Faculty Bibliography

BACKGROUND/UNASSIGNED:Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study evaluates the feasibility of a randomized clinical trial (RCT) testing the efficacy of integrated kidney palliative and CKD care in an urban safety-net hospital. METHODS/UNASSIGNED:, and are receiving care at our safety net hospital. Participants will be randomized in permuted blocks of two or four to either the intervention group, who will receive monthly ambulatory care visits for six months with a palliative care provider trained in kidney palliative care, or to usual nephrology care. Primary outcomes are feasibility of recruitment, retention, fidelity to the study visit protocol, and the ability to collect outcome data. These outcomes include symptom burden, quality of life, and engagement in advance care planning. DISCUSSION/UNASSIGNED:This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will inform a larger, fully powered trial that tests the efficacy of our kidney palliative care approach. CLINICAL TRIAL REGISTRATION/UNASSIGNED:NCT04998110.

BACKGROUND:Drug overdose deaths have increased fivefold over the last 20 years, primarily fueled by synthetic opioids, which led the Centers for Disease Control and Prevention to declare an opioid overdose epidemic. Responding to this epidemic, we designed and implemented opioid overdose prevention (OOP) training for medical students to help promote effective naloxone usage. Previously, we compared online and in-person versions of OOP training over 2 years of training. To better establish the evidence for online training, we performed a randomized controlled non-inferiority trial comparing in-person with online opioid prevention training. METHODS:Third-year medical students were randomized into groups to receive either in-person or online training in preparation for clinical rotations. Students randomized to receive online training were provided a link to the training modules. Students randomized to receive in-person training were trained in an in-person setting. We performed a non-inferiority per-protocol analysis with the primary outcome of knowledge using a non-inferiority margin of a -9.1% difference between groups. RESULTS:A total of 205 students were randomized, 103 students to in-person training and 102 to online training. Eighty-three in-person students and 104 online students were included. The online group had a higher post-training knowledge score compared to the in-person group by 0.44 points (0-11 point scale) with a 95% CI of (-0.04, 0.93) that did not cross the margin of non-inferiority. CONCLUSIONS:Online training for OOP was effective and non-inferior to in-person training. Online OOP training may be considered an alternative to in-person training.

BACKGROUND:The linear mixed-effects model (LME) is a conventional parametric method mainly used for analyzing longitudinal and clustered data in genetic studies. Previous studies have shown that this model can be sensitive to parametric assumptions and provides less predictive performance than non-parametric methods such as random effects-expectation maximization (RE-EM) and unbiased RE-EM regression tree algorithms. These longitudinal regression trees utilize classification and regression trees (CART) and conditional inference trees (Ctree) to estimate the fixed-effects components of the mixed-effects model. While CART is a well-known tree algorithm, it suffers from greediness. To mitigate this issue, we used the Evtree algorithm to estimate the fixed-effects part of the LME for handling longitudinal and clustered data in genome association studies. METHODS:In this study, we propose a new non-parametric longitudinal-based algorithm called "Ev-RE-EM" for modeling a continuous response variable using the Evtree algorithm to estimate the fixed-effects part of the LME. We compared its predictive performance with other tree algorithms, such as RE-EM and unbiased RE-EM, with and without considering the structure for autocorrelation between errors within subjects to analyze the longitudinal data in the genetic study. The autocorrelation structures include a first-order autoregressive process, a compound symmetric structure with a constant correlation, and a general correlation matrix. The real data was obtained from the longitudinal Tehran cardiometabolic genetic study (TCGS). The data modeling used body mass index (BMI) as the phenotype and included predictor variables such as age, sex, and 25,640 single nucleotide polymorphisms (SNPs). RESULTS:The results demonstrated that the predictive performance of Ev-RE-EM and unbiased RE-EM was nearly similar. Additionally, the Ev-RE-EM algorithm generated smaller trees than the unbiased RE-EM algorithm, enhancing tree interpretability. CONCLUSION/CONCLUSIONS:The results showed that the unbiased RE-EM and Ev-RE-EM algorithms outperformed the RE-EM algorithm. Since algorithm performance varies across datasets, researchers should test different algorithms on the dataset of interest and select the best-performing one. Accurately predicting and diagnosing an individual's genetic profile is crucial in medical studies. The model with the highest accuracy should be used to enhance understanding of the genetics of complex traits, improve disease prevention and diagnosis, and aid in treating complex human diseases.

