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).

A Comparison of Individuals with Diabetes and EMPA-REG Trial Participants: Exploring Aspects of External Validity.

BACKGROUND: There is increasing use of sodium glucose co-transporter 2 (SGLT2) inhibitors to treat diabetes. Since trials apply specific entry and exclusion criteria to ensure internal validity, comparisons of trial populations with nationally representative samples can inform the applicability of study findings to practice. OBJECTIVE: To compare individuals with diabetes from a nationally representative sample to patients who underwent randomization in the EMPA-REG trial. A secondary aim was to characterize what proportion of individuals prescribed an SGLT2 inhibitor in a nationally representative sample would have been included in the EMPA-REG trial. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Adults with diabetes who took part in the National Health and Nutrition Examination Survey (NHANES) between 2011-2014 (primary analysis corresponding to EMPA-REG enrollment) and 2015-2018 (secondary analysis corresponding to contemporary sample). MAIN MEASURES: The primary outcome was a comparison of demographic (age, sex, ethnicity, and pregnancy status), clinical (comorbidities and medication use), examination (weight, body mass index, and systolic and diastolic blood pressure), and laboratory (hgba1c, low- and high-density lipoprotein cholesterol, triglycerides, and estimated glomerular filtration rate) characteristics of NHANES respondents versus EMPA-REG trial participants. The secondary outcome was the proportion of NHANES respondents who had been prescribed an SGLT2 inhibitor that would have met inclusion criteria for the EMPA-REG trial. KEY RESULTS: There were 655 and 48 respondents, representing a weighted sample of 21,849,775 and 1,062,573 individuals, included in the primary and secondary analyses, respectively. Overall, 7.6% (95% CI 4.8-10.6%) of 2011-2014 NHANES respondents would have met all EMPA-REG trial inclusion criteria. NHANES respondents and EMPA-REG participants differed across demographic, clinical, examination, and laboratory domains. Of NHANES respondents from 2015 to 2018 who were prescribed an SGLT2 inhibitor, 10.6% (95% CI <1-24.7%) would have met all inclusion criteria for the EMPA-REG trial. CONCLUSIONS: The EMPA-REG population differed from a nationally representative sample, which could affect generalizability.

Association Between Pain, Blood Pressure, and Medication Intensification in Primary Care: an Observational Study.

BACKGROUND: Treating hypertension is important but physicians often do not intensify blood pressure (BP) treatment in the setting of pain. OBJECTIVE: To identify whether reporting pain is associated with (1) elevated BP at the same visit, (2) medication intensification, and (3) elevated BP at the subsequent visit. DESIGN: Retrospective cohort SETTING: Integrated health system PARTICIPANTS: Adults seen in primary care EXPOSURE: Pain status based on numerical scale: mild (1-3), moderate (4-6), or severe (≥ 7). MAIN MEASURES: We defined elevated BP as ≥ 140/80 mmHg and medication intensification as increasing the dose or adding a new antihypertensive medication. Multilevel regression models were used to find the association between pain and (1) elevated BP at the index visit; (2) medication intensification at the index visit; and (3) elevated BP at the subsequent visit. Models adjusted for demographics, chronic conditions, and clustering within physician. In the third model, we adjusted for initial systolic BP as well. KEY RESULTS: Our population included 56,322 patients; 3155 (6%) reported mild pain, 5050 (9%) reported moderate pain, and 4647 (8%) reported severe pain at the index visit. Compared with no pain, the adjusted odds ratios of elevated BP were 1.38 (95% CI: 1.28-1.48) for severe pain, 1.06 (95% CI: 0.99-1.14) for moderate pain, and 1.02 (95% CI: 0.93-1.12) for mild pain. Adjusted odds ratios of medication intensification at the index visit were 0.65 (95% CI: 0.54-0.80) for mild pain, 0.61 (95% CI: 0.52-0.72) for moderate pain, and 0.55 (95% CI: 0.47-0.64) for severe pain. Among patients with elevated BP at the index visit, reporting pain at the index visit was not associated with elevated BP at the subsequent visit. CONCLUSIONS: When patients reported pain, physicians were less likely to intensify antihypertensive treatment; nevertheless, patients reporting pain were not more likely to have elevated BP at the subsequent visit.

