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Caregiver outcomes in nurse-led telephonic versus specialty palliative care for the seriously ill

Cooper, Richelle J; de la Rosa, Oscar; Flannery, Mara; Cuthel, Allison; Liddicoat Yamarik, Rebecca; Goldfeld, Keith S; Grudzen, Corita R; ,
OBJECTIVES/OBJECTIVE: Caregivers of persons living with serious illness suffer from stress, anxiety and depression. We aim to assess caregiver strain, quality of life (QOL) and bereavement of caregivers of patients enrolled in Emergency Medicine Palliative Care Access (EMPallA), a multicentre randomised controlled trial. METHODS:Patients and caregivers were recruited between April 2018 and June 2022 in 18 emergency departments in the USA. Caregiver inclusion criteria were 18 years or older, spoke English or Spanish, and were primary caregivers of enrolled patients. We randomised patient-caregiver dyads at the patient level. Caregivers were encouraged to accompany patients in both care models (nurse-led telephonic palliative care or specialty palliative care), although there was no specific caregiver intervention. We performed mixed effects linear regression models to assess change in caregiver strain and QOL at 6 months and bereavement. RESULTS:Among 323 caregivers, mean age was 56.9 (SD 14.2), 221 (68%) were female and 77 (24%) were Black. The analysis did not reveal any differences in caregiver strain, QOL, and bereavement between the two care models. The estimated difference in average change in strain scores between groups was -1.6 points (95% CI: -3.4 to 0.3), average change in caregiver physical QOL was 0.5 (95% CI: -0.9 to 1.8), average change in caregiver mental health QOL was 1.8 (95% CI: -0.1 to 3.6) and average change in bereavement scores was 1.8 (95% CI: -2.9 to 6.6). CONCLUSIONS:The study did not demonstrate that nurse-led telephonic care improved caregiver strain, QOL or bereavement outcomes compared with traditional outpatient palliative care. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT03325985.
PMID: 42749467
ISSN: 2045-4368
CID: 6072926

Assessing specification assumptions in urban pharmacy accessibility in New York City

Lawrence, Steven; Goldfeld, Keith S; Craigmile, Peter F; Blecker, Saul; Adhikari, Samrachana
BACKGROUND:Accurate measurement of pharmacy access is central to understanding spatial inequities in healthcare availability. The two-step floating catchment area (2SFCA) method is widely used to integrate proximity and availability, yet key challenges remain unresolved in dense urban settings, including catchment sensitivity, and the lack of uncertainty quantification despite reliance on survey-based population estimates. OBJECTIVE:To assess catchment sensitivity to specification using a mode-adjusted 2SFCA approach while propagating uncertainty from the American Community Survey (ACS). METHODS:We conducted a cross-sectional analysis of pharmacy access across 2222 census tracts in New York City using multiple distance- and time-based catchments. We applied a mode-adjusted 2SFCA method that incorporates walking and driving accessibility by decomposing populations demand using tract-level transportation proportions from the ACS. Uncertainty in access estimates was quantified via hierarchical Monte Carlo simulation propagating the margins of errors from the ACS. We used cross-tabulation to quantify agreement in classifying tracts as having fewer than one pharmacy per 10,000 residents across transportation modes. RESULTS:Relative pharmacy access patterns were stable across a wide range of catchment specifications, indicating limited sensitivity to reasonable changes in distance or travel-time thresholds in this dense urban setting. The mode-adjusted approach increased median access and introduced additional variability by accounting for transportation differences. Uncertainty in access estimates was generally negligible but may matter where driving and walking catchments do not overlap. CONCLUSIONS:These findings suggest that, in New York City, catchment size and ACS uncertainty have limited impact on access estimates, while transportation differences and border effects play a larger role.
PMCID:13547775
PMID: 42702484
ISSN: 1877-5853
CID: 6072194

The design of embedded pragmatic clinical trials: methodological developments and statistical lessons learned from the first cycle of the NIA IMPACT collaboratory

