Faculty Bibliography

Importance/UNASSIGNED:Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities. Objective/UNASSIGNED:To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB. Design, Setting, and Participants/UNASSIGNED:This open-label, randomized comparative effectiveness study included 52 incarcerated adults in New York City observed for 8 weeks postrelease between June 2019 and May 2020. Participants were soon-to-be-released volunteers from 1 men's and 1 women's jail facility who had OUDs already treated with SLB. Follow-up treatment was received at a primary care clinic in Manhattan. Data were analyzed between June 2020 and December 2020. Interventions/UNASSIGNED:XRB treatment was offered prior to release and continued monthly through 8 weeks after release. SLB participants continued to receive daily directly observed in-jail SLB administration, were provided a 7-day SLB supply at jail release, and followed up at a designated clinic (or other preferred clinics). Main Outcomes and Measures/UNASSIGNED:Buprenorphine treatment retention at 8 weeks postrelease. Results/UNASSIGNED:A total of 52 participants were randomized 1:1 to XRB (26 participants) and SLB (26 participants). Participants had a mean (SD) age of 42.6 (10.0) years; 45 participants (87%) were men; and 40 (77%) primarily used heroin prior to incarceration. Most participants (30 [58%]) reported prior buprenorphine use; 18 (35%) reported active community buprenorphine treatment prior to jail admission. Twenty-one of 26 assigned to XRB received 1 or more XRB injection prior to release; 3 initiated XRB postrelease; and 2 did not receive XRB. Patients in the XRB arm had fewer jail medical visits compared with daily SLB medication administration (mean [SD] visits per day: XRB, 0.11 [0.03] vs SLB, 1.06 [0.08]). Community buprenorphine treatment retention at week 8 postrelease was 18 participants in the XRB group (69.2%) vs 9 in the SLB group (34.6%), and rates of opioid-negative urine tests were 72 of 130 tests in the XRB group (55.3%) and 50 of 130 tests in the SLB group (38.4%). There were no differences in rates of serious adverse events, no overdoses, and no deaths. Conclusions and Relevance/UNASSIGNED:XRB was acceptable among patients currently receiving SLB, and patients had fewer in-jail clinic visits and increased community buprenorphine treatment retention when compared with standard daily SLB treatment. These results support wider use and further study of XRB as correctional and reentry OUD treatment. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03604159.

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.

As the world faced the devastation of the COVID-19 pandemic in late 2019 and early 2020, numerous clinical trials were initiated in many locations in an effort to establish the efficacy (or lack thereof) of potential treatments. As the pandemic has been shifting locations rapidly, individual studies have been at risk of failing to meet recruitment targets because of declining numbers of eligible patients with COVID-19 encountered at participating sites. It has become clear that it might take several more COVID-19 surges at the same location to achieve full enrollment and to find answers about what treatments are effective for this disease. This paper proposes an innovative approach for pooling patient-level data from multiple ongoing randomized clinical trials (RCTs) that have not been configured as a network of sites. We present the statistical analysis plan of a prospective individual patient data (IPD) meta-analysis (MA) from ongoing RCTs of convalescent plasma (CP). We employ an adaptive Bayesian approach for continuously monitoring the accumulating pooled data via posterior probabilities for safety, efficacy, and harm. Although we focus on RCTs for CP and address specific challenges related to CP treatment for COVID-19, the proposed framework is generally applicable to pooling data from RCTs for other therapies and disease settings in order to find answers in weeks or months, rather than years.

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

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/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: 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

BACKGROUND: Under-treatment of drug and alcohol use in primary care settings has been attributed, in part, to medical providers' negative attitudes toward substance use. As a part of an implementation study of electronic health record-integrated substance use screening in primary care clinics, conducted in the NIDA Clinical Trials Network, we assessed baseline attitudes among medical staff.
METHOD(S): Eligible participants were primary care providers and medical assistants in 4 urban academic primary care clinics. Prior to implementation of a substance use screening program, participants completed the Substance Abuse Attitudes Survey (SAAS), a validated 50-item self-administered survey that measures attitudes to substance use in 5 domains: permissiveness, non-moralism, nonstereotyping, treatment intervention, and treatment optimism. Participants were asked to rate their level of agreement with each item on a five-point Likert scale.
RESULT(S): In total, 131/191 (69% response rate) eligible staff completed the survey. Participants had mean age 42; 76% were female; 11% Hispanic/Latino, 6% Black, 25% Asian. The majority of the sample was physicians (78%), while 11% were nurse practitioners, and 11% were medical assistants. Participants had an overall average of 13.2 years in practice. Approximately onethird reported moderate to high satisfaction treating patients with drug problems (35.1%) and alcohol problems (33.6%). The proportion of participants having positive attitudes in each of the following domains were: non-moralism (64.1%); non-stereotyping (55.7%); treatment intervention (47.3%); treatment optimism (48.9%); and permissiveness (44.3%). Negative attitudes toward permissiveness reflect responses to items addressing health effects of substance use, especially among teens.
CONCLUSION(S): While most primary care staff did not endorse moralistic or stereotyping statements about alcohol and drug use, attitudes toward addiction treatment were mixed, with less than half endorsing positive attitudes toward treatment effectiveness. These results suggest a need to improve attitudes, particularly toward addiction treatment. This could be accomplished through education and increased exposure to effective interventions that can be delivered by primary care providers, including officebased treatment for alcohol and opioid use disorder