Adults

White coat hypertension (WCH) and white coat uncontrolled hypertension (WUCH) are phenomenon characterized by uncontrolled office blood pressures (BP) in the presence of normal out-of-office BPs among untreated and treated individuals, respectively. Although prior studies have investigated the reproducibility of WCH and WUCH, they were mainly limited to non-U.S. adults. We assessed white coat status in 272 (75% treated) adults with elevated office BP(≥130/80 mmHg) who had home BP (HBP) measurements for three consecutive months without initiation or intensification of antihypertensive medications during the three-month time interval of interest. HBP measurements were included only when number of readings were ≥12/month. WCH and WUCH was defined as HBP≤130/80 mmHg in untreated and treated adults, respectfully. The reproducibility was assessed using the Kappa coefficient (K) with 95% confidence intervals (CI). Mean age was 76±5 years (57% women, 12% Black adults). WCH was found in 39 of the 68 untreated adults with elevated office BP. WCH adults had an average home BP of 118/72±8/5 mmHg after the initial month of HBP monitoring (HBPM). As shown in Figure 1 , 87% and 85% had WCH status confirmed on repeat assessment after an additional one- and two-month interval of HBPM (K=0.54 and 0.48, respectfully). WUCH was found in 92 of the 204 treated adults with elevated office BP and had an average home BP of 120/71±5/5 mmHg. Of those, 86% and 84% had WUCH confirmed on repeat assessment after an additional one- and two-month interval of HBPM (K=0.65 and 0.52, respectfully). In conclusion, WCH and WUCH phenotypes when assessed by home blood pressure monitoring exhibited fair-to-moderate reproducibility among U.S. adults.

Abstract P316: Beyond the Cuff: Revolutionizing Hypertension Care through Human-Centered Design and Tech-Driven Solutions in an Urban Community Health Center

Community Health Centers serve populations burdened with cardiovascular disease due to social determinants of health, necessitating innovative solutions in resource-limited environments. Wi-Fi/Bluetooth-enabled home blood pressure monitors have emerged as clinical tools for diagnosing, monitoring, and managing hypertension. The real time data enables timely interventions by care teams of patients being monitored. A multifaceted approach beyond clinic settings, supported by digital tools, can help reduce healthcare costs by preventing avoidable emergency room visits. We posited that implementing a self-monitored blood pressure (SMBP) program, supplemented by holistic, human-centered patient coaching and feedback, in a community health center setting would enhance patient engagement, medication adherence, and hypertension control. We designed and piloted a small SMBP program using Bluetooth-enabled blood pressure devices, targeting adult patients with documented uncontrolled blood pressure seen in our health centers in a 6- month window. This was further augmented by a holistic, human-centered individual and group-level coaching session. Patients enrolled in the SMBP program received comprehensive education on hypertension, including medication management and lifestyle changes, as well as data-driven feedback on their blood pressure profiles during virtual group and individual outreach sessions. The program's goals were to increase patient engagement in their care, adherence to interventions, leading to better blood pressure control. Results were significant: 22 of 32 participants graduated, achieving improved blood pressure control with medication and lifestyle changes. Average reductions of 17 mmHg in systolic and 6 mmHg in diastolic blood pressure were noted after being in the program for an average of three months. Among the graduates, 50% required medication intensification, and 60% adopted lifestyle changes, indicating the program's effectiveness. Our pilot affirmed the efficacy of utilizing digital solutions and integrated strategies to improve hypertension control and empower patients to make timely changes with data feedback. The key findings from our pilot led to the expansion of the SMBP program to serve a larger cohort of patients in our clinic. This underscores the critical role of patient engagement, technology integration, and an integrated approach to care in improving hypertension management, particularly in underserved communities.