Travison, Thomas G; Davis-Plourde, Kendra; Goldfeld, Keith S; Li, Fan; Lou, Yifan; Monin, Joan K; Taljaard, Monica; Turner, Jeffrey; Vranceanu, Ana-Maria; Allore, Heather G
INTRODUCTION/BACKGROUND:The National Institute on Aging-funded IMbedded Pragmatic Alzheimer's disease and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory was established to build capacity for conducting embedded pragmatic clinical trials (ePCTs) within healthcare systems for people living with dementia and their care partners. Here we present methodology and describe lessons learned from the first five years of IMPACT's Design and Statistics Core (DSC). METHODS:The DSC assembled a multidisciplinary team focused on advancing the design, analysis, and implementation of ePCTs. RESULTS:The DSC developed and disseminated methods for design and sample size of cluster randomized designs with complex correlation structures; guidance for pilot ePCTs; approaches to patient-care partner ePCTs; approaches to testing health-equity-relevant hypotheses; and guidance for training quantitative and clinical scientists developing ePCTs. DISCUSSION/CONCLUSIONS:Key gaps remain in applying dyadic designs and when studying heterogeneity of treatment effects, which will be major priorities for the next funding cycle.
PMCID:13380667
PMID: 42471753
ISSN: 1552-5279
CID: 6070520

Nurse-Led Telephonic Care Following Emergency Department Visits for Persons Living With Dementia and Their Care Partners: A Program Description

Cotter, Valerie T; Grudzen, Corita R; Griffith, Janessa; Cuthel, Allison; Hoque, Afshana; Arbaje, Alicia I; Gettel, Cameron J; Durga, Aditi; Emami, Ariana; Goldfeld, Keith; Chodosh, Joshua; Shah, Manish N; Brody, Abraham A; ,
Most visits to the emergency department (ED) by persons living with dementia (PLWD) who are then discharged back into the community are preventable. However, care partners and other caregivers of the over 6 million PLWD residing in the United States lack the supports, services and timely access to clinical care to address many common needs in the community. Thus, care partners resort to taking the PLWD to the ED, a sub-optimal environment that can be traumatic to the PLWD, increase iatrogenesis, and ultimately may not resolve the underlying reason for the visit. Longitudinal nurse-led telephonic care (NLTC) provided following an ED visit with community discharge may present an effective and efficient model for health systems to support care partners, decant busy EDs, and provide high-quality, person and family-centered impactful care to support PLWD and their care partners. This paper describes the development of an NLTC program being implemented as part of the Emergency Departments LEading Transformation of Alzheimer's and Dementia Care (ED-LEAD) trial, a factorially designed embedded pragmatic clinical trial in 79 EDs. The NLTC program utilizes components of two previously tested programs, the Aliviado Dementia Care quality improvement program, and the Emergency Medicine Palliative Care Access (EMPallA) nurse-led telephonic palliative and transitional care program to support PLWD and their care partners. Successful implementation of the NLTC program may lead to increased uptake of NLTC programs by health systems, improving quality of care and quality of life for PLWD and their care partners.
PMID: 42166326
ISSN: 1532-5415
CID: 6038512

Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care [Editorial]

Grudzen, Corita R; Brody, Abraham A; Chodosh, Joshua; Goldfeld, Keith S; Shah, Manish N
PMID: 42095683
ISSN: 1532-5415
CID: 6031472

Care trajectories among people with opioid use disorder after release from New York City jails: A state sequence analysis approach

Cherian, Teena; Bórquez, Ignacio; Krawczyk, Noa; Katyal, Monica; Goldfeld, Keith S; Wiewel, Ellen; Khan, Maria; Braunstein, Sarah L; Murphy, Sean M; Jalali, Ali; Oyemakinde, Babasoji; Jeng, Philip J; Rosner, Zachary; MacDonald, Ross; Lee, Joshua D; Lim, Sungwoo
BACKGROUND:Individuals with opioid use disorder (OUD) may experience fewer barriers to treatment following incarceration if offered in-jail medications for OUD (MOUD). We aimed to identify care trajectories of community OUD treatment after incarceration and examine the association between receiving in-jail MOUD and experiencing specific community treatment trajectories. METHODS:This retrospective cohort study using matched New York City (NYC) health care administrative data included adults with OUD incarcerated on or after May 2011 and discharged during 2014-2017. We defined states of community OUD treatment at the weekly level over one year following index jail discharge and performed state sequence analysis (SSA) to identify trajectories of treatment after jail and assessed the influence of receiving in-jail MOUD on treatment trajectories. RESULTS:Of 14,923 eligible individuals, 26.2% received in-jail MOUD. SSA identified eight clusters of community care trajectories: continuous methadone treatment (9.7%), methadone treatment discontinuation (3.7%), methadone treatment and reincarceration (6.7%), methadone treatment initiation (4.8%), continuous reincarceration (3.5%), short reincarceration with little community treatment (20.3%), long reincarceration with little community treatment (7.0%), and no community OUD treatment or reincarceration (44.5%). Receiving in-jail MOUD was associated with belonging to the continuous methadone treatment cluster compared to the no community OUD treatment or reincarceration cluster (adjusted OR: 12.5, 95% CI: 9.9-15.7). CONCLUSION/CONCLUSIONS:We identified eight unique patterns of community OUD treatment after jail release. Receipt of in-jail MOUD was associated with belonging to the continuous methadone treatment cluster. These findings suggest that provision of in-jail MOUD could improve methadone uptake in the community.
PMID: 42066528
ISSN: 1879-0046
CID: 6029722