Attitudes of High Versus Low Antibiotic Prescribers in the Management of Upper Respiratory Tract Infections: a Mixed Methods Study.

IMPORTANCE: Inappropriate antibiotic use for upper respiratory tract infections (URTIs) is an ongoing problem in primary care. There is extreme variation in the prescribing practices of individual physicians, which cannot be explained by clinical factors. OBJECTIVE: To identify factors associated with high and low prescriber status for management of URTIs in primary care practice. DESIGN AND PARTICIPANTS: Exploratory sequential mixed-methods design including interviews with primary care physicians in a large health system followed by a survey. Twenty-nine physicians participated in the qualitative interviews. Interviews were followed by a survey in which 109 physicians participated. MAIN MEASURES: Qualitative interviews were used to obtain perspectives of high and low prescribers on factors that influenced their decision making in the management of URTIs. A quantitative survey was created based on qualitative interviews and responses compared to actual prescribing rates. An assessment of self-prescribing pattern relative to their peers was also conducted. RESULTS: Qualitative interviews identified themes such as clinical factors (patient characteristics, symptom duration, and severity), nonclinical factors (physician-patient relationship, concern for patient satisfaction, preference and expectation, time pressure), desire to follow evidence-based medicine, and concern for adverse effects to influence prescribing. In the survey, reported concern regarding antibiotic side effects and the desire to practice evidence-based medicine were associated with lower prescribing rates whereas reported concern for patient satisfaction and patient demand were associated with high prescribing rates. High prescribers were generally unaware of their high prescribing status. CONCLUSIONS AND RELEVANCE: Physicians report that nonclinical factors frequently influence their decision to prescribe antibiotics for URTI. Physician concerns regarding antibiotic side effects and patient satisfaction are important factors in the decision-making process. Changes in the health system addressing both physicians and patients may be necessary to attain desired prescribing levels.

Population-Based Trends in Prevalence of Nonalcoholic Fatty Liver Disease in US Adults With Type 2 Diabetes.

Type 2 diabetes (T2D) affects more than 9% of U.S. adults.1 Nonalcoholic fatty liver disease (NAFLD) has been recognized as a common co-morbidity in T2D. However, most previous epidemiologic studies have been subject to ascertainment and selection bias or had small sample sizes. No recent studies have examined trends of the burden of NAFLD in diabetic patients. Using noninvasive scores and the National Health and Nutrition Examination Survey (NHANES), we aimed to estimate the population-based trends in prevalence of NAFLD-associated comorbidities in U.S. adults with T2D.

Physician Empathy Is Not Associated with Laboratory Outcomes in Diabetes: a Cross-sectional Study.

BACKGROUND: One widely cited study suggested a link between physician empathy and laboratory outcomes in patients with diabetes, but its findings have not been replicated. While empathy has a positive impact on patient experience, its impact on other outcomes remains unclear. OBJECTIVE: To assess associations between physician empathy and glycosylated hemoglobin (HgbA1c) as well as low-density lipoprotein (LDL) levels in patients with diabetes. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Patients with diabetes who received care at a large integrated health system in the USA between January 1, 2011, and May 31, 2014, and their primary care physicians. MAIN MEASURES: The main independent measure was physician empathy, as measured by the Jefferson Scale of Empathy (JSE). The JSE is scored on a scale of 20-140, with higher scores indicating greater empathy. Dependent measures included patient HgbA1c and LDL. Mixed-effects linear regression models adjusting for patient sociodemographic characteristics, comorbidity index, and physician characteristics were used to assess the association between physician JSE scores and their patients' HgbA1c and LDL. KEY RESULTS: The sample included 4176 primary care patients who received care with one of 51 primary care physicians. Mean physician JSE score was 118.4 (standard deviation (SD) = 12). Median patient HgbA1c was 6.7% (interquartile range (IQR) = 6.2-7.5) and median LDL concentration was 83 (IQR = 66-104). In adjusted analyses, there was no association between JSE scores and HgbA1c (ß = - 0.01, 95%CI = - 0.04, 0.02, p = 0.47) or LDL (ß = 0.41, 95%CI = - 0.47, 1.29, p = 0.35). CONCLUSION: Physician empathy was not associated with HgbA1c or LDL. While interventions to increase physician empathy may result in more patient-centered care, they may not improve clinical outcomes in patients with diabetes.

