Measuring the Influence of Side Effect Expectations, Beliefs, and Incident Side Effects on the Risk for Drug Discontinuation Among Individuals Starting New Medications, a Cross-sectional Study.

Purpose: To measure the impact of beliefs, expectations, side effects, and their combined effects on the risk for medication nonpersistence. Patients and methods: Using a cross-sectional design, individuals from Saskatchewan, Canada who started a new antihypertensive, cholesterol-lowering, or antihyperglycemic medication were surveyed about risk factors for nonpersistence including: (a) beliefs measured by a composite score of three questions asking about the threat of the condition, importance of the drug, and harm of the drug; (b) incident side effects attributed to treatment; and (c) expectations for side effects before starting treatment. Descriptive statistics and logistic regression models were used to quantify the influence of these risk factors on the outcome of nonpersistence. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results: Among 3,029 respondents, 5.8% (n=177) reported nonpersistence within four months after starting the new drug. After adjustment for numerous covariates representing sociodemographics, health-care providers, medication experiences and beliefs, both negative beliefs (OR: 7.26, 95%CI: 4.98-10.59) and incident side effects (OR: 8.00, 95%CI: 5.49-11.68) were associated with the highest odds of nonpersistence with no evidence of interaction. In contrast, expectations for side effects before starting treatment exhibited an important interaction with incident side effects following treatment initiation. Among respondents with incident side effects (n=741, 24.5%), the risk for early nonpersistence was 11.5% if they indicated an expectation for side effects before starting the medication compared to 23.6% if they did not (adjusted OR: 0.38, 95%CI: 0.25-0.60). Conclusion: Expectations for side effects may be a previously unrecognized but important marker of the probability to persist with treatment. A high percentage of new medication users appeared unprepared for the possibility of side effects from their new medication making them less resilient if side effects occur.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Pragmatic trial evaluating the impact of simulation training on high-risk prescribing to older adults by junior physicians.

BACKGROUND: High-risk medications like benzodiazepines, sedative hypnotics, and antipsychotics are commonly prescribed for hospitalized older adults, despite guidelines recommending avoidance. Prior interventions have not fully addressed how physicians make such prescribing decisions, particularly when experiencing stress or cognitive overload. Simulation training may help improve prescribing decision-making but has not been evaluated for overprescribing. METHODS: In this two-arm pragmatic trial, we randomized 40 first-year medical resident physicians (i.e., interns) on inpatient general medicine services at an academic medical center to either intervention (a 40-minute immersive simulation training) or control (online educational training) groups. The primary outcome was the number of new benzodiazepine, sedative hypnotic, or antipsychotic orders for treatment-naïve older adults during hospitalization. Secondary outcomes included the same outcome by all providers, being discharged on one of the medications, and orders for related or control medications. Outcomes were measured using electronic health record data over each intern's service period (~2 weeks). Outcomes were evaluated using generalized estimating equations, adjusting for clustering. RESULTS: In total, 522 treatment-naïve older adult patients were included in analyses. Over follow-up, interns prescribed ≥1 high-risk medication for 13 (4.9%) intervention patients and 13 (5.0%) control patients. The intervention led to no difference in the number of new prescriptions (Rate Ratio [RR]: 0.85, 95%CI: 0.31-2.35) versus control and no difference in secondary outcomes. In secondary analyses, intervention interns wrote significantly fewer "as-needed" ("PRN") order types for the high-risk medications (RR: 0.29, 95%CI: 0.08-0.99), and instead tended to write more "one-time" orders than control interns, though this difference was not statistically significant (RR: 2.20, 95%CI: 0.60-7.99). CONCLUSIONS: Although this simulation intervention did not impact total high-risk prescribing for hospitalized older adults, it did influence how the interns prescribed, resulting in fewer PRN orders, suggesting possibly greater ownership of care. Future interventions should consider this insight and implementation lessons raised. TRIAL REGISTRATION: Clinicaltrials.gov(NCT04668248).

The impact of using reinforcement learning to personalize communication on medication adherence: findings from the REINFORCE trial.

