Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program.

BACKGROUND: In patients with or at risk for atherosclerotic vascular disease, statins reduce the incidence of major adverse cardiovascular events, but the majority of US adults with an indication for statin therapy are not prescribed statins at guideline-recommended intensity. Clinicians' limited time to address preventative care issues is cited as one factor contributing to gaps in statin prescribing. Centralized pharmacy services can fulfill a strategic role for population health management through outreach, education, and statin prescribing for patients at elevated ASCVD risk, but best practices for optimizing referrals of appropriate patients are unknown. STUDY DESIGN AND OBJECTIVES: SUPER LIPID (NCT05537064) is a program consisting of two pragmatic clinical trials testing the effect of nudges in increasing referrals of appropriate patients to a centralized pharmacy service for lipid management, conducted within 11 primary care practices in a large community health system. In both trials, patients were eligible for inclusion if they had an assigned primary care provider (PCP) in a participating practice and were not prescribed a high- or moderate-intensity statin despite an indication, identified via an electronic health record (EHR) algorithm. Trial #1 was a stepped wedge trial, conducted at a single practice with randomization at the PCP level, of an interruptive EHR message that appeared during eligible patients' visits and facilitated referral to the pharmacy service. For the first 3 months, no PCPs received the message; for the second 3 months, half were randomly selected to receive the message; and for the last 3 months, all PCPs received the message. Trial #2 was a cluster-randomized trial conducted at 10 practices, with randomization at the practice level. Practices were randomized to usual care or to have eligible patients automatically referred to centralized pharmacy services via a referral order placed in PCPs EHR inboxes for co-signature. In both trials, when a patient was referred to centralized pharmacy services, a pharmacist reviewed the patient's chart, contacted the patient, and initiated statin therapy if the patient agreed. The primary endpoint of both trials was the proportion of patients prescribed a statin; secondary endpoints include the proportion of patients prescribed a statin at guideline-recommended intensity, the proportion of patients filling a statin prescription, and serum low-density lipoprotein level. CONCLUSIONS: SUPER LIPID is a pair of pragmatic clinical trials assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized pharmacy service for lipid management. The trial results will develop the evidence base for simple, scalable, EHR-based strategies to integrate clinical pharmacists into population health management and increase appropriate statin prescribing. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov; NCT05537064.

Feasibility and outcomes from using a commitment device and text message reminders to increase adherence to time-restricted eating: A randomized trial.

BACKGROUND: Obesity is strongly associated with cardiovascular disease, particularly through its effects on blood pressure. Though maintaining a negative caloric balance leads to weight loss, many patients struggle to adhere to low calorie diets over the long term. Time-restricted eating, a subtype of intermittent fasting (IF), may be an easier dietary pattern for patients to initiate and maintain. We tested the feasibility of a bidirectional texting strategy to help patients with obesity and hypertension initiate and maintain time-restricted eating, and whether a commitment device, a pledge to behave in a certain way in the future while making nonadherence costlier, would increase adherence beyond bidirectional texting. METHODS: Patients with obesity and hypertension seen in cardiology clinics were provided education on time-restricted eating and randomized to a commitment device versus attention control. Attention control consisted of daily bidirectional text messages asking whether patients adhered to IF and weekly text messages asking participants to send their weight and blood pressure. The commitment device involved the same text messages as attention control, plus a commitment contract, setting of implementation intentions with respect to details of time-restricted eating, and involvement of a support partner who received weekly updates on the participant's adherence to time-restricted eating. The intervention lasted 12 weeks, followed by a 6-week follow-up period. The primary outcome was days per week adherent to time-restricted eating over the 18-week study period, measured by daily self-report. We also compared change from baseline weight and blood pressure between randomized groups. RESULTS: A total of 37 patients were randomized and started the study-20 to attention control and 17 to the commitment device. Mean age was 60 years old, and mean BMI was 38.4 kg/m2. Over the 18-week study period, the mean ± standard deviation (SD) number of days per week adherent to time-restricted eating was 4.7 ± 1.9 in the control arm and 5.4 ± 1.7 in the intervention arm (P = .23). Mean systolic blood pressure declined from 135 to 128 mm Hg among all participants (P = .006) with no difference between groups in change from baseline blood pressure (P = .74). Weight decreased from 229 to 223 pounds among all participants (P = .25) with no significant difference between groups in change from baseline weight (P = .84). CONCLUSIONS: A bidirectional texting strategy was feasible for helping patients with obesity and hypertension initiate and adhere to time-restricted eating. Adding a commitment device to bidirectional texting did not increase adherence to time-restricted eating compared with attention control, nor were there significant between group changes in blood pressure or weight, but these comparisons were underpowered. A larger randomized trial of the effect of this scalable intervention, compared with usual care, on blood pressure and weight among patients with obesity and hypertension is warranted. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov; unique identifier: NCT04836312.

