Predicting short-term outcomes after transcatheter aortic valve replacement for aortic stenosis.

BACKGROUND: The approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population. METHODS: We identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes. RESULTS: We identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes. CONCLUSIONS: Despite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.

Study What You Do: Developing a Psychotherapy Tracking Database in a Large-Scale Integrated Behavioral Health Service.

PURPOSE: Many individuals with behavioral health challenges receive services in primary care, and integrated behavioral health (IBH) programs can help increase access to evidence-based interventions. IBH programs can benefit substantially from integrating standardized tracking databases that allow for the implementation of measurement-based care to evaluate patient-, clinician-, and practice-level outcomes. We describe the development and integration of Mayo Clinic's pediatric and adult primary care psychotherapy tracking database. METHODS: IBH practice leaders directed the development of a large psychotherapy tracking database that continuously populates from Mayo Clinic's electronic health record system. The database captures numerous patient variables including demographics, behavioral health and substance use issues, psychotherapy principles used, and self-reported symptoms. We retrieved current data for patients empaneled in Mayo Clinic's pediatric and adult primary care psychotherapy programs from June 2014 to June 2022. RESULTS: The tracking database contained data for 16,923 adult patients and 6,298 pediatric patients. The mean age of adult patients was 43.2 years (SD 18.3), 88.1% were non-Latine White, and 66.7% identified as female. The mean age of pediatric patients was 11.6 years (SD 4.2), 82.5% were non-Latine White, and 56.9% identified as female. We provide examples of practical applications of the database across clinical, educational, research, and administrative domains. CONCLUSIONS: The development and integration of a psychotherapy tracking database supports clinician communication, examination of patient outcomes, practice quality improvement efforts, and clinically relevant research. Our description of Mayo Clinic's IBH database may serve as a model for other IBH practices.

Guideline-Directed Medical Therapy in Newly Diagnosed Heart Failure With Reduced Ejection Fraction in the Community.

BACKGROUND: Guideline-directed medical therapy (GDMT) dramatically improves outcomes in heart failure with reduced ejection fraction (HFrEF). Our goal was to examine GDMT use in community patients with newly diagnosed HFrEF. METHODS AND RESULTS: We performed a population-based, retrospective cohort study of all Olmsted County, Minnesota, residents with newly diagnosed HFrEF (EF ≤ 40%) 2007-2017. We excluded patients with contraindications to medication initiation. We examined the use of beta-blockers, HF beta-blockers (metoprolol succinate, carvedilol, bisoprolol), angiotensin converting enzyme inhibitors (ACEis), angiotensin receptor blockers (ARBs), angiotensin receptor neprilysin inhibitors (ARNIS), and mineralocorticoid receptor antagonists (MRAs) in the first year after HFrEF diagnosis. We used Cox models to evaluate the association of being seen in an HF clinic with the initiation of GDMT. From 2007 to 2017, 1160 patients were diagnosed with HFrEF (mean age 69.7 years, 65.6% men). Most eligible patients received beta-blockers (92.6%) and ACEis/ARBs/ARNIs (87.0%) in the first year. However, only 63.8% of patients were treated with an HF beta-blocker, and few received MRAs (17.6%). In models accounting for the role of an HF clinic in initiation of these medications, being seen in an HF clinic was independently associated with initiation of new GDMT across all medication classes, with a hazard ratio (95% CI) of 1.54 (1.15-2.06) for any beta-blocker, 2.49 (1.95-3.20) for HF beta-blockers, 1.97 (1.46-2.65) for ACEis/ARBs/ARNIs, and 2.14 (1.49-3.08) for MRAs. CONCLUSIONS: In this population-based study, most patients with newly diagnosed HFrEF received beta-blockers and ACEis/ARBs/ARNIs. GDMT use was higher in patients seen in an HF clinic, suggesting the potential benefit of referral to an HF clinic for patients with newly diagnosed HFrEF.

