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).

Age-based disparities in statin use for primary prevention in US adults: National Health and Nutrition Examination Surveys 2013-2020.

Statin use among younger adults at high atherosclerotic cardiovascular disease (ASCVD) risk compared with older adults at the same risk is unclear. We determined prevalent statin use by 10-year ASCVD risk and age among US participants aged 40-75 eligible for risk-indicated primary prevention statins from the 2013-2020 National Health and Nutrition Examination Survey cycles. Among 3,503 participants, statin use by ASCVD risk (5-<7.5%, 7.5-<20%, and ≥20%) was 9.4%, 9.0%, and 12.2% among those age 40-54 compared to 22.0%, 23.9%, and 14.3% among adults 55-64 years and 39.3%, 33.6%, and 38.1% age 65-75 years. After adjusting for sociodemographic and healthcare access, the prevalence ratio (vs. 65-75 years) for statin use among adults with an ASCVD risk of 7.5-<20% age 40-54 years was 0.40 (95% confidence interval [CI] 0.39,0.41) and 0.87 (95% CI 0.87,0.88) for adults 55-64 years. Among high ASCVD-risk adults aged 40-75 years, primary prevention statin use was lower among adults <65 years despite similar ASCVD risk as older adults.

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.

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.

Performance of crisis standards of care guidelines in a cohort of critically ill COVID-19 patients in the United States.

Many US states published crisis standards of care (CSC) guidelines for allocating scarce critical care resources during the COVID-19 pandemic. However, the performance of these guidelines in maximizing their population benefit has not been well tested. In 2,272 adults with COVID-19 requiring mechanical ventilation drawn from the Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (STOP-COVID) multicenter cohort, we test the following three approaches to CSC algorithms: Sequential Organ Failure Assessment (SOFA) scores grouped into ranges, SOFA score ranges plus comorbidities, and a hypothetical approach using raw SOFA scores not grouped into ranges. We find that area under receiver operating characteristic (AUROC) curves for all three algorithms demonstrate only modest discrimination for 28-day mortality. Adding comorbidity scoring modestly improves algorithm performance over SOFA scores alone. The algorithm incorporating comorbidities has modestly worse predictive performance for Black compared to white patients. CSC algorithms should be empirically examined to refine approaches to the allocation of scarce resources during pandemics and to avoid potential exacerbation of racial inequities.

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.