Faculty Bibliography

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.

Depression is associated with adverse outcomes in epilepsy but is undertreated in this population. Project UPLIFT, a telephone-based depression self-management program, was developed for adults with epilepsy and has been shown to reduce depressive symptoms in English-speaking patients. There remains an unmet need for accessible mental health programs for Hispanic adults with epilepsy. The purpose of this study was to evaluate the feasibility, acceptability, and effects on depressive symptoms of a culturally adapted version of UPLIFT for the Hispanic community. Hispanic patients with elevated depressive symptoms (n = 72) were enrolled from epilepsy clinics in New York City and randomized to UPLIFT or usual care. UPLIFT was delivered in English or Spanish to small groups in eight weekly telephone sessions. Feasibility was assessed by recruitment, retention, and adherence rates and acceptability was assessed by self-reported satisfaction with the intervention. Depressive symptoms (PHQ-9 scores) were compared between study arms over 12 months. The mean age was 43.3±11.3, 71% of participants were female and 67% were primary Spanish speakers. Recruitment (76% consent rate) and retention rates (86-93%) were high. UPLIFT participants completed a median of six out of eight sessions and satisfaction ratings were high, but rates of long-term practice were low. Rates of clinically significant depressive symptoms (PHQ-9 ≥5) were lower in UPLIFT versus usual care throughout follow-up (63% vs. 72%, 8 weeks; 40% vs. 70%, 6 months; 47% vs. 70%, 12 months). Multivariable-adjusted regressions demonstrated statistically significant differences at 6 months (OR = 0.24, 95% CI, 0.06-0.93), which were slightly reduced at 12 months (OR = 0.30, 95% CI, 0.08-1.16). Results suggest that UPLIFT is feasible and acceptable among Hispanic adults with epilepsy and demonstrate promising effects on depressive symptoms. Larger trials in geographically diverse samples are warranted.

BACKGROUND:The Emergency Medicine Palliative Care Access (EMPallA) trial is a large, multicenter, parallel, two-arm randomized controlled trial in emergency department (ED) patients comparing two models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. This report aims to: 1) report baseline demographic and quality of life (QOL) data for the EMPallA cohort, 2) identify the association between illness type and baseline QOL while controlling for other factors, and 3) explore baseline relationships between illness type, symptom burden, and loneliness. METHODS: < 50%) are eligible for enrollment. Baseline data includes self-reported demographics, QOL measured by the Functional Assessment of Cancer Therapy-General (FACT-G), loneliness measured by the Three-Item UCLA Loneliness Scale, and symptom burden measured by the Edmonton Revised Symptom Assessment Scale. Descriptive statistics were used to analyze demographic variables, a linear regression model measured the importance of illness type in predicting QOL, and chi-square tests of independence were used to quantify relationships between illness type, symptom burden, and loneliness. RESULTS:Between April 2018 and April 3, 2020, 500 patients were enrolled. On average, end-stage organ failure patients had lower QOL as measured by the FACT-G scale than cancer patients with an estimated difference of 9.6 points (95% CI: 5.9, 13.3), and patients with multiple conditions had a further reduction of 7.4 points (95% CI: 2.4, 12.5), when adjusting for age, education level, race, sex, immigrant status, presence of a caregiver, and hospital setting. Symptom burden and loneliness were greater in end-stage organ failure than in cancer. CONCLUSIONS:The EMPallA trial is enrolling a diverse sample of ED patients. Differences by illness type in QOL, symptom burden, and loneliness demonstrate how distinct disease trajectories manifest in the ED. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov identifier: NCT03325985 . Registered October 30, 2017.

BACKGROUND/OBJECTIVES/OBJECTIVE:Poor communication is a barrier to care for people with hearing loss. We assessed the feasibility and potential benefit of providing a simple hearing assistance device during an emergency department (ED) visit, for people who reported difficulty hearing. DESIGN/METHODS:Randomized controlled pilot study. SETTING/METHODS:The ED of New York Harbor Manhattan Veterans Administration Medical Center. PARTICIPANTS/METHODS:One hundred and thirty-three Veterans aged 60 and older, presenting to the ED, likely to be discharged to home, who either (1) said that they had difficulty hearing, or (2) scored 10 or greater (range 0-40) on the Hearing Handicap Inventory-Survey (HHI-S). INTERVENTION/METHODS:Subjects were randomized (1:1), and intervention subjects received a personal amplifier (PA; Williams Sound Pocketalker 2.0) for use during their ED visit. MEASUREMENTS/METHODS:Three survey instruments: (1) six-item Hearing and Understanding Questionnaire (HUQ); (2) three-item Care Transitions Measure; and (3) three-item Patient Understanding of Discharge Information. Post-ED visit phone calls to assess ED returns. RESULTS:Of the 133 subjects, 98.3% were male; mean age was 76.4 years (standard deviation (SD) = 9.2). Mean HHI-S score was 19.2 (SD = 8.3). Across all HUQ items, intervention subjects reported better in-ED experience than controls. Seventy-five percent of intervention subjects agreed or strongly agreed that ability to understand what was said was without effort versus 56% for controls. Seventy-five percent of intervention subjects versus 36% of controls said clinicians provided them with an explanation about presenting problems. Three percent of intervention subjects had an ED revisit within 3 days compared with 9.0% controls. CONCLUSION/CONCLUSIONS:Veterans with hearing difficulties reported improved in-ED experiences with use of PAs, and were less likely to return to the ED within 3 days. PAs may be an important adjunct to older patient ED care but require validation in a larger more definitive randomized controlled trial.