Primary Care Appointment Completion Rates and Telemedicine Utilization Among Black and Non-Black Patients from 2019 to 2020.

Objective: To understand how differences in primary care appointment completion rates between Black and non-Black patients changed in 2020 within the context of the COVID-19 pandemic and when telemedicine utilization peaked. Materials and Methods: We conducted a retrospective cohort study using the electronic health record from January 1 to December 31, 2020, among all adults scheduled for a primary care appointment within a large academic medical center. We used mixed-effects logistic regression to estimate adjusted appointment completion rates for Black patients compared with those for non-Black patients in 2020 as compared with those in 2019 within four time periods: (1) prepandemic (January 1, 2020, to March 12, 2020), (2) shutdown (March 13, 2020, to June 3, 2020), (3) reopening (June 4, 2020, to September 30, 2020), and (4) second wave (October 1, 2020, to December 31, 2020). Results: Across 1,947,399 appointments, differences in appointment completion rates between Black and non-Black patients improved in all time periods: +1.4 percentage points prepandemic (95% confidence interval [CI]: +0.8 to +2.0), +11.7 percentage points during shutdown (95% CI: +11.0 to +12.3), +8.2 percentage points during reopening (95% CI: +7.8 to +8.7), and +7.1 percentage points during second wave (95% CI: +6.4 to +7.8) (all p-values <0.001). The types of conditions managed by primary care shifted during the shutdown period, but the remainder of 2020 mirrored those from 2019. Discussion: Racial differences in appointment completion rates narrowed significantly in 2020 even as the mix of disease conditions began to mirror patterns observed in 2019. Conclusions and Relevance: Telemedicine may be an important tool for improving access to primary care for Black patients. These findings should be key considerations as regulators and payors determine telemedicine's future.

Building a Heart Failure Clinic: A Practical Guide from the Heart Failure Society of America.

Heart failure (HF) remains a leading cause of mortality and morbidity and a primary driver of health care resource use in the United States. As such, there continues to be much interest in the development and refinement of HF clinics that manage patients with HF in a guideline-directed, technology-enabled, and coordinated approach. Optimization of resource use and maintenance of collaboration with other providers are also important themes when considering implementation of HF clinics. Through this document, the Heart Failure Society of America aims to provide a contemporary, practical guide to creating and sustaining a HF clinic. The guide discusses (1) patient care considerations for delivering guideline-directed and patient-centered care, and (2) operational considerations including development of a HF clinic business plan, setting goals, leadership support, triggers for patient referral and patient follow-up, patient population served, optimal clinic staffing models, relationships with subspecialists, and continuous quality improvement. This document was developed to empower providers and clinicians who wish to build and sustain community-based, successful HF clinics.

The Role of Behavioral Economics in Improving Cardiovascular Health Behaviors and Outcomes.