Frequency, Timing, and Types of Medication Ordering Errors Made by Residents in the Electronic Medical Records Era.

OBJECTIVES: To describe associations between resident level of training, timing of medication orders, and the types of inpatient medication ordering errors made by internal medicine residents. METHODS: This study reviewed all inpatient medication orders placed by internal medicine residents at a tertiary care academic medical center from July 2011 to June 2015. Medication order errors were measured by pharmacists' reporting of an error via the electronic medical record during real-time surveillance of orders. Multivariable regression models were constructed to assess associations between resident training level (postgraduate year [PGY]), medication order timing (time of day and month of year), and rates of medication ordering errors. RESULTS: Of 1,772,462 medication orders placed by 335 residents, 68,545 (3.9%) triggered a pharmacist intervention in the electronic medical record. Overall and for each PGY level, renal dose monitoring/adjustment was the most common order error (40%). Ordering errors were less frequent during the night and transition periods versus daytime (adjusted odds ratio [aOR] 0.93, 95% confidence interval [CI] 0.91-0.96, and aOR 0.93, 95% CI 0.90-0.95, respectively). Errors were more common in July and August compared with other months (aOR 1.05, 95% CI 1.01-1.09). Compared with PGY2 residents, both PGY1 (aOR 1.06, 95% CI 1.03-1.10), and PGY3 residents (aOR 1.07, 95% CI, 1.03-1.10) were more likely to make medication ordering errors. Throughout the course of the academic year, the odds of a medication ordering error decreased by 16% (aOR 0.84, 95% CI 0.80-0.89). CONCLUSIONS: Despite electronic medical records, medication ordering errors by trainees remain common. Additional supervision and resident education regarding medication orders may be necessary.

Thromboembolic and Major Bleeding Events With Rivaroxaban Versus Warfarin Use in a Real-World Setting.

BACKGROUND: Although randomized trials demonstrate the noninferiority of rivaroxaban compared with warfarin in the context of nonvalvular atrial fibrillation (AF), little is known about how these drugs compare in practice. OBJECTIVE: To assess the relative effectiveness and safety of rivaroxaban versus warfarin in a large health system and to evaluate this association by time in therapeutic range (TTR). METHODS: We conducted a retrospective cohort study with propensity matching in the Cleveland Clinic Health System. The study included patients initiated on warfarin or rivaroxaban for thromboembolic prevention in nonvalvular AF between January 2012 and July 2016. The main outcomes were thromboembolic events and major bleeds. Analyses were stratified by warfarin patients' TTR. RESULTS: The cohort consisted of 472 propensity-matched pairs. The mean age was 73.6 years (SD = 11.7), and the mean CHADS2 score was 1.8. The median TTR for warfarin patients was 64%. In the propensity-matched analysis, there was no significant difference in thromboembolic or major bleeding events between groups. Among warfarin patients with a TTR <64% and their matched rivaroxaban pairs, there was also no significant difference in thromboembolic or major bleeding events. CONCLUSIONS: Under real-world conditions, warfarin and rivaroxaban were associated with similar safety and effectiveness, even among those with suboptimal therapeutic control. Individualized decision making, taking into account the nontherapeutic tradeoffs associated with these medications (eg, monitoring, half-life, cost) is warranted.