Association of Patient and System-Level Factors With Social Determinants of Health Screening.

BACKGROUND: Health systems are increasingly recognizing the importance of collecting social determinants of health (SDoH) data. However, gaps remain in our understanding of facilitators or barriers to collection. To address these gaps, we evaluated a real-world implementation of a SDoH screening tool. METHODS: We conducted a retrospective analysis of the implementation of the SDoH screening tool at Mayo Clinic in 2019. The outcomes are: (1) completion of screening and (2) the modality used (MyChart: filled out on patient portal; WelcomeTablet: filled out by patient on a PC-tablet; EpicCare: data obtained directly by provider and entered in chart). We conducted logistic regression for completion and multinomial logistic regression for modality. The factors of interest included race and ethnicity, use of an interpreter, and whether the visit was for primary care. RESULTS: Overall, 58.7% (293,668/499,931) of screenings were completed. Patients using interpreters and racial/ethnic minorities were less likely to complete the screening. Primary care visits were associated with an increase in completion compared with specialty care visits. Patients who used an interpreter, racial and ethnic minorities, and primary care visits were all associated with greater WelcomeTablet and lower MyChart use. CONCLUSION: Patient and system-level factors were associated with completion and modality. The lower completion and greater WelcomeTablet use among patients who use interpreters and racial and ethnic minorities points to the need to improve screening in these groups and that the availability of the WelcomeTablet may have prevented greater differences. The higher completion in primary care visits may mean more outreach is needed for specialists.

A Comparison of Self-reported Medication Adherence to Concordance Between Part D Claims and Medication Possession.

OBJECTIVE: Medicare Part D claims indicate medication purchased, but people who are not fully adherent may extend prescription use beyond the interval prescribed. This study assessed concordance between Part D claims and medication possession at a study visit in relation to self-reported medication adherence. MATERIALS AND METHODS: We matched Part D claims for 6 common medications to medications brought to a study visit in 2011-2013 for the Atherosclerosis Risk in Communities study. The combined data consisted of 3027 medication events (claims, medications possessed, or both) for 2099 Atherosclerosis Risk in Communities study participants. Multinomial logistic regression estimated the association of concordance (visit only, Part D only, or both) with self-reported medication adherence while controlling for sociodemographic characteristics, veteran status, and availability under Generic Drug Discount Programs. RESULTS: Relative to participants with high adherence, medication events for participants with low adherence were approximately 25 percentage points less likely to match and more likely to be visit only (P<0.001). The results were similar but smaller in magnitude (approximately 2-3 percentage points) for participants with medium adherence. Compared with females, medication events for male veterans were approximately 11 percentage points less likely to match and more likely to be visit only. Events for medications available through Generic Drug Discount Programs were 3 percentage points more likely to be visit only. CONCLUSIONS: Part D claims were substantially less likely to be concordant with medications possessed at study visit for participants with low self-reported adherence. This result supports the construction of adherence proxies such as proportion days covered using Part D claims.

Mind the Gap: Hospitalizations from Multiple Sources in a Longitudinal Study.

BACKGROUND: Medicare claims and prospective studies with self-reported utilization are important sources of hospitalization data for epidemiologic and outcomes research. OBJECTIVES: To assess the concordance of Medicare claims merged with interview-based surveillance data to determine factors associated with source completeness. METHODS: The Atherosclerosis Risk in Communities (ARIC) study recruited 15,792 cohort participants aged 45 to 64 years in the period 1987 to 1989 from four communities. Hospitalization records obtained through cohort report and hospital record abstraction were matched to Medicare inpatient records (MedPAR) from 2006 to 2011. Factors associated with concordance were assessed graphically and using multinomial logit regression. RESULTS: Among fee-for-service enrollees, MedPAR and ARIC hospitalizations matched approximately 67% of the time. For Medicare Advantage enrollees, completeness increased after initiation of hospital financial incentives in 2008 to submit shadow bills for Medicare Advantage enrollees. Concordance varied by geographic site, age, veteran status, proximity to death, study attrition, and whether hospitalizations were within ARIC catchment areas. CONCLUSIONS: ARIC and MedPAR records had good concordance among fee-for-service enrollees, but many hospitalizations were available from only one source. MedPAR hospital records may be missing for veterans or observation stays. Maintaining study participation increases stay completeness, but new sources such as electronic health records may be more efficient than surveillance for mobile elderly populations.

