Faculty Bibliography

BACKGROUND:Medication nonadherence is a common issue among patients with hypertension. Healthcare professionals often overlook medication nonadherence due to limited tools, time constraints, and competing demands. Integrating pharmacy medication fill data into electronic health records (EHRs) presents an opportunity to enhance medication adherence measurement and monitoring in real-time. This study identified facilitators and barriers to addressing adherence to antihypertensive medications by Medical Assistants (MAs), Registered Nurses (RNs), and Primary Care Providers (PCPs) in primary care settings. METHODS:We conducted a qualitative study with, 15 healthcare professionals (5 MAs, 5 RNs, and 5 PCPs) caring for patients with hypertension. Semi-structured interviews, guided by the Consolidated Framework for Implementation Research (CFIR), explored barriers and facilitators related to screening and addressing medication non-adherence during primary care clinical encounters. Thematic analysis and deductive coding were used to analyze the data. RESULTS:Four major themes emerged: motivation, work infrastructure, capability, and opportunity. MAs and PCPs were motivated to discuss medication adherence and build relationships. Capability varied; RNs were confident in their counseling skills based on their training and patient trust, and PCPs described adherence counseling as part of their role, particularly through motivational interviewing. Work infrastructure presented structural hurdles due to RN workflow limitations and MA role constraints. Opportunity to address non-adherence were constrained by tight schedules and competing clinical demands during brief visits. CONCLUSIONS:RNs and PCPs felt capable in their ability to address medication adherence but cited time and competing demands as significant barriers; conversely, MAs reported motivation but were limited by their role. These findings suggest opportunities for effective management of medication adherence in practice settings through a more coordinated strategy across multiple healthcare professionals. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov; NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422.

BACKGROUND:Patients with heart failure (HF) often have difficulty obtaining life-saving medications due to coverage barriers, such as prior authorizations and high out-of-pocket costs. To promote better coverage for high value therapies and inform policymakers about cost effectiveness, the American Heart Association/American College of Cardiology/Heart Failure Society of America added Value Statements to HF guidelines. We assessed whether these guidelines influenced Medicare drug coverage policies for 2 life-saving, costly HF medications: angiotensin receptor neprilysin inhibitors (ARNI-guideline "high value") and sodium glucose cotransporter-2 inhibitors (SGLT2i-guideline "intermediate value"). METHODS:We performed an observational study using Medicare prescription drug plan formulary files from April 2020 to April 2023 to separately assess for changes in coverage barriers to ARNI and SGLT2i after Value Statement publication (April 2022), and subsequent Medicare plan online update (October 2022). The primary outcome was the percentage of plans each month with any barrier to drug coverage (prior authorizations, tier ≥3 out-of-pocket cost-sharing, step therapy, or no coverage). Analyses used interrupted time series and difference-in-differences approaches. Difference-in-differences analyses used direct oral anticoagulants as a control due to their comparable cost and use as ARNI and SGLT2i, but without a Value Statement. RESULTS:Among 7396 Medicare drug plans, monthly rates of any coverage barrier ranged from 94.3% to 97.4% for ARNI and 93.2% to 96.6% for SGLT2i. Most barriers were due to tier ≥3 out-of-pocket cost-sharing requirements (ARNI: 94.3%-95.8%; SGLT2i: 93.2%-95.6%). Coverage barriers remained stable in April 2022 and declined slightly in October 2022. In difference-in-differences analyses, the presence of a Value Statement was associated with a ~1 percentage point decline in coverage barriers for both ARNI (difference-in-differences estimate, -1.07% [95% CI, -1.44% to -0.70%]) and SGLT2i (-1.32% [95% CI, -1.63% to -1.00%]). CONCLUSIONS:Coverage barriers to ARNI and SGLT2i were common and changed only slightly after publication of Value Statements in HF guidelines. There is a critical need for robust strategies to improve access to life-saving HF medications.