Association of multimorbidity with guideline-directed medical therapy intensification in heart failure: Findings from the EPIC-HF trial

A potential contributor to the suboptimal rates of guideline directed medical therapy (GDMT) prescribing for heart failure with reduced ejection fraction (HFrEF) is the burden of multimorbidity in patients with HFrEF. We examined the effect of multimorbidity on GDMT prescription in the EPIC-HF trial, finding that multimorbidity was associated with decreased likelihood of GDMT intensification. Further study is needed to guide treatment in high-risk, multimorbid patients with HFrEF.

Efficacy of the Cardiac Implantable Electronic Device Multisensory Triage-HF Algorithm in Heart Failure Care: A Real-World Clinical Experience.

Heart failure (HF) admissions are burdensome, and the mainstay of prevention is the timely detection of impending fluid retention, creating a window for medical treatment intensification. This study evaluated the accuracy and performance of a Triage-HF-guided carepath in real-world ambulatory HF patients in daily clinical practice. In this prospective, observational study, 92 adult HF patients (71 males (78%), with a median age of 69 [IQR 59-75] years) with the Triage-HF algorithm activated in their cardiac implantable electronic devices (CIEDs), were monitored. Following high-risk alerts, an HF nurse contacted patients to identify signs and symptoms of fluid retention. The sensitivity and specificity were 83% and 97%, respectively. The positive predictive value was 89%, and negative predictive value was 94%. The unexplained alert rate was 0.05 alerts/patient year, and the false negative rate was 0.11 alerts/patient year. Ambulatory diuretics were initiated or escalated in 77% of high-risk alert episodes. In 23% (n = 6), admission was ultimately required. The median alert handling time was 2 days. Fifty-eight percent (n = 18) of high-risk alerts were classified as true positives in the first week, followed by 29% in the second-third weeks (n = 9), and 13% (n = 4) in the fourth-sixth weeks. Common sensory triggers included an elevated night ventricular rate (84%), OptiVol (71%), and reduced patient activity (71%). The CIED-based Triage-HF algorithm-driven carepath enables the timely detection of impending fluid retention in a contemporary ambulatory setting, providing an opportunity for clinical action.

Therapeutic patient education and treatment intensification of diabetes and hypertension in subjects with newly diagnosed type 2 diabetes mellitus: a longitudinal study.

The aim of this study is to prospectively evaluate whether individual and group Therapeutic Patient Education (TPE) can reduce the need to intensify treatment of diabetes and hypertension in newly diagnosed type 2 diabetic patients. A total of 937 patients were recruited and followed-up for 42.7 ± 21.5 months. TPE was a structured comprehensive education delivered by trained nurses: 322 patients received individual TPE (ITPE), 291 underwent group TPE (GTPE), and 324 were in Usual Care (UC). The primary endpoints were intensification of diabetes treatment and intensification of hypertension treatment. The rate of diabetes treatment intensification was 40.1% in patients receiving ITPE, 47.8% in patients undergoing GTPE, and 64.2% in patients in UC (p < 0.001). The rate of hypertension treatment intensification was 24.2% in patients following ITPE, 31.3% in patients receiving GTPE, and 41.0% in patients in UC (p < 0.001). Multivariate analysis showed that both ITPE and GTPE were associated with reduced intensification of diabetes (ITPE: HR:0.51; 95% IC:0.40-0.64; p < 0.001 - GTPE: HR:0.46; 95% IC:0.44-0.70; p < 0.001) and hypertension medication (ITPE: HR:0.45; 95% IC:0.34-0.61; p < 0.001 - GTPE: HR:0.49; 95% IC:0.38-0.65; p < 0.001). The association was independent of age, sex, BMI, HbA1c, and presence of hypertension at baseline. TPE, delivered as both individual and group sessions, represents an effective tool to reduce the need to intensify treatment of both diabetes and hypertension. Therefore, it can ensure better control of diabetes and hypertension with fewer medications. This could reduce adverse effects and costs and improve quality of life and medication taking in patients with type 2 diabetes.