Cost-effectiveness analysis of neurocognitive-sparing treatments for brain metastases.

BACKGROUND: Decisions regarding how to treat patients who have 1 to 3 brain metastases require important tradeoffs between controlling recurrences, side effects, and costs. In this analysis, the authors compared novel treatments versus usual care to determine the incremental cost-effectiveness ratio from a payer's (Medicare) perspective. METHODS: Cost-effectiveness was evaluated using a microsimulation of a Markov model for 60 one-month cycles. The model used 4 simulated cohorts of patients aged 65 years with 1 to 3 brain metastases. The 4 cohorts had a median survival of 3, 6, 12, and 24 months to test the sensitivity of the model to different prognoses. The treatment alternatives evaluated included stereotactic radiosurgery (SRS) with 3 variants of salvage after recurrence (whole-brain radiotherapy [WBRT], hippocampal avoidance WBRT [HA-WBRT], SRS plus WBRT, and SRS plus HA-WBRT). The findings were tested for robustness using probabilistic and deterministic sensitivity analyses. RESULTS: Traditional radiation therapies remained cost-effective for patients in the 3-month and 6-month cohorts. In the cohorts with longer median survival, HA-WBRT and SRS plus HA-WBRT became cost-effective relative to traditional treatments. When the treatments that involved HA-WBRT were excluded, either SRS alone or SRS plus WBRT was cost-effective relative to WBRT alone. The deterministic and probabilistic sensitivity analyses confirmed the robustness of these results. CONCLUSIONS: HA-WBRT and SRS plus HA-WBRT were cost-effective for 2 of the 4 cohorts, demonstrating the value of controlling late brain toxicity with this novel therapy. Cost-effectiveness depended on patient life expectancy. SRS was cost-effective in the cohorts with short prognoses (3 and 6 months), whereas HA-WBRT and SRS plus HA-WBRT were cost-effective in the cohorts with longer prognoses (12 and 24 months).

Evaluation of the Predictive Value of Routinely Collected Health-Related Social Needs Measures.

The objective was to assess the value of routinely collected patient-reported health-related social needs (HRSNs) measures for predicting utilization and health outcomes. The authors identified Mayo Clinic patients with cancer, diabetes, or heart failure. The HRSN measures were collected as part of patient-reported screenings from June to December 2019 and outcomes (hospitalization, 30-day readmission, and death) were ascertained in 2020. For each outcome and disease combination, 4 models were used: gradient boosting machine (GBM), random forest (RF), generalized linear model (GLM), and elastic net (EN). Other predictors included clinical factors, demographics, and area-based HRSN measures-area deprivation index (ADI) and rurality. Predictive performance for models was evaluated with and without the routinely collected HRSN measures as change in area under the curve (AUC). Variable importance was also assessed. The differences in AUC were mixed. Significant improvements existed in 3 models of death for cancer (GBM: 0.0421, RF: 0.0496, EN: 0.0428), 3 models of hospitalization (GBM: 0.0372, RF: 0.0640, EN: 0.0441), and 1 of death (RF: 0.0754) for diabetes, and 1 model of readmissions (GBM: 0.1817), and 3 models of death (GBM: 0.0333, RF: 0.0519, GLM: 0.0489) for heart failure. Age, ADI, and the Charlson comorbidity index were the top 3 in variable importance and were consistently more important than routinely collected HRSN measures. The addition of routinely collected HRSN measures resulted in mixed improvement in the predictive performance of the models. These findings suggest that existing factors and the ADI are more important for prediction in these contexts. More work is needed to identify predictors that consistently improve model performance.