BACKGROUND:Loneliness is a quality-of-life (QoL) concern for patients facing serious, life-limiting illnesses. Discerning risk factors of loneliness in palliative care patients allows providers to take preventative action and develop holistic treatment plans. METHODS:A planned sub-study of patients who completed the previously developed Three-Item Loneliness Scale upon enrollment into the multicenter, randomized clinical trial Emergency Medicine Palliative Care Access (EMPallA) with the objective of investigating the association of multimorbidity with loneliness in patients with late-stage illnesses. The EMPallA study included patients who were at least 50 years old and diagnosed with at least one end-stage illness (advanced cancer, advanced congestive heart failure (CHF), end-stage renal disease (ESRD), or advanced chronic obstructive pulmonary disease (COPD)). RESULTS:We analyzed 1,212 surveys using a mixed-effects logistic regression model. Our findings suggest those with a single illness are less likely to be lonely than those with multimorbidity (odds ratio [OR] = 0.5, 95% CI 0.3 to 0.8). Additionally, older age was associated with less loneliness (OR comparing age by 10-year increments is 0.7 [95% CI: 0.6 to 0.9]), after adjusting for disease type, education level, race, sex, immigrant status, having a caregiver, COVID-19 period, language, and site geographic location. CONCLUSIONS:Patients suffering from multimorbidity self-report being "very lonely" more often than patients with a single advanced illness; furthermore, advanced illness patients who were middle-aged (versus elderly) were 25% more likely to report being "very lonely." TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov identifier: NCT03325985. Registered October 30, 2017.

IMPORTANCE/UNASSIGNED:The emergency department (ED) offers an opportunity to initiate palliative care for older adults with serious, life-limiting illness. OBJECTIVE/UNASSIGNED:To assess the effect of a multicomponent intervention to initiate palliative care in the ED on hospital admission, subsequent health care use, and survival in older adults with serious, life-limiting illness. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Cluster randomized, stepped-wedge, clinical trial including patients aged 66 years or older who visited 1 of 29 EDs across the US between May 1, 2018, and December 31, 2022, had 12 months of prior Medicare enrollment, and a Gagne comorbidity score greater than 6, representing a risk of short-term mortality greater than 30%. Nursing home patients were excluded. INTERVENTION/UNASSIGNED:A multicomponent intervention (the Primary Palliative Care for Emergency Medicine intervention) included (1) evidence-based multidisciplinary education; (2) simulation-based workshops on serious illness communication; (3) clinical decision support; and (4) audit and feedback for ED clinical staff. MAIN OUTCOME AND MEASURES/UNASSIGNED:The primary outcome was hospital admission. The secondary outcomes included subsequent health care use and survival at 6 months. RESULTS/UNASSIGNED:There were 98 922 initial ED visits during the study period (median age, 77 years [IQR, 71-84 years]; 50% were female; 13% were Black and 78% were White; and the median Gagne comorbidity score was 8 [IQR, 7-10]). The rate of hospital admission was 64.4% during the preintervention period vs 61.3% during the postintervention period (absolute difference, -3.1% [95% CI, -3.7% to -2.5%]; adjusted odds ratio [OR], 1.03 [95% CI, 0.93 to 1.14]). There was no difference in the secondary outcomes before vs after the intervention. The rate of admission to an intensive care unit was 7.8% during the preintervention period vs 6.7% during the postintervention period (adjusted OR, 0.98 [95% CI, 0.83 to 1.15]). The rate of at least 1 revisit to the ED was 34.2% during the preintervention period vs 32.2% during the postintervention period (adjusted OR, 1.00 [95% CI, 0.91 to 1.09]). The rate of hospice use was 17.7% during the preintervention period vs 17.2% during the postintervention period (adjusted OR, 1.04 [95% CI, 0.93 to 1.16]). The rate of home health use was 42.0% during the preintervention period vs 38.1% during the postintervention period (adjusted OR, 1.01 [95% CI, 0.92 to 1.10]). The rate of at least 1 hospital readmission was 41.0% during the preintervention period vs 36.6% during the postintervention period (adjusted OR, 1.01 [95% CI, 0.92 to 1.10]). The rate of death was 28.1% during the preintervention period vs 28.7% during the postintervention period (adjusted OR, 1.07 [95% CI, 0.98 to 1.18]). CONCLUSIONS AND RELEVANCE/UNASSIGNED:This multicomponent intervention to initiate palliative care in the ED did not have an effect on hospital admission, subsequent health care use, or short-term mortality in older adults with serious, life-limiting illness. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03424109.

