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.

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.

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.

A Mobile, Electronic Health Record-Connected Application for Managing Team Workflows in Inpatient Care.

BACKGROUND: Clinical workflows require the ability to synthesize and act on existing and emerging patient information. While offering multiple benefits, in many circumstances electronic health records (EHRs) do not adequately support these needs. OBJECTIVES: We sought to design, build, and implement an EHR-connected rounding and handoff tool with real-time data that supports care plan organization and team-based care. This article first describes our process, from ideation and development through implementation; and second, the research findings of objective use, efficacy, and efficiency, along with qualitative assessments of user experience. METHODS: Guided by user-centered design and Agile development methodologies, our interdisciplinary team designed and built Carelign as a responsive web application, accessible from any mobile or desktop device, that gathers and integrates data from a health care institution's information systems. Implementation and iterative improvements spanned January to July 2016. We assessed acceptance via usage metrics, user observations, time-motion studies, and user surveys. RESULTS: By July 2016, Carelign was implemented on 152 of 169 total inpatient services across three hospitals staffing 1,616 hospital beds. Acceptance was near-immediate: in July 2016, 3,275 average unique weekly users generated 26,981 average weekly access sessions; these metrics remained steady over the following 4 years. In 2016 and 2018 surveys, users positively rated Carelign's workflow integration, support of clinical activities, and overall impact on work life. CONCLUSION: User-focused design, multidisciplinary development teams, and rapid iteration enabled creation, adoption, and sustained use of a patient-centered digital workflow tool that supports diverse users' and teams' evolving care plan organization needs.

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.

Plasma biomarkers associated with adverse outcomes in patients with calcific aortic stenosis.

AIMS: Enhanced risk stratification of patients with aortic stenosis (AS) is necessary to identify patients at high risk for adverse outcomes, and may allow for better management of patient subgroups at high risk of myocardial damage. The objective of this study was to identify plasma biomarkers and multimarker profiles associated with adverse outcomes in AS. METHODS AND RESULTS: We studied 708 patients with calcific AS and measured 49 biomarkers using a Luminex platform. We studied the correlation between biomarkers and the risk of (i) death and (ii) death or heart failure-related hospital admission (DHFA). We also utilized machine-learning methods (a tree-based pipeline optimizer platform) to develop multimarker models associated with the risk of death and DHFA. In this cohort with a median follow-up of 2.8 years, multiple biomarkers were significantly predictive of death in analyses adjusted for clinical confounders, including tumour necrosis factor (TNF)-α [hazard ratio (HR) 1.28, P < 0.0001], TNF receptor 1 (TNFRSF1A; HR 1.38, P < 0.0001), fibroblast growth factor (FGF)-23 (HR 1.22, P < 0.0001), N-terminal pro B-type natriuretic peptide (NT-proBNP) (HR 1.58, P < 0.0001), matrix metalloproteinase-7 (HR 1.24, P = 0.0002), syndecan-1 (HR 1.27, P = 0.0002), suppression of tumorigenicity-2 (ST2) (IL1RL1; HR 1.22, P = 0.0002), interleukin (IL)-8 (CXCL8; HR 1.22, P = 0.0005), pentraxin (PTX)-3 (HR 1.17, P = 0.001), neutrophil gelatinase-associated lipocalin (LCN2; HR 1.18, P < 0.0001), osteoprotegerin (OPG) (TNFRSF11B; HR 1.26, P = 0.0002), and endostatin (COL18A1; HR 1.28, P = 0.0012). Several biomarkers were also significantly predictive of DHFA in adjusted analyses including FGF-23 (HR 1.36, P < 0.0001), TNF-α (HR 1.26, P < 0.0001), TNFR1 (HR 1.34, P < 0.0001), angiopoietin-2 (HR 1.26, P < 0.0001), syndecan-1 (HR 1.23, P = 0.0006), ST2 (HR 1.27, P < 0.0001), IL-8 (HR 1.18, P = 0.0009), PTX-3 (HR 1.18, P = 0.0002), OPG (HR 1.20, P = 0.0013), and NT-proBNP (HR 1.63, P < 0.0001). Machine-learning multimarker models were strongly associated with adverse outcomes (mean 1-year probability of death of 0%, 2%, and 60%; mean 1-year probability of DHFA of 0%, 4%, 97%; P < 0.0001). In these models, IL-6 (a biomarker of inflammation) and FGF-23 (a biomarker of calcification) emerged as the biomarkers of highest importance. CONCLUSIONS: Plasma biomarkers are strongly associated with the risk of adverse outcomes in patients with AS. Biomarkers of inflammation and calcification were most strongly related to prognosis.

Insourcing and scaling a telemedicine solution in under 2 weeks: Lessons for the digital transformation of health care.

The Covid-19 pandemic required rapid scale of telemedicine as well as other digital workflows to maintain access to care while reducing infection risk. Both patients and clinicians who hadn't used telemedicine before were suddenly faced with a multi-step setup process to log into a virtual meeting. Unlike in-person examination rooms, locking a virtual meeting room was more error-prone and posed a risk of multiple patients joining the same online session. There was administrative burden on the practice staff who were generating and manually sending links to patients, and educating patients on device set up was time-consuming and unsustainable. A solution had to be deployed rapidly system-wide, without the usual roll out across months. Our answer was to design and implement a novel EHR-integrated web application called the Switchboard, in just two weeks. The Switchboard leverages a commercial, cloud-based video meeting platform and facilitates an end-to-end virtual care encounter workflow, from pre-visit reminders to post-visit SMS text message-based measurement of patient experience, with tools to extend contact-less workflows to in-person appointments. Over the first 11 months of the pandemic, the in-house platform has been adopted across 6 hospitals and >200 practices, scaled to 8,800 clinicians who at their peak conducted an average of 30,000 telemedicine appointments/week, and enabled over 10,000-20,000 text messages/day to be exchanged through the platform. Furthermore, it enabled our organization to convert from an average of 75% of telehealth visits being conducted via telephone to 75% conducted via video within weeks.

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.