One size does not fit all: universal cuff overestimates oscillometric blood pressure in persons with large arm circumference

Objective Some brachial cuffs for oscillometric blood pressure (BP) measurement are claimed to cover a wide range of upper-arm circumferences; however, their validation is rarely conducted. Our aim was to compare oscillometric BP measurements obtained with a universal cuff with those obtained with an appropriately sized cuff. Methods We utilised the Microlife B6 Connect monitor, conducting oscillometric BP measurements in a random sequence with both a universal cuff (recommended for arm circumferences from 22 to 42 cm) and an appropriately sized cuff (medium for circumference 22–32 cm and large for 32–42 cm). We included 91 individuals with an arm circumference of 22–32 cm and 64 individuals with an arm circumference of 32–42 cm. Results For arm circumferences > 32 cm, systolic and diastolic BP measured with the universal cuff was higher than that measured with the large cuff (systolic 6.4 mmHg, 95% confidence interval [CI]). 3.9–8.8, diastolic 2.4 mmHg, 95%CI, 1.2–3.7, p < 0.001 for both). Overestimation of BP with the universal cuff was statistically significant after correcting for the sequence of measurements. No statistical difference was found between the universal cuff and medium cuff for circumferences in the 22–32 cm range. The bladder size in the universal cuff matched the dimensions of the medium-sized cuff; however, the cuff was larger. Conclusion Overestimation of BP measured with a universal cuff in persons with large arm circumferences is clinically important. It poses the risk of unnecessary initiation or intensification of antihypertensive medication in persons using the universal cuff.

Abstract P174: Food as Medicine: Evaluating the Effect of a Food Insecurity Intervention on Lipid-Lowering Prescription Medications

Introduction: Food insecurity and chronic diseases are interrelated challenges, as access to healthful food can hinder effective prevention and management of chronic diseases such as hyperlipidemia. ‘Food as Medicine’ programs that integrate food deliveries and behavioral interventions into healthcare have been recommended for addressing this challenge. While there is some evidence to support the benefits of these initiatives, there has been limited research to evaluate their effectiveness, especially on outcomes related to hyperlipidemia or lipid medication utilization. Methods: This study utilized a quasi-experimental design, using propensity-score matching to compare participants enrolled in the Recipe4Health intervention (R4H) to a control group of participants in clinics where this intervention was not implemented. R4H included 12 weekly deliveries of produce, with or without group medical visits (GMV) with 12 weekly sessions. We examined whether R4H was associated with a change in the intensity of participants’ prescribed regimens. Patient prescriptions for statins as well as any other prescription medications and relevant supplements were assessed. Regimens were standardized to assess whether if a patient’s daily prescribed regimen intensified (e.g. increased dose or added medications), de-intensified (e.g. decreased dose and/or removed medications), or demonstrated no change. Two outcome measures were defined, Overall Regimen Change and Statin-specific Change. Adult participants were included, excluding pregnant women. Generalized linear mixed models were used assuming a multinomial distribution for the outcomes separately for the categories. Results: Patients who took part in the R4H with GMV were more likely to have a medication regimen intensification compared to controls (28.2% vs. 21%, p=0.05). Although not significant, there was a trend of greater reduction in overall medication regimen among patients who participated in R4H with GMV compared to controls ( 6.1/5.2% vs. 1.4%). There was a non-significant trend of reduction in medication among patients in Food Farmacy with GMV/without GMV alone compared to controls for the statin potency change outcome (1.2/3.2% vs 0%), whereas the trend of medication intensification was comparable for all three groups. Conclusion: These results indicate that the group medical visit component of the R4H intervention may have increased patient engagement with medical services, thus resulting intensified medication regimen.

Immediate pharmacotherapy intensification after cardiac resynchronization therapy: incidence, characteristics, and impact.