Text messaging can promote healthy behaviors, like adherence to medication, yet its effectiveness remains modest, in part because message content is rarely personalized. Reinforcement learning has been used in consumer technology to personalize content but with limited application in healthcare. We tested a reinforcement learning program that identifies individual responsiveness ("adherence") to text message content and personalizes messaging accordingly. We randomized 60 individuals with diabetes and glycated hemoglobin A1c [HbA1c] ≥ 7.5% to reinforcement learning intervention or control (no messages). Both arms received electronic pill bottles to measure adherence. The intervention improved absolute adjusted adherence by 13.6% (95%CI: 1.7%-27.1%) versus control and was more effective in patients with HbA1c 7.5- < 9.0% (36.6%, 95%CI: 25.1%-48.2%, interaction p < 0.001). We also explored whether individual patient characteristics were associated with differential response to tested behavioral factors and unique clusters of responsiveness. Reinforcement learning may be a promising approach to improve adherence and personalize communication at scale.

Disentangling drug contributions: anticholinergic burden in older adults linked to individual medications: a cross-sectional population-based study.

BACKGROUND: Medications with potent anticholinergic properties have well-documented adverse effects. A high cumulative anticholinergic burden may arise from the concurrent use of multiple medications with weaker anticholinergic effects. We sought to identify patterns of high anticholinergic burden and associated patient characteristics. METHODS: We identified patients aged ≥ 65 who filled ≥ 1 medication with anticholinergic adverse effects in 2019 and had a cumulative Anticholinergic Burden score (ACB) ≥ 4 (i.e., high anticholinergic burden) in a large US health insurer. We classified patients based on how they attained high burden, as follows: 1) only filling strong or moderate anticholinergic medications (i.e., ACB = 2 or 3, "moderate/strong"), 2) only filling lightly anticholinergic medications (i.e., ACB = 1, "light/possible"), and 3) filling any combination ("mix"). We used multinomial logistic regression to assess the association between measured patient characteristics and membership in the three anticholinergic burden classifications, using the moderate/strong group as the referent. RESULTS: In total, 83,286 eligible patients with high anticholinergic burden were identified (mean age: 74.3 years (SD:7.1), 72.9% female). Of these, 4.5% filled only strong/moderate anticholinergics, 4.3% filled only light/possible anticholinergics, and the rest filled a mix (91.2%). Within patients in the mixed group, 64.3% of medication fills were for light/possible anticholinergics, while 35.7% were for moderate/strong anticholinergics. Compared with patients in the moderate/strong anticholinergics group, patients filling only light/possible anticholinergics were more likely to be older (adjusted Odds Ratio [aOR] per 1-unit of age: 1.06, 95%CI: 1.05-1.07), less likely to be female (aOR: 0.56, 95%CI: 0.50-0.62 vs. male), more likely to have comorbidities (e.g., heart failure aOR: 3.18, 95%CI: 2.70-3.74 or depression aOR: 1.20, 95%CI: 1.09-1.33 vs. no comorbidity), and visited fewer physicians (aOR per 1-unit of change: 0.98, 95%CI: 0.97-0.98). Patients in the mixed group were older (aOR per 1-unit of age: 1.02, 95%CI: 1.02-1.03) and less likely to be female (aOR: 0.89, 95%CI: 0.82-0.97 vs. male) compared with those filling moderate/strong anticholinergics. CONCLUSION: Most older adults accumulated high anticholinergic burden through a combination of light/possible and moderate/strong anticholinergics rather than moderate/strong anticholinergics, with light/possible anticholinergics being the major drivers of overall anticholinergic burden. These insights may inform interventions to improve prescribing in older adults.

Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial.