Despite progress to define primary care practice transformation models, there remain gaps in translating evidence-based guidelines into routine clinical care. Primary care providers (MD, DO, NP, PA) and researchers need tools to assess modifiable factors that improve practice performance to inform practice transformation efforts. We aimed to develop a pragmatic tool for assessing practice-level primary care structures and processes that are associated with better care quality and clinical outcomes. We generated 314 candidate items for the Tool for Advancing Practice Performance (TAPP) using data from a comprehensive literature review, Delphi study, and qualitative interviews with high-performing practices. We used empirical criteria and expert review to eliminate redundancy and improve clarity via removing and retaining items. The retained items were formatted into a survey tool, and we further revised the tool based on feedback elicited from cognitive interviews and pilot testing with primary care providers and staff. The final candidate pool comprised 126 items after refinement and expert review. For the survey tool, we adapted and developed survey questions for each of the 126 items. Eight cognitive interview participants reviewed the tool and provided feedback on its content and language. Based on this feedback, we eliminated 13 items because they were poorly or incorrectly understood by participants, resulting in a 113-item tool. Fifteen participants pilot tested the tool and no additional items were eliminated. The TAPP is a novel, low-burden tool that researchers and primary care providers can use to identify areas for improvement at the practice-level. Practices and health systems could use the TAPP to assess their own performance and identify gaps in their structures and processes, and practice networks and health systems can use the tool to assess structures and processes at individual clinics, track this information over time, and evaluate its relationship to care quality and clinical outcomes.

The effectiveness of COVID-19 vaccination in children and adolescents with prior SARS-CoV-2 infection remains unclear, particularly for Omicron subvariants. We evaluated vaccine effectiveness against reinfection with Omicron BA.1/2, BA.4/5, XBB, and later subvariants among 5- to 17-year-olds using data from the RECOVER initiative, a national electronic health record database covering 37 U.S. pediatric institutions. We emulated target trials by age group and variant period, comparing previously infected participants between January 2022 and August 2023. During the BA.1/2 period, vaccination reduced the risk of reinfection, with effectiveness rates of 62% in children and 65% in adolescents. During the BA.4/5 period, protection effectiveness in children was 57%, whereas no statistically significant protection was observed in adolescents. During the XBB or later period, no significant protection was observed in either group. In summary, COVID-19 vaccination provided protection against reinfection during early and mid-Omicron periods in previously infected pediatric populations, but effectiveness declined for later variants.

IMPORTANCE/OBJECTIVE:Prior studies have demonstrated the effectiveness of COVID-19 vaccines in children and adolescents. However, the benefits of vaccination in these age groups with prior infection remain underexplored. OBJECTIVE:To evaluate the effectiveness of COVID-19 vaccination in preventing reinfection with various Omicron subvariants (BA.1/2, BA.4/5, XBB, and later) among 5- to 17-year-olds with prior SARS-CoV-2 infection. DESIGN/METHODS:A target trial emulation through nested designs with distinct study periods. SETTING/METHODS:The study utilized data from the Research COVID to Enhance Recovery (RECOVER) initiative, a national electronic health record (EHR) database comprising 37 U.S. children's hospitals and health institutions. PARTICIPANTS/METHODS:Individuals aged 5-17 years with a documented history of SARS-CoV-2 infection prior to the study start date during a specific variant-dominant period (Delta, BA.1/2, or BA.4/5) who received a subsequent dose of COVID-19 vaccine during the study periods were compared with those with a documented history of infection who did not receive SARS-CoV-2 vaccine during the study period. Those infected within the Delta-Omicron composite period (December 1, 2021, to December 31, 2021) were excluded. The study period was from January 1, 2022, to August 30, 2023, and focused on adolescents aged 12 to 17 years and children aged 5 to 11 years. EXPOSURES/METHODS:At least received one COVID-19 vaccination during the study period vs. no receipt of any COVID-19 vaccine during the study period. MAIN OUTCOMES AND MEASURES/METHODS:The primary outcome is documented SARS-CoV-2 reinfection during the study period (both asymptomatic and symptomatic cases). The effectiveness of the COVID-19 vaccine was estimated as (1- hazard ratio) *100%, with confounders adjusted by a combination of propensity score matching and exact matching. RESULTS:The study analyzed 87,573 participants during the BA.1/2 period, 229,326 during the BA.4/5 period, and 282,981 during the XBB or later period. Among vaccinated individuals, significant protection was observed during the BA.1/2 period, with effectiveness rates of 62% (95% CI: 38%-77%) for children and 65% (95% CI: 32%-81%) for adolescents. During the BA.4/5 period, vaccine effectiveness was 57% (95% CI: 25%-76%) for children, but not statistically significant for adolescents (36%, 95% CI: -16%-65%). For the XBB period, no significant protection was observed in either group, with effectiveness rates of 22% (95% CI: -36%-56%) in children and 34% (95% CI: -10%-61%) in adolescents. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:COVID-19 vaccination provides significant protection against reinfection for children and adolescents with prior infections during the early and mid-Omicron periods. This study also highlights the importance of addressing low vaccination rates in pediatric populations to enhance protection against emerging variants.