Cardiac resynchronization therapy (CRT) is an established treatment for drug-refractory heart failure (HF) in patients with left bundle branch block (LBBB). Acute haemodynamic improvement after CRT implantation may enable the intensification of HF medication soon thereafter. Immediate pharmacotherapy intensification (IPI) after CRT implantation achieves a synergetic effect, possibly leading to a better prognosis. This study aimed to explore the incidence, characteristics, and impact of IPI on real-world outcomes among CRT recipients with a history of hospitalization for acute HF. This multicentre retrospective study enrolled CRT recipients with LBBB morphology, a QRS width ≥120ms, a left ventricular ejection fraction ≤35%, and New York Heart Association II-IV HF symptoms. All patients had previous HF hospitalizations within the previous year and received guideline-directed medical therapy before CRT implantation. Patient baseline characteristics, including HF medication, were collected. IPI was defined as the intensification of beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and mineralocorticoid receptor antagonists within 30days of CRT implantation. The primary endpoint was all-cause death or first hospitalization for HF; the secondary endpoint was all-cause death. We enrolled 194 patients (75% male; mean age, 65±13years; 78% with non-ischaemic cardiomyopathy). One hundred five (54%) patients received IPI. Patients who received IPI exhibited a significantly shorter QRS duration (159±26 vs. 171±32ms; P=0.004), higher estimated glomerular filtration rate (55.2±20.0 vs. 47.8±24.7mL/min/1.73m2; P=0.022), and more dilated cardiomyopathy. During a median follow-up period of 29months, 70 (36%) patients reached the primary endpoint and 42 (22%) patients died. Patients with IPI showed significantly better outcomes for the primary and secondary endpoints than patients without IPI. The volumetric responder ratio at 6months after implantation was not significantly different between patients with and without IPI; however, patients who received IPI had reduced mortality even at 6months after implantation. In the multivariate analysis, IPI was an independent predictor of the primary endpoint (hazard ratio, 0.51; 95% confidence interval, 0.27-0.97; P=0.043). Immediate intensification of HF medication was achieved in 54% of CRT recipients and was significantly higher in patients without excessive QRS prolongation, preserved renal function, and dilated cardiomyopathy than others. In patients with LBBB morphology and QRS≥120ms, IPI was associated with a significantly better prognosis and fewer HF hospitalizations after CRT implantation than others.

Deintensification of potentially inappropriate medications amongst older frail people with type 2 diabetes: Protocol for a cluster randomised controlled trial (D-MED study)

AimsAmongst elderly people with type 2 diabetes (T2D) over prescribing can result in emergency ambulance call-outs, falls and fractures and increased mortality, particularly in frail patients. Current clinical guidelines, however, remain focused on medication intensification rather than deintensification where appropriate. This study aims to evaluate the effectiveness of an electronic decision-support system and training for the deintensification of potentially inappropriate medications amongst older frail people with T2D, when compared to ‘usual’ care at 12-months. MethodsThis study is an open-label, multi-site, two-armed pragmatic cluster-randomised trial. GP practices randomised to the ‘enhanced care’ group have an electronic decision support system installed and receive training on the tool and de-intensification of diabetes medications. The system flags eligible patients for possible deintensification of diabetes medications, linking the health care professional to a clinical algorithm. The primary outcome will be the number of patients at 12-months who have had potentially inappropriate diabetes medications de-intensified. ResultsStudy recruitment commenced in June 2022. Data collection commenced in January 2023. Baseline data have been extracted from 40 practices (3145 patients). ConclusionsDigital technology, involving computer decision systems, may have the potential to reduce inappropriate medications and aid the process of de-intensification. Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN53221378. Available at: https://www.isrctn.com/ISRCTN53221378.

Effectiveness of Hypertension Management Strategies in SPRINT-Eligible US Adults: ASimulation Study.