BACKGROUND: Clinical inertia, or failure to intensify treatment when indicated, leads to suboptimal blood pressure control. Interventions to overcome inertia and increase antihypertensive prescribing have been modestly successful in part because their effectiveness varies based on characteristics of the provider, the patient, or the provider-patient interaction. Understanding for whom each intervention is most effective could help target interventions and thus increase their impact. METHODS: This three-arm, randomized trial tests the effectiveness of 2 interventions to reduce clinical inertia in hypertension prescribing compared to usual care. Forty five primary care providers (PCPs) caring for patients with hypertension in need of treatment intensification completed baseline surveys that assessed behavioral traits and were randomized to one of three arms: 1) Pharmacist e-consult, in which a clinical pharmacist provided patient-specific recommendations for hypertension medication management to PCPs in advance of upcoming visits, 2) Social norming dashboards that displayed PCP's hypertension control rates compared to those of their peers, or 3) Usual care (no intervention). The primary outcome was the rate of intensification of hypertension treatment. We will compare this outcome between study arms and then evaluate the association between characteristics of providers, patients, their clinical interactions, and intervention responsiveness. RESULTS: Forty-five primary care providers were enrolled and randomized: 16 providers and 173 patients in the social norming dashboards arm, 15 providers and 143 patients in the pharmacist e-consult arm, and 14 providers and 150 patients in the usual care arm. On average, the mean patient age was 64 years, 47% were female, and 73% were white. Baseline demographic and clinical characteristics of patients were similar across arms, with the exception of more Hispanic patients in the usual care arm and fewest in the pharmacist e-consult arm. CONCLUSIONS: This study can help identify interventions to reduce inertia in hypertension care and potentially identify the characteristics of patients, providers, or patient-provider interactions to understand for whom each intervention would be most beneficial. TRIAL REGISTRATION: Clinicaltrials.gov (NCT, Registered: NCT04603560).

"How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial.

BACKGROUND: Messages aimed at increasing uptake of vaccines have been modestly successful, perhaps in part because they often focus on why individuals should receive a vaccine. Construal Level Theory posits that messages emphasizing "how" to get a vaccine may be more effective at encouraging vaccination than emphasizing "why." This message framing may be particularly important for COVID-19 booster acceptance. OBJECTIVE: To determine if pre-visit patient portal messages designed using Construal Level Theory increase rates of COVID-19 booster vaccination. DESIGN AND INTERVENTIONS: This 3-arm randomized trial was conducted across three large, diverse primary care clinics in Massachusetts between February and May 2022, testing the impact of "how" versus "why" framed pre-visit messages versus no messages ("usual care"). Messages were sent by patient portal two business days before a visit. PARTICIPANTS: Adults with upcoming primary care visits who had electronic health record evidence of receiving their initial COVID-19 vaccination series but not a booster dose. MAIN MEASURES: Receipt of a COVID-19 booster vaccination after the message was sent through the visit date (primary outcome) or 6 weeks (secondary outcome). KEY RESULTS: A total of 3665 patients were randomized (mean age: 53.5 years (SD: 17.3), 59% female, 65.2% White, 26.6% Hispanic), with 1249 to "how" 1199 to "why," and 1217 to usual care arms. Except for clinic and preferred language, characteristics were well balanced across arms. Rates of COVID-19 booster were 13.6% (usual care), 11.7% ("how") (odds ratio (OR) "how" vs usual care: 0.87, 95%CI: 0.67-1.14), and 13.7% ("why") ("why" vs usual care: OR: 1.01, 95%CI: 0.81-1.28). At 6 weeks, "why" outperformed "how" for vaccination (OR: 1.26, 95%CI: 1.06-1.49), with no difference versus usual care. CONCLUSIONS: We found no differences on visit booster receipt after single pre-visit portal messages designed using Construal Level Theory. Further studies to identify effective messaging interventions are needed, especially as additional doses are recommended. CLINICAL TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov, ID: NCT04871776 . Initial release occurred 04/30/2021.

Investigating the ability to adhere to cardiometabolic medications with different properties: a retrospective cohort study of >500 000 patients in the USA.

