Faculty Bibliography

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.

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.

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.

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.

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.

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.

OBJECTIVE/UNASSIGNED:To compare the effectiveness of nurse led telephonic palliative care versus specialty outpatient palliative care on quality of life, symptom burden, loneliness, and healthcare use, after attending the emergency department. DESIGN/UNASSIGNED:Pragmatic, randomised clinical trial. SETTING/UNASSIGNED:Emergency Medicine Palliative Care Access (EMPallA) randomised controlled trial enrolling participants from 18 emergency departments in 15 geographically diverse healthcare systems in nine US states, from 1 April 2018 to 30 June 2022. PARTICIPANTS/UNASSIGNED:Of 39 254 eligible patients, 1283 adults who visited the emergency department, were aged ≥50 years, who spoke English or Spanish, and had advanced cancer or end stage organ failure, were randomised to receive nurse led telephonic palliative care (n=639) or specialty outpatient palliative care (n=644). INTERVENTIONS/UNASSIGNED:The nurse led telephonic palliative care arm consisted of weekly or biweekly calls over six months made by registered nurses certified in hospice and palliative care. For the specialty outpatient palliative care arm, patients had one visit each month for six months with a specialty trained hospice and palliative medicine provider. MAIN OUTCOME MEASURES/UNASSIGNED:The primary outcome was change in patient reported quality of life at six months, measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Secondary outcomes were change in symptom burden and patient reported loneliness after six months, and healthcare use, measured as the number of emergency department revisits, inpatient days, and hospice use, from enrolment to 12 months. RESULTS/UNASSIGNED:639 patients were assigned to nurse telephonic services and 434 (68%) engaged in care until death, or until they required hospice services or graduated from the programme. For specialty outpatient palliative care, 644 patients were assigned and 344 (53%) attended one or more visits, with an average of 2.7 visits. The mean change in FACT-G scores over six months for the nurse telephonic arm (n=418) was 3.7 (95% confidence interval (CI) 2.3 to 5.1) points compared with 3.1 (1.6 to 4.6) for those in the specialty outpatient care arm (n=409). In the model including all patients who survived to six months (n=1090), the estimated difference in average change in quality of life was 0.71 (95% CI -1.19 to 2.61) points higher in the nurse led telephonic palliative care arm. The analysis did not show any clinically meaningful differences in the change in quality of life between the treatment arms. Also, no important differences between groups were found for secondary outcomes or in subgroup analyses. CONCLUSIONS/UNASSIGNED:The results of the study provided no clear evidence that nurse led telephonic palliative care improved quality of life, or any secondary outcomes, relative to specialty outpatient palliative care. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov NCT03325985.

Stepped wedge cluster randomized trials (SW-CRTs) are a type of uni-directional crossover designs and are increasingly common in prevention and implementation research. Although sample size formulas have been developed to support the planning of SW-CRTs, almost no prior methods incorporated the baseline measurement of the outcome-a common feature in many randomized trials and, increasingly, in cross-sectional SW-CRTs. In this article, we systematically investigate the possibility of addressing a baseline outcome measurement in designing cross-sectional SW-CRTs. We provide three linear mixed modeling approaches to adjust for the baseline outcome and derive the corresponding variance formula of the treatment effect estimator under each. The derived formulas reveal the efficiency implications of including a baseline outcome measurement, and provide a natural vehicle for the efficiency comparisons across adjustment approaches to generate practical recommendations. We validate the power and sample size methods under each baseline adjustment approach using simulations and provide an illustrative sample size calculation with a baseline outcome using the context of a real SW-CRT.

Factorial study designs can be important for understanding the effectiveness of interventions when multiple interventions are under investigation. In this design setting, a unit of randomization can be assigned to any combination of interventions. The rationale for taking this kind of approach can vary depending on the specific questions targeted by the research. These questions, in turn, have implications for the way in which the analyses will be conducted. The goal in this paper is to describe how we developed a factorial design along with a Bayesian analytic plan for a large cluster-randomized trial-the Emergency Departments LEading the transformation of Alzheimer's and Dementia care (ED-LEAD) study-focused on improving care for persons living with dementia.