Background Older adults with Alzheimer disease (AD) have high rates of emergency department (ED) visits, hospital admissions, and revisits to the ED, which are associated with poor clinical outcomes. ED providers are in a unique role to impact the care trajectories of older adults with AD since they are at the crossroads of inpatient and ambulatory care. Few studies have used administrative data to describe care trajectories of older adults with AD from the ED perspective. Our study aims to use Medicare claims data to 1) identify and characterize older adults with AD presenting to the ED, and 2) describe their post-ED visit outcomes including ED disposition, healthcare utilization and survival in the 12 months following an index ED visit. Methods We identified older adults aged 66+ years with AD who presented to 33 EDs across the United States between January 1, 2014 and June 30, 2019 using Medicare claims by selecting patients with two AD diagnoses, at least one of which is associated with an office visit, at least 7 days apart. Descriptive statistics were used to characterize demographics and post-ED visit outcomes. Results Of the 74,543 patients meeting inclusion criteria with an index ED visit during the study period, 62.6% were male, 75.7% were white, and the mean age was 83.2 years. The majority were admitted from home with (10.3%) or without (73.2%) home health, while 16.6% were admitted from a nursing facility. More than half of the patients were admitted to the hospital (54.6%), and few were discharged to a nursing home (2.9%), hospice (0.3%), or home health (1.4%). In the 12 months following the index ED visit, 42.7% of patients had at least one ED revisit, 44.6% were later admitted to the hospital, 12.7% were admitted to hospice, and 29.2% died. Conclusions This study highlights the utility of Medicare claims data to identify older adults with AD presenting to the ED and describe their care trajectories. It confirms older adults with AD who visit the ED have high rates of inpatient admissions, ED revisits, and subsequent hospital admissions despite high one-year mortality. This data is foundational for future interventions addressing the role of emergency providers in balancing the benefits and harms of hospitalization for older adults with AD and connecting these high-utilizers with appropriate outpatient services

Background: Conservative kidney management (CKM) of kidney failure is an important treatment option for many patients. However, its availability in the United States (US) is not well described. We describe CKM resources and provider practice patterns in US Chronic Kidney Disease (CKD) clinics.
Method(s): Cross sectional analysis of provider surveys (n=22) from unique clinics in the US from the CKD Outcomes and Practice Patterns Study (CKDopps) collected between 2014-2017.
Result(s): Only eight (36%) providers reported involving palliative care in planning for and educating patients about kidney failure. A majority (59%) were extremely comfortable discussing CKM and nearly 100% typically discussed CKM as a treatment option. Nearly all (95%) reported their clinics had the ability to routinely deliver CKM, but only one had a CKM protocol or guideline, and none offered a specific CKM clinic. Most providers said their clinics used the word conservative to describe CKM, with 24% choosing palliative or supportive terminology. Regardless of involvement of PC, most providers estimated that 5% of their patients with or approaching kidney failure were managed with CKM. Patient preference, functional status, frailty, and comorbidities were the most important factors influencing provider decisions in contemplating the suitability of CKM for patients. (Figure 1)
Conclusion(s): Most providers report feeling comfortable discussing CKM, yet almost no clinics report resources or dedicated infrastructure for CKM delivery. Despite reported high frequency of discussing CKM, few patients were described as choosing this treatment pathway. Factors that influence consideration of CKM are consistent with elements that generally influence well-informed geriatric and end-of-life care. Efforts to improve assessment of those elements may allow for more informed recommendations of CKM