Despite reducing cardiovascular disease (CVD) events and death in SPRINT (Systolic Blood Pressure Intervention Trial), intensive systolic blood pressure goals have not been adopted in the United States. This study aimed to simulate the potential long-term impact of 4 hypertension management strategies in SPRINT-eligible US adults. The validated Blood Pressure Control-Cardiovascular Disease Policy Model, a discrete event simulation of hypertension care processes (ie, visit frequency, blood pressure [BP] measurement accuracy, medication intensification, and medication adherence) and CVD outcomes, was populated with 25 000 SPRINT-eligible US adults. Four hypertension management strategies were simulated: (1) usual care targeting BP <140/90 mm Hg (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care), (2) intensive care per the SPRINT protocol targeting BP <120/90 mm Hg (SPRINT intensive), (3) usual care targeting guideline-recommended BP <130/80 mm Hg (American College of Cardiology/American Heart Association usual care), and (4) team-based care added to usual care and targeting BP <130/80 mm Hg. Relative to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, among the 18.1 million SPRINT-eligible US adults, an estimated 138 100 total CVD events could be prevented per year with SPRINT intensive, 33 900 with American College of Cardiology/American Heart Association usual care, and 89 100 with team-based care. Compared with the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, SPRINT intensive care was projected to increase treatment-related serious adverse events by 77 600 per year, American College of Cardiology/American Heart Association usual care by 33 300, and team-based care by 27 200. As BP control has declined in recent years, health systems must prioritize hypertension management and invest in effective strategies. Adding team-based care to usual care may be a pragmatic way to manage risk in this high-CVD-risk population.

Impact of medication intensification on 30-day hospital readmissions in a geriatric trauma population: A multicenter cohort study.

Fall-related injuries are a significant health issue that occur in 25% of older adults and account for a significant number of trauma-related hospitalizations. Although medication intensification may increase the risk of hospital readmissions in non-trauma patients, data on a geriatric trauma population are lacking. The primary objective was to evaluate the effect of medication intensification on 30-day hospital readmissions in geriatric patients hospitalized for fall-related injuries. This multicenter, retrospective cohort study included patients with geriatric who presented to one of three trauma centers within a large, health-system between January 1, 2018 and December 31, 2020. Patients at least 65 years old admitted with a fall-related injury were eligible for inclusion. Patients were grouped according to medication changes at discharge, which included intensified and non-intensified groups. Medication intensification included increased dose(s) or initiation of new agents. The primary outcome was the 30-day hospital readmission rate. Of the 870 patients included (median [interquartile range, IQR] age, 82 [74-89] years, 522 (60%) female, and 220 (25%) with a previous fall), there were 471 (54%) and 399 (46%) patients in the intensified and non-intensified groups, respectively. The intensified group had a higher 30-day hospital readmission rate (21% intensified vs. 16% non-intensified, p = 0.043; number needed to harm 20) based on an unweighted analysis. According to a weighted propensity score logistic regression, medication intensification was associated with higher 30-day hospital readmissions (24% [95% confidence interval [CI] 19-31%] intensified vs. 15% [95% CI 11-20%] non-intensified, p = 0.018). These results were consistent within competing risk models accounting for death (cause-specific model: hazard ratio [HR] 1.63 [95% CI 1.07-2.49], p = 0.023; Fine-Gray model: HR 1.64 [95% CI 1.07-2.50], p = 0.022). In a geriatric trauma population hospitalized after a fall, intensification of medications may pose an increased risk of 30-day hospital readmission.

Abstract 17197: Team-Based Care for Uncontrolled Hypertension in Accountable Care Organizations: A Simulation Study