PURPOSE OF REVIEW: Behavioral economics represents a promising set of principles to inform the design of health-promoting interventions. Techniques from the field have the potential to increase quality of cardiovascular care given suboptimal rates of guideline-directed care delivery and patient adherence to optimal health behaviors across the spectrum of cardiovascular care delivery. RECENT FINDINGS: Cardiovascular health-promoting interventions have demonstrated success in using a wide array of principles from behavioral economics, including loss framing, social norms, and gamification. Such approaches are becoming increasingly sophisticated and focused on clinical cardiovascular outcomes in addition to health behaviors as a primary endpoint. Many approaches can be used to improve patient decisions remotely, which is particularly useful given the shift to virtual care in the context of the COVID-19 pandemic. Numerous applications for behavioral economics exist in the cardiovascular care delivery space, though more work is needed before we will have a full understanding of ways to best leverage such applications in each clinical context.

Evolution and Outcomes of Premature Coronary Artery Disease.

PURPOSE OF REVIEW: The purpose of this review is to explore the evolution and outcomes of premature coronary artery disease (PCAD) while reviewing strategies for effective screening of those at high risk for developing this disease. RECENT FINDINGS: Premature coronary artery disease (PCAD) affects a population of patients not typically identified as high risk by current risk stratification guidelines or traditional risk calculation tools. Not only does PCAD represent a large proportion of overall cardiovascular disease, it also afflicts a population in which the rate of mortality from cardiovascular disease has plateaued despite an overall declining population-wide cardiovascular mortality rate. There is ample opportunity for behavioral change strategies, screening tools, adapted imaging modalities, and precision pharmacotherapies to be more precisely targeted toward those at highest risk for premature coronary artery disease. Premature coronary artery disease (PCAD) is pervasive and not frequently represented within contemporary risk calculation models. Providers should pursue proactive screening and aggressive risk factor modification and deploy appropriate preventative therapies in caring for younger populations.

Outcomes of catheter-directed versus systemic thrombolysis for the treatment of pulmonary embolism: A real-world analysis of national administrative claims.

Catheter-directed thrombolysis (CDT) and systemic thrombolysis (ST) are used to treat intermediate/high-risk pulmonary embolism (PE) in the absence of comparative safety and effectiveness data. We utilized a large administrative database to perform a comparative safety and effectiveness analysis of catheter-directed versus systemic thrombolysis. From the Optum® Clinformatics® Data Mart private-payer insurance claims database, we identified 100,744 patients hospitalized with PE between 2004 and 2014. We extracted demographic characteristics, high-risk PE features, components of the Elixhauser Comorbidity Index, and outcomes including intracranial hemorrhage (ICH), all-cause bleeding, and mortality among all patients receiving CDT and ST. We used propensity score methods to compare outcomes between matched cohorts adjusted for observed confounders. A total of 1915 patients (1.9%) received either CDT (n = 632) or ST (n = 1283). Patients in the CDT group had fewer high-risk features including less shock (5.4 vs 11.1%; p < 0.001) and cardiac arrest (6.8 vs 11.0%; p = 0.004). In 1:1 propensity-matched groups, ICH rates were 1.9% in both the CDT and ST groups (p = 1.0). All-cause bleeding was higher in the CDT group (15.9 vs 8.7%; p < 0.001), while in-hospital mortality was lower (6.5 vs 10.0%; p = 0.02). Among a nationally representative cohort of patients with PE at higher risk for mortality, CDT was associated with similar ICH rates, increased all-cause bleeding, and lower short and intermediate-term mortality when compared with ST. The competing risks and benefits of CDT in real-world practice suggest the need for large-scale randomized clinical trials with appropriate comparator arms.

Pulmonary Hypertension Due to Left Ventricular Cardiomyopathy: Is it the Result or Cause of Disease Progression?

PURPOSE OF REVIEW: The purpose of this review is to define pulmonary hypertension in the setting of left heart disease (PH-LHD), discuss its epidemiology and pathophysiology, and highlight the cause and effect relationship it has with disease progression in the setting of cardiomyopathy. RECENT FINDINGS: Both pulmonary hypertension (PH) and heart failure are becoming increasingly common. As such, PH-LHD is now the most common form of PH. The pathophysiology of the condition relates to backward transmission of elevated left ventricular filling pressures into the pulmonary circulation and, ultimately, right ventricular (RV) strain/dysfunction. It is evident that these pathophysiologic processes are both the effect and cause of left heart disease progression. In this review, we describe the complex relationship between disease progression in left ventricular cardiomyopathy and PH-LHD. Clinicians and researchers should take note of the importance of PH-LHD and RV dysfunction to appropriately risk stratify patients and develop therapies for the condition.