Uncontrolled hypertension is common and frequently related to inadequate adherence to prescribed medications, resulting in suboptimal blood pressure control and increased healthcare utilization. Although healthcare providers have the opportunity to improve medication adherence, they may lack the tools to address adherence at the point of care. This study aims to assess the usability of a digital tool designed to improve medication adherence and blood pressure control among patients with hypertension who are not adherent to therapy. By evaluating usability, the study seeks to refine the tool's design, underscore the role of technology in managing hypertension, and provide insights to inform clinical decisions.We performed qualitative usability testing of an electronic health record (EHR)-integrated intervention with medical assistants (MAs) and primary care providers (PCPs) from a large integrated health system. Usability was assessed with these end-users using the "think aloud" and "near live" approaches. This evaluation was guided by two frameworks: the End-User Computing Satisfaction Index (EUCSI) and the Technology Acceptance Model (TAM). Interviews were analyzed using a thematic analysis approach.Thematic saturation was reached after usability testing was performed with 10 participants, comprising 5 PCPs and 5 MAs. The study identified several strengths within the content, format, ease of use, timeliness, accuracy, and usefulness of the tool, including the user-friendly content presentation, the usefulness of adherence information, and timely alerts that fit into the workflow. Challenges centered around alert visibility and specificity of information.Leveraging the two conceptual frameworks (TAM and EUCSI) to test the usability of the medication adherence tool was helpful. The tool's several strengths and opportunities for improvement were found. The resulting suggestions will be used to support the enhancement of the design for optimal implementation in a clinical trial.

BACKGROUND:One hypothesis for the respiratory syncytial virus (RSV) surge in 2022 was suppression of immune responses following SARS-CoV-2 infection. Our objective was to compare the risk of subsequent RSV and other infections among children with and without SARS-CoV-2 infection. METHODS:We conducted a retrospective cohort study using electronic health record data from 27 US health systems analyzing children aged under 5 years with SARS-CoV-2 infection (test/coded) between March and July 2022. The comparison groups were children with (a) influenza infection and (b) respiratory tract infection with no evidence of SARS-CoV-2/influenza infection. The primary and secondary outcomes were RSV infection and respiratory or any infection in the subsequent 15 to 180 days, respectively. We applied inverse probability of treatment weighting and performed weighted logistic regression modeling. RESULTS:Our primary and secondary cohorts consisted of 18 767 and 114 414 children with SARS-CoV-2 infection, and 6697 and 30 424 with influenza infection, respectively, and 46 697 with another acute respiratory tract infection. The odds of subsequent RSV were lower in the SARS-CoV-2 group compared with the influenza group (adjusted odds ratio [aOR] 0.73, 95% CI 0.61-0.86) and compared with the group with any respiratory tract infection (aOR 0.78, 95% CI 0.7-0.87). The odds of a respiratory tract infection and any infection were lower in the SARS-CoV-2 group than the influenza group (aOR 0.62, 95% CI 0.59-0.64 and aOR 0.67, 95% CI 0.65-0.7, respectively). CONCLUSIONS:We did not find an increased risk of RSV or a respiratory or any type of infection within 6 months of SARS-CoV-2 infection, compared with influenza and other respiratory illnesses.