Background and Objectives: Team-based care (TBC) is associated with greater blood pressure (BP) reductions than usual care, particularly when non-physicians titrate antihypertensive medications, but has yet to be widely adopted. This analysis projected the effectiveness of TBC among patients with uncontrolled hypertension from three accountable care organizations (ACOs): Columbia University Medical Center (New York), Cedars-Sinai Medical Center (California), and Ochsner Accountable Care Network (Louisiana). Methods: The Cardiovascular Disease (CVD) Policy Model is a computer model that simulates modifiable hypertension care processes (i.e., office visit frequency, BP measurement accuracy, medication intensification, and patient medication adherence) and has been validated to reproduce TBC outcomes. We used the CVD Policy Model to simulate the ACO population aged &gt;=65 years with BP &gt;=140/90 mmHg at two outpatient visits in 2015, and project BP and CVD outcomes out to 10 years with usual care alone vs. one year of TBC followed by a return to usual care. Hypertension usual care processes were derived from national sources and published literature. The model was calibrated to reproduce systolic BP reductions with TBC at one year vs. usual care from a published meta-analysis, which were stratified by the team member responsible for antihypertensive medication titration: -5.0 (95%CI -7.9, -2.2) mmHg with physician titration and -10.5 (95%CI -16.2, -4.8) mmHg with non-physician titration. Results: The ACO population with uncontrolled BP (N=9,788) had a mean (SD) age of 76.3 (7.8) years; 66.6% were white and 59.8% female. The mean BP (SD) at baseline was 151.1 (13.0)/78.1 (10.6) mmHg and 39.1% had a history of CVD. Compared with usual care at 10 years, TBC with non-physician titration was projected to increase the proportion with BP &lt;140/90 mmHg by 16.0% and TBC with physician titration by 4.2%. Relative to usual care, TBC with non-physician titration was projected to prevent 20.8 CVD events per 1000 individuals and TBC with physician titration to prevent 6.6 CVD events. Conclusion: Universal adoption of TBC, especially with non-physician titration, could improve achievement of quality benchmark BP control goals and prevent CVD events in ACO populations.

Abstract 14323: Significance of Angio-IMR to Predict Heart Failure Post-TAVI

Background/Introduction: The number of transcatheter aortic valve implantation (TAVI) procedures is currently increasing. However, a substantial number of patients suffer from repeated heart failure (HF) after the TAVI procedure. The association between Index of Microvascular Resistance (IMR) and HF is already known, especially in HFpEF. Purpose: The aim of this study was to assess the prognostic significance of IMR for HF after TAVI. Method and Result: 120 consecutive patients who underwent coronary angiography (CAG) before undergoing TAVI in our hospital between 2018 and 2021 were included in the analysis. Quantitative Flow Ratio (QFR) analysis was performed for each coronary artery, excluding cases undergoing PCI before or after TAVI. The angiography derived IMR was then obtained from the QFR values. Finally, 65 patients were available for IMR analysis. Of these, 12 were hospitalized or underwent medical intensification for HF exacerbations after TAVI. IMR was significantly higher in patients with HF compared without HF. (73.8 (31 to 121) vs 59.7 (26 to 153), p=0.041) No other significant differences were found in age, QFR values, EF, i-EOA on echocardiography after TAVI, STS score, and BNP values before TAVI. All patients with HF were female. Conclusion: It is suggested that angio-derived IMR values before TAVI might be a useful predictor of heart failure after TAVI.

Mobile Health Intervention in Patients With Type 2 Diabetes

Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. ClinicalTrials.gov Identifier: NCT02990299.

Clinical Inertia Among Outpatients With Heart Failure: Application of Treatment Nonintensification Taxonomy to EPIC-HF Trial