BACKGROUND:Understanding how prognosis influences acute care use among older adults at risk of short-term mortality is essential for providing care consistent with patients' wishes. This study assesses whether prognosis is associated with acute care and Intensive Care Unit (ICU) transfer in older adults presenting to the Emergency Department (ED) at high and low risk of short-term mortality. METHODS:For this cross-sectional analysis, we pooled the Medicare claims for older adults 66 years and older from 2015 to 2019 who visited at least one of the 29 EDs participating in the Primary Palliative Care for Emergency Medicine study. Our outcome measures were defined as an acute care admission and ICU transfer resulting from an ED visit, both measured as binary variables. The predictor variables were age, sex, race/ethnicity, and Gagne score. We stratified the analysis into those with low (≤6) and high risk (>6) short-term mortality using the Gagne scores. To assess the odds of an acute care or ICU transfer, we used multivariable logistic regression via generalized estimating equation models and computed the adjusted odds ratios (AOR) among the general population and among those at high risk of short-term mortality. RESULTS:Of the 301,083 older adults who visited one of the 29 EDs, 13% were at high risk for short-term mortality. Among this high-risk group, 64% had an acute care admission, and 15% of those admitted had an ICU transfer, as compared to 43% and 12% of those at low risk of short-term mortality. Among those at high risk for short-term mortality, prognosis was associated with 6% (AOR 1.06; 95% CI: 1.04 - 1.09) and 8% (AOR 1.08; 95% CI: 1.06 - 1.09) increased adjusted odds of inpatient admission and ICU transfer, respectively. CONCLUSION/CONCLUSIONS:The prognosis of older adults, especially those at high risk of short-term mortality, predicts both inpatient admissions and ICU transfers.

BACKGROUND:The optimal management of patients with intermediate-risk pulmonary embolism (PE), who have right heart dysfunction (determined by a combination of imaging and cardiac biomarkers) but a normal blood pressure, is uncertain. These patients suffer from reduced functional capacity and a lower quality of life over the long-term, despite use of anticoagulant therapy. Catheter-directed therapy (CDT) is a promising treatment for acute PE that rapidly removes thrombus and potentially improves cardiac dysfunction. However, CDT has risk and is costly, and it is not known whether it improves long-term cardiorespiratory fitness and/or quality of life compared with anticoagulation alone. METHODS:) with cardiopulmonary exercise testing at 3 months and reduce New York Heart Association (NYHA) Class at 12 months compared with No-CDT. These 2 primary efficacy outcomes will be analyzed sequentially using a "gatekeeping" procedure; for NYHA class to be compared, peak oxygen consumption must first be shown to be significantly increased by CDT. Safety and cost-effectiveness will also be assessed. CONCLUSION/CONCLUSIONS:When completed, PE-TRACT will provide important evidence regarding the benefits and risks of CDT to treat intermediate-risk PE compared with anticoagulation alone. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov: NCT05591118.