BACKGROUND:Despite the widespread use of electronic health records, a standardized approach to identify heart failure patients is lacking. We sought to create and validate definitions for identifying patients with heart failure using electronic health record data. METHODS:To define heart failure, we developed 8 distinct definitions created from combinations of heart failure diagnosis based on ICD-10 codes listed in the clinical encounter, problem list or past medical history, and/or ejection fraction ≤40%. To validate our definitions, we used stratified sampling and physician chart review guided by the Universal Definition of Heart Failure as our gold standard and compared their performance using sensitivity and positive predictive value. RESULTS:We identified 41,392 patients who met at least one of our eight definitions for heart failure, plus an additional 2,692 patients with an ICD-10 diagnosis of heart failure outside of a standard clinical setting and 696,896 patients with a cardiovascular diagnosis other than heart failure. Using these groups, we randomly sampled a total of 528 charts for physician chart review. Sensitivities of the eight definitions of heart failure ranged from 10.3% to 42.0%, and positive predictive values ranged from 80.7% to 98.6%. CONCLUSIONS:We found that patients meeting EHR-based definitions of heart failure likely represented true clinical cases of disease. Nevertheless, the definitions captured less than half of the patients with heart failure, thus severely underestimating the prevalence of disease and underlining a need for more comprehensive methods to effectively use this data to understand the epidemiological burden of heart failure.

The COVID-19 pandemic has been associated with increased neuropsychiatric conditions in children and youths, with evidence suggesting that SARS-CoV-2 infection may contribute additional risks beyond pandemic stressors. This study aims to assess the full spectrum of neuropsychiatric conditions in COVID-19 positive children (ages 5-12) and youths (ages 12-20) compared to a matched COVID-19 negative cohort, accounting for factors influencing infection risk. Using EHR data from 25 institutions in the RECOVER program, we conduct a retrospective analysis of 326,074 COVID-19 positive and 887,314 negative participants matched for risk factors and stratified by age. Neuropsychiatric outcomes are examined 28 to 179 days post-infection or negative test between March 2020 and December 2022. SARS-CoV-2 positivity is confirmed via PCR, serology, or antigen tests, while negativity requires negative test results and no related diagnoses. Risk differences reveal higher frequencies of neuropsychiatric conditions in the COVID-19 positive cohort. Children face increased risks for anxiety, OCD, ADHD, autism, and other conditions, while youths exhibit elevated risks for anxiety, suicidality, depression, and related symptoms. These findings highlight SARS-CoV-2 infection as a potential contributor to neuropsychiatric risks, emphasizing the importance of research into tailored treatments and preventive strategies for affected individuals.

IMPORTANCE/UNASSIGNED:Medication nonadherence is present in nearly half of patients with hypertension but is underrecognized in clinical care. Data linkages between electronic health records and pharmacies have created opportunities for scalable assessment of medication adherence at the point of care. OBJECTIVE/UNASSIGNED:To test the effectiveness of a multicomponent intervention that identified patients with uncontrolled hypertension and medication nonadherence using linked electronic health record-pharmacy data combined with team-based care to address adherence barriers. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:TEAMLET (Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence) was a pragmatic, 2-arm, cluster randomized clinical trial conducted between October 2022 and November 2024 in 10 primary care sites in New York. The study included adults with uncontrolled hypertension and low medication adherence, defined as proportion of days covered (PDC) less than 80%. Data analysis was performed from November 2024 to January 2025. INTERVENTION/UNASSIGNED:The intervention consisted of the following: (1) automated identification of patients with medication nonadherence at the time of the visit; (2) prompting of medical assistants to screen for barriers to adherence; (3) clinical decision support alerting the primary care physicians and nurse practitioners to barriers to adherence; and (4) adherence discussion between the primary care physician or nurse practitioner and the patient. The comparator was usual care. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in PDC from baseline to 12 months. RESULTS/UNASSIGNED:Among 1726 patients (mean [SD] age, 67.2 [13.9] years; 887 [51.4%] female), the mean (SD) baseline PDC was 33.2% (30.5%) overall (32.4% [30.4%] in the intervention group and 34.0% [30.6%] in the control group). The mean (SD) PDC at 12 months was 51.1% (39.5%) for the intervention group and 53.1% (39.6%) for the control group. No difference was found in the change in PDC from baseline to 12 months between the intervention and control groups (mean [SD] absolute change in PDC, 18.5 [41.1] vs 18.2 [40.9] percentage points, respectively; adjusted difference, -0.15 percentage point; 95% CI, -4.06 to 3.76 percentage points). Change in systolic blood pressure and patients who became adherent (PDC ≥80%) at 12 months were also similar between groups. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this pragmatic trial, an intervention that combined team-based primary care with automated identification of patients with antihypertensive medication nonadherence did not lead to improvements in adherence or blood pressure. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT05349422.