Bridging the Gap Between the ED and Home: The Community Paramedic-Led Transitions Intervention for Persons Living With Dementia

Morales, Meghan Jenkins; Ricketts, Stephanie; Grudzen, Corita R; Brody, Abraham A; Chodosh, Joshua; Goldfeld, Keith; Shah, Manish N; ,
More than 6 million persons living with dementia (PLWD) in the United States rely on the emergency department (ED) for unscheduled care, with up to half discharged home after treatment. The ED-to-home transition poses significant challenges for PLWD and their care partners (referred to as "dyads"), contributing to high rates of ED revisits and adverse outcomes. The Community Paramedic-led Transitions Intervention (CPTI) was developed to address these challenges by adapting the validated Care Transitions Intervention for the ED setting. Delivered by trained community paramedics, CPTI is a short-term 30-day program that includes one home visit and up to three follow-up phone calls. Using a coaching model, paramedic coaches work with members of the dyad to strengthen their knowledge, skills, and confidence to manage their health and successfully navigate the health care system. CPTI is being implemented as part of Emergency Departments LEading the Transformation of Alzheimer's and Dementia Care (ED-LEAD), a cluster-randomized pragmatic trial testing 3 interventions designed to improve outcomes for PLWD discharged home from the ED across 14 health systems and 79 EDs nationwide. This paper describes the CPTI model as implemented within ED-LEAD, detailing its theoretical foundation, structure, training curriculum, workflow integration, and implementation monitoring. This framework can provide a model for health systems, provider groups, and emergency medical service agencies interested in adopting this innovative approach and implementing the CPTI. Insights from its implementation within ED-LEAD will guide future efforts to improve post-ED outcomes and continuity of care for PLWD and their care partners.
PMID: 41987015
ISSN: 1532-5415
CID: 6027982

A Pilot Randomized Controlled Trial of Integrated Nephrology and Palliative Care Implemented at a Safety-Net Hospital

Scherer, Jennifer S; Yassin, Sallie; Xia, Yuhe; Goldfeld, Keith S; Caplin, Nina; Cohen, Susan; Brody, Abraham A; Chodosh, Joshua; McCarthy, Angela; Krishnamurthy, Pragna; Gross, Haley; Melamed, Michal; Charytan, David M
RATIONALE & OBJECTIVE/UNASSIGNED:Randomized controlled trials (RCTs) show that integrated palliative care can improve symptoms compared with usual care in many serious illnesses, yet there are no comparable RCTs in chronic kidney disease (CKD). STUDY DESIGN/UNASSIGNED:We conducted a pilot feasibility RCT comparing kidney palliative care (KPC) integrated with CKD care with usual CKD care. SETTING & PARTICIPANTS/UNASSIGNED:English and Spanish speakers aged ≥18 years with CKD stage IV and V, or receiving dialysis, seen at an urban safety-net hospital. EXPOSURES/UNASSIGNED:Participants were randomized to usual CKD care or to usual CKD care plus 6-monthly ambulatory KPC visits. OUTCOMES/UNASSIGNED:Primary outcomes were feasibility of recruitment, retention, intervention delivery, and data collection. Secondary outcomes included change in symptom burden at 6 months, measured by the Integrated Palliative Outcome Scale (IPOS)-Renal (lower scores represent lower burden), quality of life measured by the Kidney Disease Quality of Life 36-item survey, and engagement in advance care planning. ANALYTICAL APPROACH/UNASSIGNED:Feasibility outcomes are reported as proportions and clinical outcomes as descriptive summaries of change in scores. RESULTS/UNASSIGNED:Of the 146 people approached, 84 (56%) consented, 75 (89%) were randomized, and 57 (76%) completed the trial. 56% of participants were Hispanic and 32% were Black, with 49% on Medicaid and 13% uninsured. The mean age of participants was 61 years, and 31% were receiving dialysis. A mean of 4-6 intervention visits was attended. At 6 months, the intervention group had a 4.1-point decrease in IPOS score (standard deviation 13.4), whereas the mean IPOS score of the control group increased by 0.6 points (standard deviation 7.8) from baseline. LIMITATIONS/UNASSIGNED:Small sample size and limited number of providers to assess generalizability. CONCLUSIONS/UNASSIGNED:We demonstrate the feasibility of an RCT comparing integrated KPC with usual CKD care in a safety-net hospital. Although this study was not powered to detect significance in change of clinical outcomes, our findings suggest that there is value in testing KPC in efficacy trials and that these are feasible.
PMCID:13069507
PMID: 41971229
ISSN: 2590-0595
CID: 6027432

Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care: Emergency Care Redesign

Hoque, Afshana; Cuthel, Allison; Grudzen, Corita R; Shah, Manish N; Brody, Abraham A; Fleisher, Jori E; DiMascio-Donohue, Jennifer; McLain, Katelyn; Tun, Lin T; Levine, Julia; Goldfeld, Keith S; Chodosh, Joshua; ,
Over 50% of persons living with dementia (PLWD) and their care partners (dyads) visit the emergency department (ED) every year. In the ED, healthcare professionals face complex challenges managing acute issues and symptoms of Alzheimer's disease and Alzheimer's disease-related dementias without provider training or in-ED structures to ensure a successful discharge. While many of these visits are for conditions more suitable for ambulatory care, as many as 50% of PLWD discharged from the ED return within 30 days, suggesting opportunities to improve ED care, and discharge processes. Emergency Care Redesign (ECR) includes intentional workflows where physicians, nurses, and social workers engage in a team-based approach with structured assessments to manage a myriad of potential psychosocial and behavioral issues contributing to the need for ED care. Three core components comprise this evidence-based, efficient pragmatic intervention for PLWD and their care partners: (1) problem identification, (2) problem prioritization, and (3) provision of non-pharmacologic solutions supported by community resources. Although these components are essential to provide optimal ED care and reduce revisits and other adverse outcomes, they require an embedded clinical decision support structure, focused training, and clear workflows. In this paper, we describe the ECR intervention as one of three being implemented in the cluster-randomized multifactorial pragmatic trial, Emergency Departments LEading Transformation of Alzheimer's and Dementia Care (ED-LEAD), designed to improve care for PLWD and their outcomes after discharge home within 15 health systems and 79 EDs across the United States.
PMID: 41882986
ISSN: 1532-5415
CID: 6018362

Study protocol: feasibility of a hearing program in primary care for underserved older adults

Friedmann, David R; Diminich, Leah N; Spitzer, Emily R; Ajmal, Saima; Weinstein, Barbara; Dickson, Victoria; Goldfeld, Keith S; Chodosh, Joshua
BACKGROUND:Age-related hearing loss is highly prevalent, underrecognized, and consequently, undertreated. Hearing loss can have a substantial negative impact on communication and biopsychosocial health. We hypothesize that offering validated hearing assessments and a point-of-care counseling program in an older, underserved population will be more accessible and acceptable than the traditional pathway for audiology care, particularly in marginalized communities. METHODS:This convergent mixed methods feasibility study will assess the implementation of a hearing program embedded in a quality improvement initiative within the Geriatric Clinic of New York City Health and Hospital's Bellevue Hospital Center and the feasibility of recruiting for a future efficacy trial to test the intervention. Adult patients ≥ 60 years who are proficient in English or Spanish and not currently using hearing rehabilitation are eligible for initial screening. Hearing level, including individual ear severity, is identified using a validated tablet-based measure of pure tone audiometry and a self-report measure of hearing disability. We define hearing loss subjectively based on a score of 8 or greater on the Hearing Handicap Inventory-Screen (HHI-S) or using a four-frequency pure tone average > 25 dB hearing level in the better ear, representing at least a mild hearing loss. Patients who are determined to have measurable hearing loss and provide informed consent will be invited to participate in a pilot study and randomized to one of two approaches: (1) a counseling on alternative rehabilitation strategies intervention arm or (2) usual care with referral to the audiology pathway. Primary feasibility outcomes include recruitment and retention rates, intervention adherence, acceptability, and the ability to collect outcome measurements. We will also explore changes in HHI-S scores over 3 months and assess subsequent audiology service utilization in both groups. In addition to the quantitative data, we will include key participant interviews with staff and patients to assess feasibility from participant attitudes. DISCUSSION/CONCLUSIONS:This study will provide insights into the feasibility of offering hearing screening/assessments and counseling in primary care and its potential to improve access to hearing care for underserved older adults. Findings will inform the design of future trials evaluating the impact of primary care-based tailored hearing interventions on patient health and quality of life. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05943509, Trial registration date: July 13, 2023, Protocol Version: 1.
PMID: 41736137
ISSN: 2055-5784
CID: 6009912