CONTEXT/BACKGROUND:Outpatient Palliative Care (OPC) benefits persons living with serious illness, yet barriers exist in utilization. OBJECTIVES/OBJECTIVE:To identify factors associated with OPC clinic utilization. METHODS:Emergency Medicine Palliative Care Access is a multicenter, randomized control trial comparing two models of palliative care for patients recruited from the Emergency Department (ED): nurse-led telephonic case management and OPC (one visit a month for 6 months). Patients were aged 50+ with advanced cancer or end-stage organ failure and recruited from 19 EDs. Using a mixed effects hurdle model, we analyzed patient, provider, clinic and healthcare system factors associated with OPC utilization. RESULTS:Among the 603 patients randomized to OPC, about half (53.6%) of patients attended at least one clinic visit. Those with less than high school education were less likely to attend an initial visit than those with a college degree or higher (aOR 0.44; CI 0.23, 0.85), as were patients who required considerable assistance (aOR 0.45; CI 0.25, 0.82) or had congestive heart failure only (aOR 0.46; CI 0.26, 0.81). Those with higher symptom burden had a higher attendance at the initial visit (aOR 1.05; CI 1.00, 1.10). Reduced follow up visit rates were demonstrated for those of older age (aRR 0.90; CI 0.82, 0.98), female sex (aRR 0.84; CI 0.71, 0.99), and those that were never married (aRR 0.62; CI 0.52, 0.87). CONCLUSION/CONCLUSIONS:Efforts to improve OPC utilization should focus on those with lower education, more functional limitations, older age, female sex, and those with less social support. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER/UNASSIGNED:NCT03325985.

BACKGROUND:Precision medicine has led to the development of targeted treatment strategies tailored to individual patients based on their characteristics and disease manifestations. Although precision medicine often focuses on a single health outcome for individualized treatment decision rules (ITRs), relying only on a single outcome rather than all available outcomes information leads to suboptimal data usage when developing optimal ITRs. METHODS:To address this limitation, we propose a Bayesian multivariate hierarchical model that leverages the wealth of correlated health outcomes collected in clinical trials. The approach jointly models mixed types of correlated outcomes, facilitating the "borrowing of information" across the multivariate outcomes, and results in a more accurate estimation of heterogeneous treatment effects compared to using single regression models for each outcome. We develop a treatment benefit index, which quantifies the relative benefit of the experimental treatment over the control treatment, based on the proposed multivariate outcome model. RESULTS:We demonstrate the strengths of the proposed approach through extensive simulations and an application to an international Coronavirus Disease 2019 (COVID-19) treatment trial. Simulation results indicate that the proposed method reduces the occurrence of erroneous treatment decisions compared to a single regression model for a single health outcome. Additionally, the sensitivity analyses demonstrate the robustness of the model across various study scenarios. Application of the method to the COVID-19 trial exhibits improvements in estimating the individual-level treatment efficacy (indicated by narrower credible intervals for odds ratios) and optimal ITRs. CONCLUSION/CONCLUSIONS:The study jointly models mixed types of outcomes in the context of developing ITRs. By considering multiple health outcomes, the proposed approach can advance the development of more effective and reliable personalized treatment.

BACKGROUND:Offering medications for opioid use disorder (MOUD) in carceral settings significantly reduces overdose. However, it is unknown to what extent individuals in jails continue MOUD once they leave incarceration. We aimed to assess the relationship between in-jail MOUD and MOUD continuity in the month following release. METHODS:We conducted a retrospective cohort study of linked NYC jail-based electronic health records and community Medicaid OUD treatment claims for individuals with OUD discharged from jail between 2011 and 2017. We compared receipt of MOUD within 30 days of release, among those with and without MOUD at release from jail. We tested for effect modification based on MOUD receipt prior to incarceration and assessed factors associated with treatment discontinuation. RESULTS:Of 28,298 eligible incarcerations, 52.8 % received MOUD at release. 30 % of incarcerations with MOUD at release received community-based MOUD within 30 days, compared to 7 % of incarcerations without MOUD (Risk Ratio: 2.62 (2.44-2.82)). Most (69 %) with MOUD claims prior to incarceration who received in-jail MOUD continued treatment in the community, compared to 9 % of those without prior MOUD. Those who received methadone (vs. buprenorphine), were younger, Non-Hispanic Black and with no history of MOUD were less likely to continue MOUD following release. CONCLUSIONS:MOUD maintenance in jail is strongly associated with MOUD continuity upon release. Still, findings highlight a gap in treatment continuity upon-reentry, especially among those who initiate MOUD in jail. In the wake of worsening overdose deaths and troubling disparities, improving MOUD continuity among this population remains an urgent priority.