Corita R. Grudzen

Stepped wedge cluster randomized trials (SWCRTs) often face challenges with potential confounding by time trends. Traditional frequentist methods can fail to provide adequate coverage of the intervention's true effect using confidence intervals, whereas Bayesian approaches show potential for better coverage of intervention effects. However, Bayesian methods have seen limited development in SWCRTs. We propose two novel Bayesian hierarchical penalized spline models for SWCRTs. The first model is for SWCRTs involving many clusters and time periods, focusing on immediate intervention effects. To evaluate its efficacy, we compared this model to traditional frequentist methods. We further developed the model to estimate time-varying intervention effects. We conducted a comparative analysis of this Bayesian spline model against an existing Bayesian monotone effect curve model. The proposed models are applied in the Primary Palliative Care for Emergency Medicine stepped wedge trial to evaluate the effectiveness of primary palliative care intervention. Extensive simulations and a real-world application demonstrate the strengths of the proposed Bayesian models. The Bayesian immediate effect model consistently achieves near the frequentist nominal coverage probability for true intervention effect, providing more reliable interval estimations than traditional frequentist models, while maintaining high estimation accuracy. The proposed Bayesian time-varying effect model exhibits advancements over the existing Bayesian monotone effect curve model in terms of improved accuracy and reliability. To the best of our knowledge, this is the first development of Bayesian hierarchical spline modeling for SWCRTs. The proposed models offer an accurate and robust analysis of intervention effects. Their application could lead to effective adjustments in intervention strategies.

Background: Older adults with cognitive impairment have more emergency department visits and 30-day readmissions and are more likely to die after visiting the emergency department than people without cognitive impairment. Emergency department providers frequently do not identify cognitive impairment. Use of cognitive screening tools, along with better understanding of root causes for emergency department visits, could equip health care teams with the knowledge needed to develop individually tailored care management strategies for post–emergency department care. By identifying and directly addressing patients’ and informal caregivers’ (or care partners’) psychosocial and health care needs, such strategies could reduce the need for repeat acute care. We have used the terms “caregiver” and “care partner” interchangeably. Objective: We aimed to describe the protocol for a randomized controlled trial of a new care management intervention, the Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED) trial, compared with usual care. We described the research design, intervention, outcome measures, data collection techniques, and analysis plans. Methods: Emergency department patients who were aged ≥75 years and screened positive for cognitive impairment via either the Mini-Cog or the proxy-reported Short Informant Questionnaire on Cognitive Decline in the Elderly, with a planned discharge to home, were recruited to participate with their identified informal (family or friend) caregiver in the 2-site POISED randomized controlled trial at New York University Langone Health and Indiana University. The intervention group received 6 months of care management from the POISED Care Team of registered nurses and specialty-trained paraprofessionals, who perform root cause analyses, administer standardized assessments, provide advice, recommend appropriate referrals, and, when applicable, implement dementia-specific comorbid condition protocols. The control group received care as recommended at emergency department discharge (usual care) and were given information about resources for further cognitive assessment. The primary outcome is repeat emergency department use; secondary outcomes include caregiver activation for patient health care management, caregiver depression, anxiety, and experience of social support as important predisposing and time-varying enabling and need characteristics. Data were collected from questionnaires and patients’ electronic health records. Results: Recruitment was conducted between March 2018 and May 2021. Study findings will be published in peer-reviewed journals and presented to peer audiences, decision makers, stakeholders, and other interested persons. Conclusions: The POISED intervention is a promising approach to tailoring care management based on root causes for emergency department admission of patients with cognitive impairment with the aim of reducing readmissions. This trial will provide insights for caregivers and emergency department and primary care providers on appropriate, personalized, and proactive treatment plans for older adults with cognitive impairment. The findings will be relevant to audiences concerned with quality of life for individuals with cognitive impairment and their caregivers. Trial Registration: ClinicalTrials.gov NCT03325608; https://clinicaltrials.gov/ct2/show/NCT03325608 International Registered Report Identifier (IRRID): DERR1-10.2196/36607

Eighty-one percent of persons living with cancer have an emergency department (ED) visit within the last 6 months of life. Many cancer patients in the ED are at an advanced stage with high symptom burden and complex needs, and over half is admitted to an inpatient setting. Innovative models of care have been developed to provide high quality, ambulatory, and home-based care to persons living with serious, life-limiting illness, such as advanced cancer. New care models can be divided into a number of categories based on either prognosis (e.g., greater than or less than 6 months), or level of care (e.g., lower versus higher intensity needs, such as intravenous pain/nausea medication or frequent monitoring), and goals of care (e.g., cancer-directed treatment versus symptom-focused care only). We performed a narrative review to (1) compare models of care for seriously ill cancer patients in the ED and (2) examine factors that may hasten or impede wider dissemination of these models.