Race-ethnicity and sex differences in 1-year survival following percutaneous coronary intervention among Medicare fee-for-service beneficiaries.

RATIONALE: Existing literature describing differences in survival following percutaneous coronary intervention (PCI) by patient sex, race-ethnicity and the role of socioeconomic characteristics (SEC) is limited. AIMS AND OBJECTIVES: Evaluate differences in 1-year survival after PCI by sex and race-ethnicity, and explore the contribution of SEC to observed differences. METHODS: Using a 20% sample of Medicare claims data for beneficiaries aged 65+, we identified fee-for-service patients who received PCI from 2007 to 2015. We performed logistic regression to assess how sex and race-ethnicity relate to procedural indication, inpatient versus outpatient setting, and 1-year mortality. We evaluated whether these relationships are moderated by sequentially controlling for factors including age, comorbidities, presence of acute myocardial infarction (AMI), county SEC, medical resource availability and inpatient versus outpatient procedural status. RESULTS: We identified 300,491 PCI procedures, of which 94,863 (31.6%) were outpatient. There was a significant transition to outpatient PCI during the study period, especially for men compared with women and White patients compared with Black patients. Black patients were 3.50 percentage points (p < 0.001) and women were 3.41 percentage points (p < 0.001) more likely than White and male patients to undergo PCI at the time of AMI, which typically occurs in the inpatient setting. Controlling for age and calendar year, Black patients were 2.87 percentage points more likely than non-Hispanic White patients to die within 1 year after PCI. After controlling for Black-White differences in comorbidities, the differences in 1-year mortality decreased to 0.95 percentage points, which then became nonsignificant when further controlling for county resources and state of residence. CONCLUSION: Women were more likely to experience PCI in the setting of AMI and had less transition to outpatient care during the period. Black patients experienced higher 1-year mortality following PCI, which is explained by differences in baseline comorbidities, county medical resources, and state of residence.

Trends in the Prescribing of Buprenorphine for Opioid Use Disorder, 2019-2023.

Objective: To evaluate whether access to buprenorphine to treat opioid use disorder (OUD) was associated with the coronavirus disease pandemic, the relaxation of training requirements to obtain an X-Waiver to prescribe buprenorphine (April 2021), and the removal of the X-Waiver (December 2022). Patients and Methods: The OptumLabs Data Warehouse, which includes claims from Commercial and Medicare Advantage enrollees, was used to evaluate trends in prescription fills from January 1, 2019, to June 30, 2023. We compared fill patterns of buprenorphine for OUD with acamprosate to treat alcohol use disorder and naltrexone to treat alcohol use disorder or OUD. We evaluated trends in the rate ratio (RR) of overall fills; RR by days supply; distribution of fills by daily dose; and distribution of fills by prescriber type. Results: Coronavirus disease (RR, 1.06; 95% CI, 1.01-1.11) was associated with a slightly increased rate of fills for Commercial enrollees but not overall or for Medicare Advantage enrollees. There were also no significant increases (P>0.05) associated with the change in training requirements or removal of the X-Waiver. Over the study period, there was an increasing share of fills for 16+ mg for Commercial enrollees, and buprenorphine prescribers were more likely to be advanced practice nurses or physician assistants. Conclusion: We did not find meaningful improvement in access in response to coronavirus disease or the changes in the X-Waiver. These findings suggest that interventions beyond removing the X-Waiver may be needed to improve buprenorphine access.

Delays in bipolar depression treatment in primary care vs. integrated behavioral health and specialty care.