OBJECTIVE: Poor medication adherence remains highly prevalent and adversely affects health outcomes. Patients frequently describe properties of the pills themselves, like size and shape, as barriers, but this has not been evaluated objectively. We sought to determine the extent to which oral medication properties thought to be influential translate into lower objectively-measured adherence. DESIGN: Retrospective cohort study. SETTING: US nationwide commercial claims database, 2016-2019. PARTICIPANTS: Among patients initiating first-line hypertension, diabetes or hyperlipidaemia treatment based on clinical guidelines, we measured pill size, shape, colour and flavouring, number of pills/day and fixed-dose combination status as properties. OUTCOME MEASURES: Outcomes included discontinuation after the first fill (ie, never filling again over a minimum of 1-year follow-up) and long-term non-adherence (1-year proportion of days covered <0.80). We estimated associations between each property and outcomes, by therapeutic class (eg, statins), with multivariable logistic regression. RESULTS: Across 604 323 patients, 14.6% discontinued after filling once (ie, were non-persistent), and 54.0% were non-adherent over 1-year follow-up. Large pill size was associated with non-adherence, except for thiazides (eg, metformin adjusted OR (aOR): 1.12, 95% CI: 1.06 to 1.18). Greater pill burden was associated with a higher risk of non-adherence across all classes (eg, metformin aOR: 1.58, 95% CI: 1.53 to 1.64 for two pills/day). Taking less than one pill/day was also associated with higher risk of non-adherence and non-persistence (eg, non-persistence statin aOR: 1.29, 95% CI: 1.20 to 1.38). Pill shape, colour, flavouring and combination status were associated with mixed effects across classes. CONCLUSIONS: Pill burden and pill size are key properties affecting adherence for almost all classes; others, like size and combination, could modestly affect medication adherence. Clinical interventions could screen patients for potential intolerance to medication and potentially implement more convenient dosing schedules.

Costs of Prescription Drugs for Children and Parental Adherence to Long-Term Medications.

Importance: The adverse effects of prescription drug costs on medication adherence and health have been well described for individuals. Because many families share financial resources, high medication costs for one could lead to cost-related nonadherence in another; however, these family-level spillover effects have not been explored. Objective: To evaluate whether the cost of a child's newly initiated medication was associated with changes in their parent's adherence to their own medications and whether that differed by likely duration of treatment. Design, Setting, and Participants: This cohort study used interrupted time-series analysis with a propensity score-matched control group from a large national US health insurer database (2010-2020) and included children initiating medication and their linked presumed parents using long-term medications. Exposure: The cost of the child's initiated medication. Child medication cost was classified based on highest (≥90th) or lowest (<10th) decile from out-of-pocket medication spending, stratified by whether the medication was intended for short- or long-term use. Children initiating high-cost medications (based on the highest decile) were propensity-score matched with children initiating low-cost medications. Main Outcome and Measures: The child's parent's adherence to long-term medication assessed by the widely used proportion of days covered metric in 30-day increments before and after the child's first fill date. Parent demographic characteristics, baseline adherence, and length of treatment, and family unit size and out-of-pocket medication spending were key subgroups. Results: Across 47 154 included pairs, the parents' mean (SD) age was 42.8 (7.7) years. Compared with a low-cost medication, initiating a high-cost, long-term medication was associated with an immediate 1.9% (95% CI, -3.8% to -0.9%) reduction in parental adherence sustained over time (0.2%; 95% CI, -0.1% to 0.4%). Similar results were observed for short-term medications (0.6% immediate change; 95% CI, -1.3% to -0.01%). Previously adherent parents, parents using treatment for longer periods, and families who spent more out-of-pocket on medications were more sensitive to high costs, with immediate adherence reductions of 2.8% (95% CI, -4.9% to -0.6%), 2.7% (95% CI, -4.7% to -0.7%), and -3.8% (95% CI, -7.2% to -0.5%), respectively, after long-term medication initiation. Conclusions and Relevance: In this cohort study small reductions in adherence across parents with higher child drug costs were observed. Health care systems should consider child-level or even household-level spending in adherence interventions or prescription policy design.

Treatment Patterns for Alopecia Areata in the US.