BACKGROUND Older adults with cognitive impairment have more Emergency Department (ED) visits and 30-day readmissions and are more likely to die after visiting the ED than people without cognitive impairment. ED providers frequently do not identify cognitive impairment in the older adults. Use of cognitive screening tools, in combination with better understanding of root causes for ED visits, could equip healthcare teams with the knowledge they need to develop individually tailored care management strategies for post-ED care. By identifying and directly addressing patients’ and informal caregivers’ (or care partners’) psychosocial and healthcare needs, such strategies could reduce the need for repeat acute care. We use the terms ‘caregiver’ and ‘care partner’ interchangeably. OBJECTIVE This paper describes the protocol for a randomized controlled trial of a new care management intervention, “Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients Trial” (POISED) compared to usual care. We describe the research design, intervention, outcome measures, data collection techniques, and analysis plan. METHODS ED patients >75 years who screen positive for cognitive impairment via either the Mini-Cog or the proxy-reported Short Informant Questionnaire on Cognitive Decline in the Elderly, with a planned discharge to home, are recruited to participate with their identified informal (family or friend) caregiver in a 2-site randomized controlled trial of POISED at New York University Langone Health and Indiana University. The intervention group receives 6 months of care management provided by the POISED Care Team of registered nurses and specialty-trained paraprofessionals, who perform root cause analyses, administer standardized assessments, provide advice, recommend appropriate referrals, and, when applicable, implement dementia-specific co-morbid condition protocols. The control group receives care as recommended at ED discharge (usual care) and are given information about resources for further cognitive assessment. The primary outcome is repeat ED use; secondary outcomes include caregiver activation for patient healthcare management, caregiver depression, anxiety, and experience of social support as important predisposing and time-varying enabling and need characteristics. Data are collected from questionnaires and patient electronic health records. RESULTS Recruitment occurred from March 2018 through May 2021. Study findings will be published in peer-reviewed journals, and presented to peer audiences, decision makers, stakeholders, and other interested persons. CONCLUSIONS The POISED intervention is a promising approach to tailoring care management based on root causes for ED admission of cognitively impaired patients with the aim of reducing readmissions. This trial will provide insights for caregivers and ED and primary care providers on appropriate, personalized, and proactive treatment plans for cognitively impaired older adults. Findings will be relevant to all audiences concerned with quality of life for individuals with cognitive impairment and their caregivers. CLINICALTRIAL ClinicalTrials.gov (NCT03325608) registered on October 30, 2017.

Purpose Many patients with cancer seek care for pain in the emergency department (ED). Prospective research on cancer pain in this setting has historically been insufficient. We conducted this study to describe the reported pain among cancer patients presenting to the ED, how pain is managed, and how pain may be associated with clinical outcomes. Methods We conducted a multicenter cohort study on adult patients with active cancer presenting to 18 EDs in the USA. We reported pain scores, response to medication, and analgesic utilization. We estimated the associations between pain severity, medication utilization, and the following outcomes: 30-day mortality, 30-day hospital readmission, and ED disposition. Results The study population included 1075 participants. Those who received an opioid in the ED were more likely to be admitted to the hospital and were more likely to be readmitted within 30 days (OR 1.4 (95% CI: 1.11, 1.88) and OR 1.56 (95% CI: 1.17, 2.07)), respectively. Severe pain at ED presentation was associated with increased 30-day mortality (OR 2.30, 95% CI: 1.05, 5.02), though this risk was attenuated when adjusting for clinical factors (most notably functional status). Conclusions Patients with severe pain had a higher risk of mortality, which was attenuated when correcting for clinical characteristics. Those patients who required opioid analgesics in the ED were more likely to require admission and were more at risk of 30-day hospital readmission. Future efforts should focus on these at-risk groups, who may benefit from additional services including palliative care, hospice, or home-health services.

Annually, approximately 30 million patients are discharged from the emergency department (ED) after a traumatic event¹. These patients are at substantial psychiatric risk, with approximately 10–20% developing one or more disorders, including anxiety, depression or post-traumatic stress disorder (PTSD)^2,3,4. At present, no accurate method exists to predict the development of PTSD symptoms upon ED admission after trauma⁵. Accurate risk identification at the point of treatment by ED services is necessary to inform the targeted deployment of existing treatment^6,7,8,9 to mitigate subsequent psychopathology in high-risk populations^10,11. This work reports the development and validation of an algorithm for prediction of post-traumatic stress course over 12 months using two independently collected prospective cohorts of trauma survivors from two level 1 emergency trauma centers, which uses routinely collectible data from electronic medical records, along with brief clinical assessments of the patient’s immediate stress reaction. Results demonstrate externally validated accuracy to discriminate PTSD risk with high precision. While the predictive algorithm yields useful reproducible results on two independent prospective cohorts of ED patients, future research should extend the generalizability to the broad, clinically heterogeneous ED population under conditions of routine medical care.