INTRODUCTION: While bipolar disorder is not uncommon in primary care, collaborative care models for bipolar depression treatment are underdeveloped. Our aim was to compare initial pharmacological treatment patterns for an episode of bipolar depression in different care models, namely primary care (PC), integrated behavioral health (IBH), and mood specialty clinic (SC). METHODS: A retrospective study of adults diagnosed with bipolar disorder who received outpatient care in 2020 was completed. Depressive episodes were captured based on DSM-5 criteria, ICD codes, or de novo emergent symptom burden (PHQ-9 ≥ 10). Pharmacological strategies were classified as 1) continuation of current regimen, 2) dose increase or 3) augmentation 4) switch to monotherapy or 5) a combination of more than two different strategies. Logistic regression was applied. RESULTS: A total of 217 encounters (PC = 32, IBH = 53, SC = 132) representing 186 unique patients were identified. PC was significantly more likely to continue the current regimen, while combination strategies were significantly more likely recommended in IBH and SC. Mood stabilizers were significantly more utilized in IBH and SC. There were no significant group differences in antidepressant use. LIMITATIONS: Retrospective study design at a single site. CONCLUSIONS: This study provides evidence of delays in depression care in bipolar disorder. This is the first study to compare treatment recommendations for bipolar depression in different clinical settings. Future studies are encouraged to better understand this gap and to guide future clinical practice, regardless of care model, emphasizing the potential benefits of decision support tools and collaborative care models tailored for bipolar depression.

Sudden Cardiac Death or Ventricular Arrythmia in Patients Taking Levetiracetam or Oxcarbazepine.

BACKGROUND AND OBJECTIVES: Levetiracetam is a widely used antiseizure medication. Recent concerns have been raised regarding the potential prolongation of the QT interval by levetiracetam and increased risk of sudden cardiac death. This could have profound implications for patient safety and for prescribing practice. This study assessed the potential association of levetiracetam with cardiac outcomes related to QT interval prolongation. We compared outcomes of patients taking levetiracetam with those taking oxcarbazepine as a comparator medication that has not been associated with prolongation of the QT interval. METHODS: The sample included patients who were newly prescribed levetiracetam or oxcarbazepine from January 31, 2010, to December 31, 2019, using administrative claims data from the OptumLabs Data Warehouse (OLDW). The analysis focused on a combined endpoint of sudden cardiac death or ventricular arrythmia, which are both linked to QT interval prolongation. We used a new user design and selected oxcarbazepine as an active comparator with levetiracetam to minimize bias. We used propensity score weighting to balance the levetiracetam and oxcarbazepine cohorts and then performed weighted Cox regressions to evaluate the association of levetiracetam with the combined endpoint. RESULTS: We identified 104,655 enrollees taking levetiracetam and 39,596 enrollees taking oxcarbazepine. At baseline, enrollees taking levetiracetam were older, more likely to have diagnosed epilepsy, and more likely to have diagnosed comorbidities including hypertension, cerebrovascular disease, and coronary artery disease. In the main analysis, we found no significant difference between levetiracetam and oxcarbazepine in the rate of the combined endpoint for the Cox proportional hazards model (hazard ratio [HR] 0.79, 95% CI 0.42-1.47) or Cox regression with time-varying characteristics (HR 0.78, 95% CI 0.41-1.50). DISCUSSION: When compared with oxcarbazepine, levetiracetam does not correlate with increased risk of ventricular arrythmia and sudden cardiac death. Our finding does not support the concern for cardiac risk to indicate restriction of levetiracetam use nor the requirement of cardiac monitoring when using it. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that sudden cardiac death and ventricular arrythmia are not more frequent in patients older than 17 years newly prescribed levetiracetam, compared with those prescribed oxcarbazepine.

Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story.

BACKGROUND: Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials. METHODS: We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other. RESULTS: We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism. CONCLUSIONS: From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.

Overcoming challenges in real-world evidence generation: An example from an Adult Medical Care Coordination program.