OBJECTIVES/OBJECTIVE:The aim of this study was to assess the performance and impact of multilevel modelling (MLM) compared with ordinary least squares (OLS) regression in trial-based economic evaluations with clustered data. METHODS:Three thousand datasets with balanced and unbalanced clusters were simulated with correlation coefficients between costs and effects of - 0.5, 0, and 0.5, and intraclass correlation coefficients (ICCs) varying between 0.05 and 0.30. Each scenario was analyzed using both MLM and OLS. Statistical uncertainty around MLM and OLS estimates was estimated using bootstrapping. Performance measures were estimated and compared between approaches, including bias, root mean squared error (RMSE) and coverage probability. Cost and effect differences, and their corresponding confidence intervals and standard errors, incremental cost-effectiveness ratios, incremental net-monetary benefits and cost-effectiveness acceptability curves were compared. RESULTS:Cost-effectiveness outcomes were similar between OLS and MLM. MLM produced larger statistical uncertainty and coverage probabilities closer to nominal levels than OLS. The higher the ICC, the larger the effect on statistical uncertainty between MLM and OLS. Significant cost-effectiveness outcomes as estimated by OLS became non-significant when estimated by MLM. At all ICCs, MLM resulted in lower probabilities of cost effectiveness than OLS, and this difference became larger with increasing ICCs. Performance measures and cost-effectiveness outcomes were similar across scenarios with varying correlation coefficients between costs and effects. CONCLUSIONS:Although OLS produced similar cost-effectiveness outcomes, it substantially underestimated the amount of variation in the data compared with MLM. To prevent suboptimal conclusions and a possible waste of scarce resources, it is important to use MLM in trial-based economic evaluations when data are clustered.

This study examined longitudinal relations between emotion knowledge (EK) in pre-kindergarten (pre-K; M_age  = 4.8 years) and math and reading achievement 1 and 3 years later in a sample of 1,050 primarily Black children (over half from immigrant families) living in historically disinvested neighborhoods. Participants were part of a follow-up study of a cluster randomized controlled trial. Controlling for pre-academic skills, other social-emotional skills, sociodemographic characteristics, and school intervention status, higher EK at the end of pre-K predicted higher math and reading achievement test scores in kindergarten and second grade. Moderation analyses suggest that relations were attenuated among children from immigrant families. Findings suggest the importance of enriching pre-K programs for children of color with EK-promotive interventions and strategies.

There is overwhelming need for nonpharmacological interventions to improve the health and well-being of people living with dementia (PLWD). The National Institute on Aging Imbedded Pragmatic Alzheimer's Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory supports clinical trials of such interventions embedded in healthcare systems. The embedded pragmatic clinical trial (ePCT) is ideally suited to testing the effectiveness of complex interventions in vulnerable populations at the point of care. These trials, however, are complex to conduct and interpret, and face challenges in efficiency (i.e., statistical power) and reproducibility. In addition, trials conducted among PLWD present specific statistical challenges, including difficulty in outcomes ascertainment from PLWD, necessitating reliance on reports by caregivers, and heterogeneity in measurements across different settings or populations. These and other challenges undercut the reliability of measurement, the feasibility of capturing outcomes using pragmatic designs, and the ability to validly estimate interventions' effectiveness in real-world settings. To address these challenges, the IMPACT Collaboratory has convened a Design and Statistics Core, the goals of which are: to support the design and conduct of ePCTs directed toward PLWD and their caregivers; to develop guidance for conducting embedded trials in this population; and to educate quantitative and clinical scientists in the design, conduct, and analysis of these trials. In this article, we discuss some of the contemporary methodological challenges in this area and develop a set of research priorities the Design and Statistics Core will undertake to meet these goals. J Am Geriatr Soc 68:S68-S73, 2020.

BACKGROUND: Alcohol and drug use are often under-identified in primary care settings. While prior research indicates that patients are generally supportive of alcohol screening, less is known about attitudes toward drug screening or the collection of this information in electronic health records (EHRs). As a part of an implementation study of EHRintegrated substance use screening in primary care, conducted in the NIDA Clinical Trials Network, patients were surveyed on their attitudes toward screening for substance use during medical visits.
METHOD(S): Surveys were administered to patients in four urban academic primary care clinics on a quarterly basis, for one year following the introduction of a screening program. English-speaking adult patients presenting for a primary care visit were eligible. Participants were recruited from the waiting room and self-administered an 18-item survey exploring attitudes toward screening and discussing substance use with healthcare providers.
RESULT(S): A total of 479 patients completed the survey (mean age 54.1; 58% female; 58% white, 23% black; 19% Hispanic/Latino). Participants overwhelmingly felt that they should be asked about their substance use (91%), and deemed it appropriate for their doctor to recommend reducing use if it could adversely affect their health (92%). Most (87%) were equally comfortable discussing alcohol or drug use. A majority (63%) preferred discussing substance use with their doctor over other medical staff. Responses weremixed regarding screening modality: 55%preferred face-to-face, 22% had no preference, 14% preferred self- administration. Participants reported that they would be honest with their provider (94%), but 32% were concerned about medical record confidentiality.
CONCLUSION(S): Primary care patients strongly supported being screened for drug and alcohol use, and would be comfortable discussing it with their doctor. However, patients' concerns about having their substance use documented in their medical record could pose a barrier to achieving accurate responses. These findings suggest a need to educate patients on the confidentiality of medical records and the value of disclosing substance use for their medical care