BackgroundThe contribution of clinical inertia to suboptimal guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) remains unclear. ObjectivesThis study examined reasons for GDMT nonintensification and characterized clinical inertia. MethodsIn this secondary analysis of EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction), a randomized clinical trial evaluating a patient-activation tool on GDMT utilization, we performed a sequential, explanatory mixed-methods study. Reasons for nonintensification among 4 medication classes were assigned according to an expanded published taxonomy using structured chart reviews. Audio transcripts of clinic encounters were analyzed to further characterize nonintensification reasons. Integration occurred during the interpretation phase. ResultsAmong 292 HFrEF patients who completed a cardiology visit, 185 (63.4%) experienced no treatment intensification, of whom 90 (48.6%) had at least 1 opportunity for intensification of a medication class with no documented contraindication or barriers (ie, clinical inertia). Nonintensification reasons varied by medication class, and included heightened risk of adverse effects (range 18.2%-31.6%), patient nonadherence (range 0.8%-1.1%), patient preferences and beliefs (range 0.6%-0.9%), comanagement with other providers (range 4.6%-5.6%), prioritization of other issues (range 15.6%-31.8%), multiple categories (range 16.5%-22.7%), and clinical inertia (range 22.7%-31.6%). A qualitative analysis of 32 clinic audio recordings demonstrated common characteristics of clinical inertia: 1) clinician review of medication regimens without education or intensification discussions; 2) patient stability as justification for nonintensification; and 3) shorter encounters for nonintensification vs intensification. ConclusionsIn this comprehensive study exploring HFrEF prescribing, clinical inertia is a main contributor to nonintensification within an updated taxonomy classification for suboptimal GDMT prescribing. This approach should help target strategies overcoming GDMT underuse.

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study

Remote patient monitoring (RPM) for hypertension enables automatic transmission of blood pressure (BP) and pulse into the electronic health record (EHR), but its effectiveness in primary care is unknown. This pragmatic matched cohort study using EHR data compared BP outcomes between individuals prescribed RPM and temporally-matched controls from six primary care practices. We retrospectively created a cohort of 288 Medicare-enrolled patients prescribed BP RPM (cases) and 1152 propensity score-matched controls (1:4). Matching was based on age, sex, systolic blood pressure (SBP), marital status, and other characteristics. Outcomes at 3, 6, 9 and 12 months were: controlling high BP (most recent BP < 140/90 mm Hg), antihypertensive medication intensification, and most recent SBP assessed using: all measurements, and office measurements only. At baseline, RPM-prescribed patients and controls had similar ages and systolic BP. BP control diverged at 3 months (RPM: 72.2%, control: 51%, p < 0.001). This difference persisted but decreased over follow-up. After 12 months, the RPM-prescribed cohort had greater BP control (RPM: 71.5%, control: 58.1%, p < 0.001) and lower SBP (132.3 versus 136.5 mm Hg, p = 0.003) using all measurements, but they did not differ using only office measurements (12 month BP control: 60.8% versus 58.1%, p = 0.44; SBP: 135.9 versus 136.5 mm Hg, p = 0.91). At 12 months, the most recent BP measurements were more current for RPM-prescribed patients (median [IQR] 8 [0–109] versus 134 [56–239] days). Net increases in antihypertensive medications by 12 months were similar. Implementation of RPM in primary care could inform hypertension management strategies and increase hypertension control. Registration: ClinicalTrials.gov identifier: NCT05562921.

Evidence for Age Bias Contributing to Therapeutic Inertia in Blood Pressure Management: A Secondary Analysis of SPRINT.

Despite evidence supporting the cardiovascular and cognitive benefits of intensive blood pressure management, older adults have the lowest rates of blood pressure control. We determined the association between age and therapeutic inertia (TI) in SPRINT (Systolic Blood Pressure Intervention Trial), and whether frailty, cognitive function, or gait speed moderate or mediate these associations. We performed a secondary analysis of SPRINT of participant visits with blood pressure above randomized treatment goal. We categorized baseline age as <60, 60 to <70, 70 to <80, and ≥80 years and TI as no antihypertensive medication intensification per participant visit. Generalized estimating equations generated odds ratios for TI associated with age, stratified by treatment group based on nested models adjusted for baseline frailty index score (fit [frailty index, ≤0.10], less fit [0.10<frailty index≤0.21], and frail [0.21<frailty index]), cognitive function by Montreal cognitive assessment, and gait speed (participants ≥75 years of age), separately. Participants 60 to <70, 70 to <80, and ≥80 years of age had a higher prevalence of TI in both treatment groups versus participants <60 years of age (standard: 59.7%, 60.5%, and 60.1% versus 56.0%; 29 527 participant visits; intensive: 55.1%, 57.2%, and 57.8% versus 53.8%; 47 129 participant visits). The adjusted odds ratios for TI comparing participants ≥80 versus <60 years of age were 1.32 (95% CI, 1.14-1.53) and 1.25 (95% CI, 1.11-1.41) in the standard and intensive treatment groups, respectively. Adjustment for frailty, cognitive function, or gait speed did not attenuate the association or demonstrate effect modification (all Pinteraction, >0.10). Older age is associated with greater TI independent of physical or cognitive function, implying age bias in hypertension management.