Prevalence and Predictors of Depression Among Patients With Epilepsy, Stroke, and Multiple Sclerosis Using the Cleveland Clinic Knowledge Program Within the Neurological Institute.

BACKGROUND: Neurological conditions carry a high risk of depression. Given this risk, the Neurological Institute (NI) at Cleveland Clinic has initiated systematic screening for depression using the 9-item Patient Health Questionnaire-9 (PHQ-9) embedded within its electronic medical record and its data capture system, the Knowledge Program (KP)1. OBJECTIVE: We sought to (1) estimate the prevalence of depression among patients with epilepsy, stroke, and multiple sclerosis (MS); (2) identify risk factors for depression within each disease; and (3) determine differential risks and predictors across neurological disorders. METHODS: The KP1 database provided information on approximately 23,000 visits involving 7946 outpatients with epilepsy, stroke, or MS seen in neurology specialty clinics. The primary outcome measure was depression as defined as a PHQ-9 ≥ 10. RESULTS: Overall, the point prevalence of depression was 29.0%. For stroke, epilepsy, and MS, prevalence of depression was 23% (95% CI: 21-25%), 33% (95% CI: 31-35%), and 29% (95% CI: 28-30%), respectively. For all 3 conditions, increasing disease severity and decreased health-related quality of life were independent predictors of depression. In multivariable models, there was a significant interaction between age and condition, and condition with disease severity. In stroke and MS, increasing age was associated with reduced odds for depression, whereas in epilepsy, increasing age was associated with an increased odds for depression. CONCLUSIONS: Although depression is common among patients with neurological disorders, our data suggest that predictors of depression such as age and disease severity varied by condition, supporting important possible phenomenological and pathophysiological differences of depression across these neurological conditions.

Characterization of Patient Interest in Provider-Based Consumer Health Information Technology: Survey Study.

BACKGROUND: Consumer health information technology can improve patient engagement in their health care and assist in navigating the complexities of health care delivery. However, the consumer health information technology offerings of health systems are often driven by provider rather than patient perspectives and inadequately address patient needs, thus limiting their adoption by patients. Consideration given to patients as stakeholders in the development of such technologies may improve adoption, efficacy, and consumer health information technology resource allocation. OBJECTIVE: The aims of this paper were to measure patient interest in different health system consumer health information technology apps and determine the influence of patient characteristics on consumer health information technology interest. METHODS: Patients seen at the Cleveland Clinic Neurological Institute were electronically surveyed on their interest in using different consumer health information technology apps. A self-efficacy scale, Patient Health Questionnaire-9 depression screen, and EuroQol 5 dimensions health-related quality of life scale were also completed by patients. Logistic regression was used to determine the influence of patient characteristics on interest in consumer health information technology in the categories of self-management, education, and communication. RESULTS: The majority of 3852 patient respondents had an interest in all technology categories assessed in the survey. The highest interest was in apps that allow patients to ask questions of providers (3476/3852, 90.24%) and to schedule appointments (3211/3839, 83.64%). Patient interest in consumer health information technology was significantly associated with greater depression symptoms, worse quality of life, greater health self-efficacy, and smartphone ownership (P<.001 for all listed). CONCLUSIONS: Patients should be viewed as active stakeholders in consumer health information technology development and their perspectives should consistently guide development efforts. Health systems should consider focusing on consumer health information technologies that assist patients in scheduling appointments and asking questions of providers. Patients with depression should also be considered for targeted consumer health information technology implementation. Health self-efficacy is a valid predictor of consumer health information technology interest and may play a role in the utilization of consumer health information technologies. Health systems, broadly, should put forth greater effort to understand the needs and interests of patients in the consumer health information technology development process. Consumer health information technology design and implementation may be improved by understanding which technologies patients want.

Prevalence of Iron Deficiency and Iron-Deficiency Anemia in US Females Aged 12-21 Years, 2003-2020.

This study examines prevalence of iron deficiency among females aged 12 to 21 years to inform future screening strategies for iron deficiency and iron-deficiency anemia.