Importance: Alopecia areata (AA) is characterized by hair loss ranging from patches of hair loss to more extensive forms, including alopecia totalis (AT) and alopecia universalis (AU). There is a lack of consensus for treatment. Understanding current practice patterns could help the identification of treatment needs and development of standards of care. Objective: To review treatment patterns for adults with AA in the US between 2015 and 2020. Design, Setting, and Participants: This retrospective cohort study used medicine and pharmacy claims for commercially insured individuals from the IBM MarketScan Research Database to assess adults (≥18 years) newly treated for AA between October 15, 2015, and February 28, 2020. Alopecia areata was identified based on having at least 1 diagnosis of International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code L63.x. Patients were required to have at least 365 days of continuous health plan enrollment before and after the cohort entry date. Patients were required to be free of AA diagnosis codes 365 days before the cohort entry date. Statistical analyses were conducted between 2019 and 2023. Main Outcomes and Measures: Main outcomes were treatment patterns for all patients with AA and subgroups of (1) patients with AT or AU and (2) those cared for by a dermatologist on the cohort entry date. Longitudinal therapy course during the first year after the diagnosis was also examined. Results: The study cohort consisted of 45 483 individuals (mean [SD] age, 43.8 [14.2] years; 29 903 [65.7%] female). During the year of follow-up, 30 217 patients (66.4%) received at least 1 AA treatment. The most common treatments were intralesional (19 014 [41.8%]), topical (18 604 [40.9%]), intramuscular (17 328 [38.1%]), and oral (9378 [20.6%]) corticosteroids. Compared with patients without AT or AU, patients with AT or AU a lower frequency of intralesional steroid (359 [11.1%] vs 18 655 [44.1%], P < .001) and higher frequency of topical corticosteroid (817 [25.4%] vs 17 787 [42.1%], P < .001) use. Almost half of patients (21 489 [47.2%]) received no treatment on the day of diagnosis. By 12 months, 32 659 (71.8%) were not receiving any treatment, making no treatment the largest study group. Conclusions and Relevance: In this large cohort study of commercially insured individuals, corticosteroids were the most commonly used treatment for adults with AA between 2015 and 2020. At 365 days after diagnosis, more than two-thirds of patients were no longer receiving any AA treatment. Further studies are needed to understand the reasons for the absence of treatment.

A pragmatic clinical trial assessing the effect of a targeted notification and clinical support pathway on the diagnostic evaluation and treatment of individuals with left ventricular hypertrophy (NOTIFY-LVH).

BACKGROUND: Electronic health records contain vast amounts of cardiovascular data, including potential clues suggesting unrecognized conditions. One important example is the identification of left ventricular hypertrophy (LVH) on echocardiography. If the underlying causes are untreated, individuals are at increased risk of developing clinically significant pathology. As the most common cause of LVH, hypertension accounts for more cardiovascular deaths than any other modifiable risk factor. Contemporary healthcare systems have suboptimal mechanisms for detecting and effectively implementing hypertension treatment before downstream consequences develop. Thus, there is an urgent need to validate alternative intervention strategies for individuals with preexisting-but potentially unrecognized-LVH. METHODS: Through a randomized pragmatic trial within a large integrated healthcare system, we will study the impact of a centralized clinical support pathway on the diagnosis and treatment of hypertension and other LVH-associated diseases in individuals with echocardiographic evidence of concentric LVH. Approximately 600 individuals who are not treated for hypertension and who do not have a known cardiomyopathy will be randomized. The intervention will be directed by population health coordinators who will notify longitudinal clinicians and offer to assist with the diagnostic evaluation of LVH. Our hypothesis is that an intervention that alerts clinicians to the presence of LVH will increase the detection and treatment of hypertension and the diagnosis of alternative causes of thickened myocardium. The primary outcome is the initiation of an antihypertensive medication. Secondary outcomes include new hypertension diagnoses and new cardiomyopathy diagnoses. The trial began in March 2023 and outcomes will be assessed 12 months from the start of follow-up. CONCLUSION: The NOTIFY-LVH trial will assess the efficacy of a centralized intervention to improve the detection and treatment of hypertension and LVH-associated diseases. Additionally, it will serve as a proof-of-concept for how to effectively utilize previously collected electronic health data to improve the recognition and management of a broad range of chronic cardiovascular conditions. TRIAL REGISTRATION: NCT05713916.

Baseline modern medical management in the BEST-CLI trial.

OBJECTIVES: The use of optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, randomized, controlled trial sponsored by the National Institutes of Health comparing revascularization strategies in patients with CLTI. We evaluated the use of guideline-based OMT among patients with CLTI at the time of their enrollment into the trial. METHODS: A multidisciplinary committee defined OMT criteria related to blood pressure and diabetic management, lipid-lowering and antiplatelet medication use, and smoking status for patients enrolled in BEST-CLI. Status reports indicating adherence to OMT were provided to participating sites at regular intervals. Baseline demographic characteristics, comorbid medical conditions, and use of OMT at trial entry were evaluated for all randomized patients. A linear regression model was used to identify the relationship of predictors to the use of OMT. RESULTS: At the time of randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently smoking. Adherence to four OMT components (controlled blood pressure, not currently smoking, use of one lipid-lowering medication, and use of an antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 38% met three, 24% met two, 11% met only one, and 2% met none. Age ≥80 years, coronary artery disease, diabetes, and Hispanic ethnicity were positively associated, whereas Black race was negatively associated, with the use of OMT. CONCLUSIONS: A significant proportion of patients in BEST-CLI did not meet OMT guideline-based recommendations at time of entry. These data suggest a persistent major gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial and their impact on clinical outcomes and quality of life will be assessed in future analyses.