Cardiotoxicity from bruton tyrosine kinase inhibitors (BTKi)-an analysis of an administrative health claims database.

BACKGROUND: First generation Bruton tyrosine kinase inhibitors (BTKi) such as ibrutinib have been associated with cardiovascular toxicities. Newer generation BTKi (e.g.,acalabrutinib and zanabrutinib) have been associated with lower incidence of cardiotoxicity in clinical trials. OBJECTIVE: Given paucity in real-world data on the overall cardiac risk factor profile, especially with the newer BTKi, our study evaluated the incidence of cardiotoxicity with various BTKi among a large, commercially insured population of patients. METHODS: We performed a retrospective cohort analysis of all adults with a diagnosis of B-cell malignancy undergoing treatment with BTKi acalabrutinib and ibrutinib between January 2018 and June 2020 using Optum's de-identified Clinformatics® Data Mart Database. We then identified patients who had pre-existing cardiac disease one year prior to starting BTKi. New incidence of atrial fibrillation/flutter, hypertension, bleeding, ventricular tachycardia/fibrillation and sudden cardiac death from the time of index presciption were compared with standard Chi Square or Student t-test where appropriate. Multivariate logistic regression models were also estimated to evaluate for confounding. RESULTS: A total of 1691 patients were included in the final analysis. 1595 (94%, median age 75 (19-90) years, 61% male gender) patients received ibrutinib, and 96 (6%, median age 73.5 (32-90) years, 62.5% male gender) patients received acalabrutinib. The median duration of drug exposure of ibrutinib was 238 (2-1084) days vs. 150 (30-870) days for acalabrutinib. There was lower new incidence of atrial fibrillation/flutter (4.6%-vs-17%, p = 0.013), hypertension (6.3%-vs-25%, p = NS), sudden cardiac arrest/death (0% vs. 1.5%, p = NS) in the acalabrutinib group compared to ibrutinib, of which only the lower incidence of atrial fibrillation/flutter was statistically significant. This was despite the finding of a higher prevalence of atrial fibrillation/flutter at baseline in patients receiving acalabrutinib. CONCLUSIONS: There was lower incidence of new atrial fibrillation/flutter with acalabrutinib when compared to ibrutinib in a real-world cohort of patients.

Assessing Heuristic Bias During Care for Patients Hospitalized for Heart Failure: Get With The Guidelines-Heart Failure.

BACKGROUND: Heuristic biases are increasingly recognized, and potentially modifiable, contributors to patient care and outcomes. Left digit bias is a cognitive bias where continuous variables are categorized by their left-most digit. The impact of this heuristic bias applied to patient age on quality of care in heart failure has not been explored. METHODS: We examined participants admitted from 2005 to 2021 in the Get With The Guidelines-Heart Failure registry. To create 2 naturally randomized groups, isolating the effect of left digit bias, we dichotomized patients into those discharged within 60 days prior to their 80th birthday (N=4238) and those discharged within 60 days after their 80th birthday (N=4329). We performed multivariable logistic regression to assess the association between discharge date relative to 80th birthday and several in-hospital quality metrics and in-hospital outcomes. Among Medicare participants (N=2759), we performed adjusted Cox regression to analyze the relationship between discharge date and risk of 1-year mortality or readmission. RESULTS: Among 8567 patients, 50.4% were female, 73% were non-Hispanic White, and 42.9% had an ejection fraction ≤40%. Discharge date relative to 80th birthday was not associated with numerous in-hospital quality metrics or in-hospital outcomes on unadjusted or adjusted logistic regression. Among Medicare beneficiaries, there was no association between discharge date and risk of mortality or readmission at 1-year postdischarge (hazard ratio, 1.03 [95% CI, 0.95-1.12]; P=0.52). CONCLUSIONS: In a large registry of patients hospitalized for heart failure, we did not detect a left digit bias' with respect to age at discharge, which resulted in differential quality of care or outcomes.

Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial.

Importance: Statins reduce the risk of major adverse cardiovascular events, but less than one-half of individuals in America who meet guideline criteria for a statin are actively prescribed this medication. Objective: To evaluate whether nudges to clinicians, patients, or both increase initiation of statin prescribing during primary care visits. Design, Setting, and Participants: This cluster randomized clinical trial evaluated statin prescribing of 158 clinicians from 28 primary care practices including 4131 patients. The design included a 12-month preintervention period and a 6-month intervention period between October 19, 2019, and April 18, 2021. Interventions: The usual care group received no interventions. The clinician nudge combined an active choice prompt in the electronic health record during the patient visit and monthly feedback on prescribing patterns compared with peers. The patient nudge was an interactive text message delivered 4 days before the visit. The combined nudge included the clinician and patient nudges. Main Outcomes and Measures: The primary outcome was initiation of a statin prescription during the visit. Results: The sample comprised 4131 patients with a mean (SD) age of 65.5 (10.5) years; 2120 (51.3%) were male; 1210 (29.3%) were Black, 106 (2.6%) were Hispanic, 2732 (66.1%) were White, and 83 (2.0%) were of other race or ethnicity, and 933 (22.6%) had atherosclerotic cardiovascular disease. In unadjusted analyses during the preintervention period, statins were prescribed to 5.6% of patients (105 of 1876) in the usual care group, 4.8% (97 of 2022) in the patient nudge group, 6.0% (104 of 1723) in the clinician nudge group, and 4.7% (82 of 1752) in the combined group. During the intervention, statins were prescribed to 7.3% of patients (75 of 1032) in the usual care group, 8.5% (100 of 1181) in the patient nudge group, 13.0% (128 of 981) in the clinician nudge arm, and 15.5% (145 of 937) in the combined group. In the main adjusted analyses relative to usual care, the clinician nudge significantly increased statin prescribing alone (5.5 percentage points; 95% CI, 3.4 to 7.8 percentage points; P = .01) and when combined with the patient nudge (7.2 percentage points; 95% CI, 5.1 to 9.1 percentage points; P = .001). The patient nudge alone did not change statin prescribing relative to usual care (0.9 percentage points; 95% CI, -0.8 to 2.5 percentage points; P = .32). Conclusions and Relevance: Nudges to clinicians with and without a patient nudge significantly increased initiation of a statin prescription during primary care visits. The patient nudge alone was not effective. Trial Registration: ClinicalTrials.gov Identifier: NCT04307472.

Training digital natives to transform healthcare: a 5-tiered approach for integrating clinical informatics into undergraduate medical education.

Expansive growth in the use of health information technology (HIT) has dramatically altered medicine without translating to fully realized improvements in healthcare delivery. Bridging this divide will require healthcare professionals with all levels of expertise in clinical informatics. However, due to scarce opportunities for exposure and training in informatics, medical students remain an underdeveloped source of potential informaticists. To address this gap, our institution developed and implemented a 5-tiered clinical informatics curriculum at the undergraduate medical education level: (1) a practical orientation to HIT for rising clerkship students; (2) an elective for junior students; (3) an elective for senior students; (4) a longitudinal area of concentration; and (5) a yearlong predoctoral fellowship in operational informatics at the health system level. Most students found these offerings valuable for their training and professional development. We share lessons and recommendations for medical schools and health systems looking to implement similar opportunities.

Predictors of telemedicine use during the COVID-19 pandemic in the United States-an analysis of a national electronic medical record database.