The Adult Medical Care Coordination program ("the program") was implemented at Mayo Clinic to promote patient self-management and improve 30-day unplanned readmission for patients with high risk for readmission after hospital discharge. This study aimed to evaluate the impact of the program compared to usual care using a pragmatic, stepped wedge cluster randomized trial ("stepped wedge trial"). However, several challenges arose including large differences between the study arms. Our goal is to describe the challenges and present lessons learned on how to overcome such challenges and generate evidence to support practice decisions. We describe the challenges encountered during the trial, the approach to addressing these challenges, and lessons learned for other learning health system researchers facing similar challenges. The trial experienced several challenges in implementation including several clinics dropping from the study and care disruptions due to COVID-19. Additionally, there were large differences in the patient population between the program and usual care arms. For example, the mean age was 76.8 for the program and 68.1 for usual care. Due to these differences, we adapted the methods using the propensity score matching approach that is traditionally applied to observational designs and adjusted for differences in observable characteristics. When conducting pragmatic research, researchers will encounter factors beyond their control that may introduce bias. The lessons learned include the need to weigh the tradeoffs of pragmatic design elements and the potential value of adaptive designs for pragmatic trials. Applying these lessons would promote the successful generation of evidence that informs practice decisions.

Association between early childhood sleep difficulties and subsequent psychiatric illness.

STUDY OBJECTIVES: Chronic disruptions to sleep in childhood are associated with increased prevalence of psychiatric disease later in development. When sleep disruptions remit before adolescence, the increased prevalence of psychiatric disease is no longer observed, highlighting the importance of early detection and intervention. Clinicians typically rely on caregivers' reports for diagnosis and management of childhood sleep challenges. We examined whether findings on polysomnogram (PSG) can offer similar insight into childhood sleep difficulties and the risk of subsequent psychiatric illness. METHODS: A cohort was identified of 348 children ages 5 years 11 months and younger with sleep difficulties rising to the level of formal clinical workup. A retrospective review of caregiver-reported sleep concerns, PSG results, and subsequent psychiatric illness was completed. PSG findings were compared to presence of psychiatric illness later in life as well as caregivers' reported concerns. Chi-squared and Fisher's exact tests were completed to evaluate correlations and Cohen's kappa was used to evaluate agreement. RESULTS: With only a few exceptions, comparisons between clinician findings on PSG and subsequent psychiatric diagnoses were statistically nonsignificant. Similarly, the relationship between caregivers' subjective reports about sleep and clinicians' findings on PSG demonstrated only slight to fair agreement, suggesting reported concerns were not predictive of PSG results. CONCLUSIONS: Parental reports of subjective sleep concerns are indicative of different sleep pathologies compared to sleep pathologies detected on PSG. The addition of PSG to caregiver-reported data appears to have limited clinical utility in understanding sleep concerns associated with the risk of subsequent psychiatric illness in young children. CITATION: Pease E, Shekunov J, Savitz ST, et al. Association between early childhood sleep difficulties and subsequent psychiatric illness. J Clin Sleep Med. 2023;19(12):2059-2063.

Evaluation of safety and care outcomes after the introduction of a virtual registered nurse model.

OBJECTIVE: To evaluate the impact of a virtual registered nurse (ViRN) model on safety and care outcomes. ViRN is a telemedicine intervention that enables an experienced virtual nurse to assist the in-person care team in providing care to patients. DATA SOURCES AND STUDY SETTING: Electronic health records data were utilized from the Mayo Clinic during the intervention (December 2020-November 2021) and historical periods (December 2018-November 2019). ViRN was implemented on general medical units at the Mayo Clinic Rochester. We used general medical units at the Mayo Clinic Arizona as the comparison group. STUDY DESIGN: This study used a difference-in-differences design to evaluate the impact of ViRN compared to usual care on transfer to the intensive care unit (ICU), inpatient mortality, and length of stay (LOS). We used logistic regression for transfer to the ICU and inpatient mortality and negative binomial regression for LOS. We controlled for demographics, patient interaction with the health system, clinical characteristics, and admission characteristics. We clustered standard errors to account for patients who have multiple admissions during the study period. PRINCIPAL FINDINGS: There were no significant differences for transfer to the ICU (average marginal effect (AME) -0.08 percentage point [95% confidence interval (CI): -1.34, 1.18]), inpatient mortality (AME 0.43 percentage point [95% CI: -0.33, 1.18]), or LOS (AME -0.20 days [95% CI: -0.57, 0.17]). The findings were mostly consistent across the sensitivity analyses. CONCLUSIONS: Our results suggest that ViRN led to similar outcomes as usual care in general medical units. These findings support the potential to develop more advanced models of ViRN at the Mayo Clinic and the dissemination of the ViRN model to other systems. In the context of staffing shortages and other disruptions to the delivery of nursing care, it is critical to understand whether new models like ViRN provide nurse staffing alternatives without negatively affecting outcomes.