Virtual Care Team Guided Management of Patients With Heart Failure During Hospitalization.

BACKGROUND: Scalable and safe approaches for heart failure guideline-directed medical therapy (GDMT) optimization are needed. OBJECTIVES: The authors assessed the safety and effectiveness of a virtual care team guided strategy on GDMT optimization in hospitalized patients with heart failure with reduced ejection fraction (HFrEF). METHODS: In a multicenter implementation trial, we allocated 252 hospital encounters in patients with left ventricular ejection fraction ≤40% to a virtual care team guided strategy (107 encounters among 83 patients) or usual care (145 encounters among 115 patients) across 3 centers in an integrated health system. In the virtual care team group, clinicians received up to 1 daily GDMT optimization suggestion from a physician-pharmacist team. The primary effectiveness outcome was in-hospital change in GDMT optimization score (+2 initiations, +1 dose up-titrations, -1 dose down-titrations, -2 discontinuations summed across classes). In-hospital safety outcomes were adjudicated by an independent clinical events committee. RESULTS: Among 252 encounters, the mean age was 69 ± 14 years, 85 (34%) were women, 35 (14%) were Black, and 43 (17%) were Hispanic. The virtual care team strategy significantly improved GDMT optimization scores vs usual care (adjusted difference: +1.2; 95% CI: 0.7-1.8; P < 0.001). New initiations (44% vs 23%; absolute difference: +21%; P = 0.001) and net intensifications (44% vs 24%; absolute difference: +20%; P = 0.002) during hospitalization were higher in the virtual care team group, translating to a number needed to intervene of 5 encounters. Overall, 23 (21%) in the virtual care team group and 40 (28%) in usual care experienced 1 or more adverse events (P = 0.30). Acute kidney injury, bradycardia, hypotension, hyperkalemia, and hospital length of stay were similar between groups. CONCLUSIONS: Among patients hospitalized with HFrEF, a virtual care team guided strategy for GDMT optimization was safe and improved GDMT across multiple hospitals in an integrated health system. Virtual teams represent a centralized and scalable approach to optimize GDMT.

Disagreement between pharmacy claims and direct interview to identify patients with non-adherence to chronic cardiometabolic medications.

BACKGROUND: Accurate methods of identifying patients with suboptimal adherence to cardiometabolic medications are needed, and each approach has benefits and tradeoffs. METHODS: We used data from a large trial of patients with poorly controlled cardiometabolic disease and evidence of medication non-adherence measured using pharmacy claims data whose adherence was subsequently assessed during a telephone consultation with a clinical pharmacist. We then evaluated if the pharmacist assessment agreed with the non-adherence measured using claims. When pharmacist and claims assessments disagreed, we identified reasons why claims were insufficient and used multivariable modified Poisson regression to identify patient characteristics associated with disagreement. RESULTS: Of 1,069 patients identified as non-adherent using claims (proportion of days covered [PDC] <80%), 646 (60.4%) were confirmed as non-adherent on pharmacist interview. For the 423 patients (39.6%) where the interview disagreed with the claims, the most common reasons were paying cash or using an alternate insurance (36.6%), medication discontinuation or regimen change (32.8%), and recently becoming adherent (26.7%). Compared to patients whose claims and interview both showed non-adherence, patients whose interview disagreed with claims were less likely to miss outpatient office visits (RR:0.91, 95%CI:0.85-0.97) and more likely to have a baseline PDC above the median (RR:1.35, 95%CI:1.10-1.64). CONCLUSIONS: Among patients identified as non-adherent by claims, 39.6% were observed to be adherent when assessed during pharmacist consultation. This discrepancy was largely driven by paying out-of-pocket, using alternative insurance, or medication discontinuation or change. These findings have important implications for using pharmacy claims to identify and intervene upon medication non-adherence.