Telemedicine utilization increased significantly in the United States during the COVID-19 pandemic. However, there is concern that disadvantaged groups face barriers to access based on single-center studies. Whether there has been equitable access to telemedicine services across the US and during later parts of the pandemic is unclear. This study retrospectively analyzes outpatient medical encounters for patients 18 years of age and older using Healthjump-a national electronic medical record database-from March 1 to December 31, 2020. A mixed effects multivariable logistic regression model was used to assess the association between telemedicine utilization and patient and area-level factors and the odds of having at least one telemedicine encounter during the study period. Among 1,999,534 unique patients 21.6% had a telemedicine encounter during the study period. In the multivariable model, age [OR = 0.995 (95% CI 0.993, 0.997); p<0.001], non-Hispanic Black race [OR = 0.88 (95% CI 0.84, 0.93); p<0.001], and English as primary language [OR = 0.78 (95% CI 0.74, 0.83); p<0.001] were associated with a lower odds of telemedicine utilization. Female gender [OR = 1.24 (95% CI 1.22, 1.27); p<0.001], Hispanic ethnicity or non-Hispanic other race [OR = 1.40 (95% CI 1.33, 1.46);p<0.001 and 1.29 (95% CI 1.20, 1.38); p<0.001, respectively] were associated with a higher odds of telemedicine utilization. During the COVID-19 pandemic, therefore, utilization of telemedicine differed significantly among patient groups, with older and non-Hispanic Black patients less likely to have telemedicine encounters. These findings are relevant for ongoing efforts regarding the nature of telemedicine as the COVID-19 pandemic ends.

Novel Digital Technologies for Blood Pressure Monitoring and Hypertension Management.

PURPOSE OF REVIEW: Hypertension is common, impacting an estimated 108 million US adults, and deadly, responsible for the deaths of one in six adults annually. Optimal management includes frequent blood pressure monitoring and antihypertensive medication titration, but in the traditional office-based care delivery model, patients have their blood pressure measured only intermittently and in a way that is subject to misdiagnosis with white coat or masked hypertension. There is a growing opportunity to leverage our expanding repository of digital technology to reimagine hypertension care delivery. This paper reviews existing and emerging digital tools available for hypertension management, as well as behavioral economic insights that could supercharge their impact. RECENT FINDINGS: Digitally connected blood pressure monitors offer an alternative to office-based blood pressure monitoring. A number of cuffless blood pressure monitors are in development but require further validation before they can be deployed for widespread clinical use. Patient-facing hubs and applications offer a means to transmit blood pressure data to clinicians. Though artificial intelligence could allow for curation of this data, its clinical use for hypertension remains limited to assessing risk factors at this time. Finally, text-based and telemedicine platforms are increasingly being employed to translate hypertension data into clinical outcomes with promising results. SUMMARY: The digital management of hypertension shows potential as an avenue for increasing patient engagement and improving clinical efficiency and outcomes. It is important for clinicians to understand the benefits, limitations, and future directions of digital health to optimize management of hypertension.

Focused Cardiac Ultrasound Curriculum for Internal Medicine Residents.

Background: Focused cardiac ultrasound (FCU) is a safe and efficient diagnostic intervention for internal medicine physicians. FCU is a highly teachable skill, but is used in routine cardiac assessment in only 20% of surveyed training programs.We developed an FCU curriculum for internal medicine residents and an assessment tool to evaluate the impact of the curriculum on trainee knowledge and confidence. Methods: Internal medicine residents rotating through clinical cardiology services underwent 30 minutes of didactic and 60 minutes of hands-on teaching on acquisition and interpretation of FCU. A 20 item pre and post-curriculum online survey was administered (November 2018-December 2019) to assess confidence and knowledge in FCU. Results: 79 of 116 (68%) residents completed the pre-survey and 50 completed the post-survey, of whom 34 received the curriculum. The mean change in confidence score in those who received versus did not receive the curriculum was 0.99 versus 0.39 (p=0.046) on a 5-point Likert scale. Among 33 residents who had paired pre- and post-surveys the mean change in confidence score was 1.2 versus 0.85 (p<0.001) in those who received versus did not receive the curriculum. The mean increase in knowledge score was 13% versus 7% respectively (p<0.0001). Conclusions: We instituted a novel curriculum for internal medicine residents to gain experience in image acquisition and interpretation. Both confidence and knowledge in FCU improved following the curriculum, indicating that this is a highly teachable skill. Additional analysis of the of the FCU study images will be useful for informing future interventions.