Co-Occurrence of Social Risk Factors and Associated Outcomes in Patients With Heart Failure.

Background Among patients with heart failure (HF), social risk factors (SRFs) are associated with poor outcomes. However, less is known about how co-occurrence of SRFs affect all-cause health care utilization for patients with HF. The objective was to address this gap using a novel approach to classify co-occurrence of SRFs. Methods and Results This was a cohort study of residents living in an 11-county region of southeast Minnesota, aged ≥18 years with a first-ever diagnosis for HF between January 2013 and June 2017. SRFs, including education, health literacy, social isolation, and race and ethnicity, were obtained via surveys. Area-deprivation index and rural-urban commuting area codes were determined from patient addresses. Associations between SRFs and outcomes (emergency department visits and hospitalizations) were assessed using Andersen-Gill models. Latent class analysis was used to identify subgroups of SRFs; associations with outcomes were examined. A total of 3142 patients with HF (mean age, 73.4 years; 45% women) had SRF data available. The SRFs with the strongest association with hospitalizations were education, social isolation, and area-deprivation index. We identified 4 groups using latent class analysis, with group 3, characterized by more SRFs, at increased risk of emergency department visits (hazard ratio [HR], 1.33 [95% CI, 1.23-1.45]) and hospitalizations (HR, 1.42 [95% CI, 1.28-1.58]). Conclusions Low educational attainment, high social isolation, and high area-deprivation index had the strongest associations. We identified meaningful subgroups with respect to SRFs, and these subgroups were associated with outcomes. These findings suggest that it is possible to apply latent class analysis to better understand the co-occurrence of SRFs among patients with HF.

National trends in emergency conditions through the Omicron COVID-19 wave in commercial and Medicare Advantage enrollees.

Objective: To evaluate trends in emergency care sensitive conditions (ECSCs) from pre-COVID (March 2018-February 2020) through Omicron (December 2021-February 2022). Methods: This cross-sectional analysis evaluated trends in ECSCs using claims (OptumLabs Data Warehouse) from commercial and Medicare Advantage enrollees. Emergency department (ED) visits for ECSCs (acute appendicitis, aortic aneurysm/dissection, cardiac arrest/severe arrhythmia, cerebral infarction, myocardial infarction, pulmonary embolism, opioid overdose, pre-eclampsia) were reported per 100,000 person months from March 2018 to February 2022 by pandemic wave. We calculated the percent change for each pandemic wave compared to the pre-pandemic period. Results: There were 10,268,554 ED visits (March 2018-February 2022). The greatest increases in ECSCs were seen for pulmonary embolism, cardiac arrest/severe arrhythmia, myocardial infarction, and pre-eclampsia. For commercial enrollees, pulmonary embolism visit rates increased 22.7% (95% confidence interval [CI], 18.6%-26.9%) during Waves 2-3, 37.2% (95% CI, 29.1%-45.8%] during Delta, and 27.9% (95% CI, 20.3%-36.1%) during Omicron, relative to pre-pandemic rates. Cardiac arrest/severe arrhythmia visit rates increased 4.0% (95% CI, 0.2%-8.0%) during Waves 2-3; myocardial infarction rates increased 4.9% (95% CI, 2.1%-7.8%) during Waves 2-3. Similar patterns were seen in Medicare Advantage enrollees. Pre-eclampsia visit rates among reproductive-age female enrollees increased 31.1% (95% CI, 20.9%-42.2%), 23.7% (95% CI, 7.5%,-42.3%), and 34.7% (95% CI, 16.8%-55.2%) during Waves 2-3, Delta, and Omicron, respectively. ED visits for other ECSCs declined or exhibited smaller increases. Conclusions: ED visit rates for acute cardiovascular conditions, pulmonary embolism and pre-eclampsia increased despite declines or stable rates for all-cause ED visits and ED visits for other conditions. Given the changing landscape of ECSCs, studies should identify drivers for these changes and interventions to mitigate them.

