Allison M. Cuthel

Objectives: 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: NCT03325985 .

Objective: 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: Pragmatic, randomised clinical trial. Setting: 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: 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: 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: 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: 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: 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: ClinicalTrials.gov NCT03325985 .

Background: Loneliness is a quality-of-life (QoL) concern for patients facing serious, life-limiting illnesses. Discerning risk factors of loneliness in palliative care patients allows providers to take preventative action and develop holistic treatment plans. Methods: A planned sub-study of patients who completed the previously developed Three-Item Loneliness Scale upon enrollment into the multicenter, randomized clinical trial Emergency Medicine Palliative Care Access (EMPallA) with the objective of investigating the association of multimorbidity with loneliness in patients with late-stage illnesses. The EMPallA study included patients who were at least 50 years old and diagnosed with at least one end-stage illness (advanced cancer, advanced congestive heart failure (CHF), end-stage renal disease (ESRD), or advanced chronic obstructive pulmonary disease (COPD)). Results: We analyzed 1,212 surveys using a mixed-effects logistic regression model. Our findings suggest those with a single illness are less likely to be lonely than those with multimorbidity (odds ratio [OR] = 0.5, 95% CI 0.3 to 0.8). Additionally, older age was associated with less loneliness (OR comparing age by 10-year increments is 0.7 [95% CI: 0.6 to 0.9]), after adjusting for disease type, education level, race, sex, immigrant status, having a caregiver, COVID-19 period, language, and site geographic location. Conclusions: Patients suffering from multimorbidity self-report being “very lonely” more often than patients with a single advanced illness; furthermore, advanced illness patients who were middle-aged (versus elderly) were 25% more likely to report being “very lonely.” Trial registration: Clinicaltrials.gov identifier: NCT03325985. Registered October 30, 2017.

Background: Pre-injury frailty among older adults with trauma injuries is a predictor of increased morbidity and mortality. Objectives: We sought to determine the relationship between frailty status and the care trajectories of older adult patients who underwent frailty screening in the emergency department (ED). Methods: Using a retrospective cohort design, we pooled trauma data from a single institutional trauma database from August 2020 to June 2023. We limited the data to adults 65 years and older, who had trauma injuries and frailty screening at ED presentation (N = 2,862). The predictor variable was frailty status, measured as either robust (score 0), pre-frail (score 1–2), or frail (score 3–5) using the FRAIL index. The outcome variables were measures of clinical care trajectory: trauma team activation, inpatient admission, ED discharge, length of hospital stay, in-hospital death, home discharge, and discharge to rehabilitation. We controlled for age, sex, race/ethnicity, health insurance type, body mass index, Charlson Comorbidity Index, injury type and severity, and Glasgow Coma Scale score. We performed multivariable logistic and quantile regressions to measure the influence of frailty on post-trauma care trajectories. Results: The mean (SD) age of the study population was 80 (8.9) years, and the population was predominantly female (64%) and non-Hispanic White (60%). Compared to those classified as robust, those categorized as frail had 2.5 (95% CI: 1.86–3.23), 3.1 (95% CI: 2.28–4.12), and 0.3 (95% CI: 0.23–0.42) times the adjusted odds of trauma team activation, inpatient admission, and ED discharge, respectively. Also, those classified as frail had significantly longer lengths of hospital stay as well as 3.7 (1.07–12.62), 0.4 (0.28–0.47), and 2.2 (95% CI: 1.71–2.91) times the odds of in-hospital death, home discharge, and discharge to rehabilitation, respectively. Conclusion: Pre-injury frailty is a predictor of clinical care trajectories for older adults with trauma injuries.

Background: EM Talk is a communication skills training program designed to improve emergency providers’ serious illness conversational skills. Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this study aims to assess the reach of EM Talk and its effectiveness. Methods: EM Talk consisted of one 4-h training session during which professional actors used role-plays and active learning to train providers to deliver serious/bad news, express empathy, explore patients’ goals, and formulate care plans. After the training, emergency providers filled out an optional post-intervention survey, which included course reflections. Using a multi-method analytical approach, we analyzed the reach of the intervention quantitatively and the effectiveness of the intervention qualitatively using conceptual content analysis of open-ended responses. Results: A total of 879 out of 1,029 (85%) EM providers across 33 emergency departments completed the EM Talk training, with the training rate ranging from 63 to 100%. From the 326 reflections, we identified meaning units across the thematic domains of improved knowledge, attitude, and practice. The main subthemes across the three domains were the acquisition of Serious Illness (SI) communication skills, improved attitude toward engaging qualifying patients in SI conversations, and commitment to using these learned skills in clinical practice. Conclusion: Our study showed the extensive reach and the effectiveness of the EM Talk training in improving SI conversation. EM Talk, therefore, can potentially improve emergency providers’ knowledge, attitude, and practice of SI communication skills. Trial registration: Clinicaltrials.gov: NCT03424109; Registered on January 30, 2018.

Background: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. Methods: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project’s duration. Results: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. Conclusions: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. Trial Registration: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members’ lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.