Genetic Testing Enables the Diagnosis of Familial Hypercholesterolemia Underdiagnosed by Clinical Criteria: Analysis of Japanese Early-Onset Coronary Artery Disease Patients.

Definitive diagnosis of familial hypercholesterolemia (FH) is paramount for the risk management of patients and their relatives. The present study aimed to investigate the frequency of gene variants contributing to low-density lipoprotein cholesterol (LDL-C) metabolism and their clinical relevance in patients with early-onset coronary artery disease (EOCAD). Among 63 consecutive patients with EOCAD (men <55 years or women <65 years) who underwent percutaneous coronary intervention (PCI) from 2013 to 2019 at Keio University Hospital, 52 consented to participate in this retrospective study. Targeted sequencing of LDLR, PCSK9, APOB, and LDLRAP1 was performed. Of the 52 patients enrolled (42 men; mean age: 50 ± 6 years), one (LDLR, c.1221_1222delCGinsT) harbored a pathogenic mutation, and one (APOB, c.10591A>G) harbored variants of uncertain significance. Both the patients harboring the variants were male, showing no history of diabetes mellitus or chronic kidney disease, no family history of EOCAD, and no physical findings of FH (i.e., tendon xanthomas or Achilles tendon thickening). Patients harboring the LDLR variant had three-vessel disease, were on a statin prescription at baseline, and had stable LDL-C levels; however, the case showed a poor response to the intensification of medication after PCI. Approximately 3.8% of patients with EOCAD harbored variants of gene related to LDL-C metabolism; there were no notable indicators in the patients' background or clinical course to diagnose FH. Given the difficulty in diagnosing FH based on clinical manifestations and family history, genetic testing could enable the identification of hidden risk factors and provide early warnings to their relatives.

Seasonal variation in blood pressure control across US health systems.

We aimed to characterize seasonal variation in US population-based blood pressure (BP) control and BP-related metrics and evaluate the association between outdoor temperature and BP control variation. We queried electronic health records (EHRs) from 26 health systems, representing 21 states, to summarize BP metrics by quarters of 12-month periods from January 2017 to March 2020. Patients with at least one ambulatory visit during the measurement period and a hypertension diagnosis during the first 6 months or prior to the measurement period were included. Changes in BP control, BP improvement, medication intensification, average SBP reduction after medication intensification across quarters and association with outdoor temperature were analyzed using weighted generalized linear models with repeated measures. Among 1 818 041 people with hypertension, the majority were more than 65 years of age (52.2%), female (52.1%), white non-Hispanic (69.8%) and had stage 1/2 hypertension (64.8%). Overall, BP control and process metrics were highest in quarters 2 and 3, and lowest in quarters 1 and 4. Quarter 2 had the highest percentage of improved BP (31.95 ± 0.90%) and average SBP reduction after medication intensification (16 ± 0.23 mmHg). Quarter 3 had the highest percentage of BP controlled (62.25 ± 2.55%) and lowest with medication intensification (9.73 ± 0.60%). Results were largely consistent in adjusted models. Average temperature was associated with BP control metrics in unadjusted models, but associations were attenuated following adjustment. In this large, national, EHR-based study, BP control and BP-related process metrics improved during spring/summer months, but outdoor temperature was not associated with performance following adjustment for potential confounders.