Clinicians' and Patients' Perspectives on Hypertension Care in a Racially and Ethnically Diverse Population in Primary Care.

Importance: Hypertension control remains suboptimal, particularly for Black and Hispanic or Latino patients. A need exists to improve hypertension management and design effective strategies to efficiently improve the quality of care in primary care, especially for these at-risk populations. Few studies have specifically explored perspectives on blood pressure management by primary care providers (PCPs) and patients. Objective: To examine clinician and patient perspectives on barriers and facilitators to hypertension control within a racially and ethnically diverse health care system. Design, Setting, and Participants: This qualitative study was conducted in a large urban US health care system from October 1, 2020, to March 31, 2021, among patients with a diagnosis of hypertension from a racially and ethnically diverse population, for a range of hypertension medication use hypertension control, as well as practicing PCPs. Analysis was conducted between June 2021 and February 2022 using immersion-crystallization methods. Main Outcomes and Measures: Perspectives on managing blood pressure, including medication adherence and lifestyle, considerations for intensification, and experiences and gaps in using health information technology tools for hypertension, were explored using semistructured qualitative interviews. These cycles of review were continued until all data were examined and meaningful patterns were identified. Results: Interviews were conducted with 30 participants: 15 patients (mean [SD] age, 58.6 [16.2] years; 10 women [67%] and 9 Black patients [60%]) and 15 clinicians (14 PCPs and 1 medical assistant; 8 women [53%]). Eleven patients (73%) had suboptimally controlled blood pressure. Participants reported a wide range of experiences with hypertension care, even within the same clinics and health care system. Five themes relevant to managing hypertension for racially and ethnically diverse patient populations in primary care were identified: (1) difficulty with self-management activities, especially lifestyle modifications; (2) hesitancy intensifying medications by both clinicians and patients; (3) varying the timing and follow-up after changes in medication; (4) variation in blood pressure self-monitoring recommendations and uptake; and (5) limited specific functionality of current health information technology tools. Conclusions and Relevance: In this qualitative study of the views of PCPs and patients on hypertension control, the participants felt that more focus should be placed on lifestyle modifications than medications for hypertension, particularly for patients from racial and ethnic minority groups. Participants also expressed concerns about the existing functionality of health information technology tools to support increasingly asynchronous hypertension care. More intentional ways of supporting treatment intensification, self-care, and follow-up care are needed to improve hypertension management for racially and ethnically diverse populations in primary care.

Reducing ethnic and racial disparities by improving undertreatment, control, and engagement in blood pressure management with health information technology (REDUCE-BP) hybrid effectiveness-implementation pragmatic trial: Rationale and design.

BACKGROUND: While racial/ethnic disparities in blood pressure control are documented, few interventions have successfully reduced these gaps. Under-prescribing, lack of treatment intensification, and suboptimal follow-up care are thought to be central contributors. Electronic health record (EHR) tools may help address these barriers and may be enhanced with behavioral science techniques. OBJECTIVE: To evaluate the impact of a multicomponent behaviorally-informed EHR-based intervention on blood pressure control. TRIAL DESIGN: Reducing Ethnic and racial Disparities by improving Undertreatment, Control, and Engagement in Blood Pressure management with health information technology (REDUCE-BP) (NCT05030467) is a two-arm cluster-randomized hybrid type 1 pragmatic trial in a large multi-ethnic health care system. Twenty-four clinics (>350 primary care providers [PCPs] and >10,000 eligible patients) are assigned to either multi-component EHR-based intervention or usual care. Intervention clinic PCPs will receive several EHR tools designed to reduce disparities delivered at different points, including a: (1) dashboard of all patients visible upon logging on to the EHR displaying blood pressure control by race/ethnicity compared to their PCP peers and (2) set of tools in an individual patient's chart containing decision support to encourage treatment intensification, ordering home blood pressure measurement, interventions to address health-related social needs, default text for note documentation, and enhanced patient education materials. The primary outcome is patient-level change in systolic blood pressure over 12 months between arms; secondary outcomes include changes in disparities and other clinical outcomes. CONCLUSION: REDUCE-BP will provide important insights into whether an EHR-based intervention designed using behavioral science can improve hypertension control and reduce disparities.