Advanced Heart Failure Characteristics and Outcomes in Commercially Insured U.S. Adults.

BACKGROUND: The characteristics and outcomes of patients with advanced heart failure (HF) have been poorly defined due to challenges in applying the complex advanced HF definition broadly to populations. OBJECTIVES: In this study, the authors sought to apply a validated advanced HF algorithm to a large U.S. administrative claims database and describe the population and use of advanced HF therapies. METHODS: This study included adults with advanced HF identified in the OptumLabs Data Warehouse from 2009 to 2019. The algorithm for advanced HF required 2 hospitalizations for HF plus 1 additional sign of advanced HF in a 12-month period. The association of baseline characteristics with mortality was examined with the use of Cox proportional hazards models. Associations of patient characteristics with advanced therapies were estimated with the use of cause-specific Cox proportional hazard models. RESULTS: In 60,197 patients identified with advanced HF, the mean age was 73 years, 51.5% were men, and 64.3% were non-Hispanic White, 1.9% Asian, 21.2% Black, and 8.2% Hispanic. The median survival with advanced HF was 2.0 years (IQR: 0.4-5.5 years). Differences in mortality and use of advanced therapies by age, sex, and race/ethnicity were observed. Adjusted mortality was higher in patients who were older, male, non-Hispanic White, and from rural areas (P < 0.05 for all). Advanced therapies were used less in older patients and women (P < 0.05 for both). Black patients were more likely to be treated with a left ventricular assist device (P = 0.010) but less likely to receive a heart transplant compared with White patients (P = 0.034). CONCLUSIONS: In U.S. adults with advanced HF, variation in outcomes and use of advanced therapies exist by age, sex, and race/ethnicity.

Identifying appropriate comparison groups for health system interventions in the COVID-19 era.

Introduction: COVID-19 has created additional challenges for the analysis of non-randomized interventions in health system settings. Our objective is to evaluate these challenges and identify lessons learned from the analysis of a medically tailored meals (MTM) intervention at Kaiser Permanente Northwest (KPNW) that began in April 2020. Methods: We identified both a historical and concurrent comparison group. The historical comparison group included patients living in the same area as the MTM recipients prior to COVID-19. The concurrent comparison group included patients admitted to contracted non-KPNW hospitals or admitted to a KPNW facility and living outside the service area for the intervention but otherwise eligible. We used two alternative propensity score methods in response to the loss of sample size with exact matching to evaluate the intervention. Results: We identified 452 patients who received the intervention, 3873 patients in the historical comparison group, and 5333 in the concurrent comparison group. We were able to mostly achieve balance on observable characteristics for the intervention and the two comparison groups. Conclusions: Lessons learned included: (a) The use of two different comparison groups helped to triangulate results; (b) the meaning of utilization measures changed pre- and post-COVID-19; and (c) that balance on observable characteristics can be achieved, especially when the comparison groups are meaningfully larger than the intervention group. These findings may inform the design for future evaluations of interventions during COVID-19.