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Racial and Ethnic Disparities in Analgesics and Antipsychotics Use among Persons with Advanced Dementia in Home Hospice [Meeting Abstract]

Gonzalez, L; Lassell, R; Ford, A; Xu, Y; Goldfeld, K; Brody, A
Background: Significant racial and ethnic disparities exist in the community in underprescribing analgesics for pain and overprescribing antipsychotics for behavioral symptoms in persons with dementia. In hospice these drugs are commonly used to provide comfort, but little is known about prescription patterns in minoritized populations. We aimed to identify prescribing patterns in minoritized racial and ethnic groups among persons with living advanced dementia in home hospice.
Method(s): A cross-sectional study of 6,874 participants with advanced dementia from eight hospices across the United States. Demographics, antipsychotic (typical, atypical) and analgesic (opioid, non-opioid) prescriptions at admission, days of prescription use in hospice and length of stay were collected from electronic records. Descriptive statistics were calculated and hurdle regression models estimated to examine the association between race/ethnicity and prescription rates for each drug (days of drug use per 100 person-days).
Result(s): Participants were 10.7% Black, 34.8% Hispanic, 51.1% white, and 3.3% from other racial and ethnic groups. On admission, Hispanics and Blacks had similar rates of antipsychotic prescription that were lower than whites (11.9% & 12.3% vs 16.8%) and Hispanics had substantially lower non-opioid analgesic prescription vs Blacks and whites (23.3% vs 36.0% & 37.3%); During the hospice stay, Hispanics were prescribed antipsychotics (atypical RR =1.03, 95 % CI: 1.02-1.04; typical RR:1.04, 95% CI: 1.01-1.07) and analgesics (opioid RR =1.03, 95% CI: 1.02-1.04; non-opioid RR = 1.03, 95% CI = 1.02-1.03) for more days than whites. Blacks were prescribed analgesics (opioid RR =1.09, 95% CI 1.08-1.11; non-opioid RR = 1.01, 95% CI: 1-1.02) for more days than whites.
Conclusion(s): Disparities in analgesic and antipsychotic use on admission amongst Blacks and Hispanics were found, yet hospice narrowed this gap significantly. While less likely to be prescribed opioids, Blacks and Hispanics had more person days on analgesics overall. However, there was divergence in antipsychotic use over time between groups that requires further investigation given the controversial role of antipsychotics in management of dementia symptoms
EMBASE:637954185
ISSN: 1531-5487
CID: 5292602

Clinical and genomic signatures of rising SARS-CoV-2 Delta breakthrough infections in New York

Duerr, Ralf; Dimartino, Dacia; Marier, Christian; Zappile, Paul; Levine, Samuel; François, Fritz; Iturrate, Eduardo; Wang, Guiqing; Dittmann, Meike; Lighter, Jennifer; Elbel, Brian; Troxel, Andrea B; Goldfeld, Keith S; Heguy, Adriana
In 2021, Delta has become the predominant SARS-CoV-2 variant worldwide. While vaccines effectively prevent COVID-19 hospitalization and death, vaccine breakthrough infections increasingly occur. The precise role of clinical and genomic determinants in Delta infections is not known, and whether they contribute to increased rates of breakthrough infections compared to unvaccinated controls. Here, we show a steep and near complete replacement of circulating variants with Delta between May and August 2021 in metropolitan New York. We observed an increase of the Delta sublineage AY.25, its spike mutation S112L, and nsp12 mutation F192V in breakthroughs. Delta infections were associated with younger age and lower hospitalization rates than Alpha. Delta breakthroughs increased significantly with time since vaccination, and, after adjusting for confounders, they rose at similar rates as in unvaccinated individuals. Our data indicate a limited impact of vaccine escape in favor of Delta's increased epidemic growth in times of waning vaccine protection.
PMCID:8669846
PMID: 34909779
ISSN: n/a
CID: 5085062

Prospective individual patient data meta-analysis: Evaluating convalescent plasma for COVID-19

Goldfeld, Keith S; Wu, Danni; Tarpey, Thaddeus; Liu, Mengling; Wu, Yinxiang; Troxel, Andrea B; Petkova, Eva
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.
PMID: 34164838
ISSN: 1097-0258
CID: 4918612

Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail

Lee, Joshua D; Malone, Mia; McDonald, Ryan; Cheng, Anna; Vasudevan, Kumar; Tofighi, Babak; Garment, Ann; Porter, Barbara; Goldfeld, Keith S; Matteo, Michael; Mangat, Jasdeep; Katyal, Monica; Giftos, Jonathan; MacDonald, Ross
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.
PMCID:8427378
PMID: 34495340
ISSN: 2574-3805
CID: 5011982

Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS)

Waddell, Elizabeth Needham; Springer, Sandra A; Marsch, Lisa A; Farabee, David; Schwartz, Robert P; Nyaku, Amesika; Reeves, Rusty; Goldfeld, Keith; McDonald, Ryan D; Malone, Mia; Cheng, Anna; Saunders, Elizabeth C; Monico, Laura; Gryczynski, Jan; Bell, Kathleen; Harding, Kasey; Violette, Sandra; Groblewski, Thomas; Martin, Wendy; Talon, Kasey; Beckwith, Nicole; Suchocki, Andrew; Torralva, Randy; Wisdom, Jennifer P; Lee, Joshua D
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.
PMCID:8384640
PMID: 33865691
ISSN: 1873-6483
CID: 5066472

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial

Spruill, Tanya M; Friedman, Daniel; Diaz, Laura; Butler, Mark J; Goldfeld, Keith S; O'Kula, Susanna; Montesdeoca, Jacqueline; Payano, Leydi; Shallcross, Amanda J; Kaur, Kiranjot; Tau, Michael; Vazquez, Blanca; Jongeling, Amy; Ogedegbe, Gbenga; Devinsky, Orrin
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.
PMID: 33963873
ISSN: 1613-9860
CID: 4866912

Data from emergency medicine palliative care access (EMPallA): a randomized controlled trial comparing the effectiveness of specialty outpatient versus telephonic palliative care of older adults with advanced illness presenting to the emergency department

Schmucker, Abigail M; Flannery, Mara; Cho, Jeanne; Goldfeld, Keith S; Grudzen, Corita
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.
PMCID:8272986
PMID: 34247588
ISSN: 1471-227x
CID: 4938132

The HEAR-VA Pilot Study: Hearing Assistance Provided to Older Adults in the Emergency Department

Chodosh, Joshua; Goldfeld, Keith; Weinstein, Barbara E; Radcliffe, Kate; Burlingame, Madeleine; Dickson, Victoria; Grudzen, Corita; Sherman, Scott; Smilowitz, Jessica; Blustein, Jan
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.
PMID: 33576037
ISSN: 1532-5415
CID: 4780132

Care trajectories of older adults with alzheimer disease in the emergency setting [Meeting Abstract]

Schmucker, A M; Hill, J; Siman, N; Goldfeld, K S; Cuthel, A M; Grudzen, C R
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
EMBASE:634826374
ISSN: 1532-5415
CID: 4870632

Conservative kidney management practice patterns in The United States: A ckdopps analysis [Meeting Abstract]

Scherer, J S; Muenz, D G; Bieber, B; Stengel, B; Masud, T; Robinson, B M; Pecoits-Filho, R; Goldfeld, K S; Chodosh, J; Charytan, D M
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
EMBASE:636328616
ISSN: 1533-3450
CID: 5179742