Serious illness communication skills training for emergency physicians and advanced practice providers: a multi-method assessment of the reach and effectiveness of the intervention.

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.

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

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.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

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.

Emergency Nurses' Perceived Barriers and Solutions to Engaging Patients With Life-Limiting Illnesses in Serious Illness Conversations: A United States Multicenter Mixed-Method Analysis.

INTRODUCTION: This study aimed to assess emergency nurses' perceived barriers toward engaging patients in serious illness conversations. METHODS: Using a mixed-method (quant + QUAL) convergent design, we pooled data on the emergency nurses who underwent the End-of-Life Nursing Education Consortium training across 33 emergency departments. Data were extracted from the End-of-Life Nursing Education Consortium post-training questionnaire, comprising a 5-item survey and 1 open-ended question. Our quantitative analysis employed a cross-sectional design to assess the proportion of emergency nurses who report that they will encounter barriers in engaging seriously ill patients in serious illness conversations in the emergency department. Our qualitative analysis used conceptual content analysis to generate themes and meaning units of the perceived barriers and possible solutions toward having serious illness conversations in the emergency department. RESULTS: A total of 2176 emergency nurses responded to the survey. Results from the quantitative analysis showed that 1473 (67.7%) emergency nurses reported that they will encounter barriers while engaging in serious illness conversations. Three thematic barriers-human factors, time constraints, and challenges in the emergency department work environment-emerged from the content analysis. Some of the subthemes included the perceived difficulty of serious illness conversations, delay in daily throughput, and lack of privacy in the emergency department. The potential solutions extracted included the need for continued training, the provision of dedicated emergency nurses to handle serious illness conversations, and the creation of dedicated spaces for serious illness conversations. DISCUSSION: Emergency nurses may encounter barriers while engaging in serious illness conversations. Institutional-level policies may be required in creating a palliative care-friendly emergency department work environment.

Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department.

Background: The Functional Assessment of Cancer Therapy-General (FACT-G) is a widely used quality-of-life measure. However, no studies have examined the FACT-G among patients with life-limiting illnesses who present to emergency departments (EDs). Objective: The goal of this study was to examine the psychometric properties of the FACT-G among patients with life-limiting illnesses who present to EDs in the United States. Methods: This cross-sectional study pooled data from 12 EDs between April 2018 and January 2020 (n = 453). Patients enrolled in the study were adults with one or more of the four life-limiting illnesses: advanced cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, or End-Stage Renal Disease. We conducted item, exploratory, and confirmatory analyses (exploratory factor analysis [EFA] and confirmatory factor analysis [CFA]) to determine the psychometric properties of the FACT-G. Results: The FACT-G had good internal consistency (Cronbach's alpha α = 0.88). The simplest EFA model was a six-factor structure. The CFA supported the six-factor structure, evidenced by the adequate fit indices (comparative fit index = 0.93, Tucker-Lewis index = 0.92, root-mean-square error of approximation = 0.05; 90% confidence interval: 0.04 - 0.06). The six-factor structure comprised the physical, emotional, work and daily activities-related functional well-being, and the family and friends-related social well-being domains. Conclusions: The FACT-G is a reliable measure of health-related quality of life among patients with life-limiting illnesses who present to the ED. Clinical Trial Registration: NCT03325985.

Substance use and pre-hospital crash injury severity among U.S. older adults: A five-year national cross-sectional study.

BACKGROUND: Alcohol and drug use (substance use) is a risk factor for crash involvement. OBJECTIVES: To assess the association between substance use and crash injury severity among older adults and how the relationship differs by rurality/urbanicity. METHODS: We pooled 2017-2021 cross-sectional data from the United States National Emergency Medical Service (EMS) Information System. We measured injury severity (low acuity, emergent, critical, and fatal) predicted by substance use, defined as self-reported or officer-reported alcohol and/or drug use. We controlled for age, sex, race/ethnicity, road user type, anatomical injured region, roadway crash, rurality/urbanicity, time of the day, and EMS response time. We performed a partial proportional ordinal logistic regression and reported the odds of worse injury outcomes (emergent, critical, and fatal injuries) compared to low acuity injuries, and the predicted probabilities by rurality/urbanicity. RESULTS: Our sample consisted of 252,790 older adults (65 years and older) road users. Approximately 67%, 25%, 6%, and 1% sustained low acuity, emergent, critical, and fatal injuries, respectively. Substance use was reported in approximately 3% of the population, and this proportion did not significantly differ by rurality/urbanicity. After controlling for patient, crash, and injury characteristics, substance use was associated with 36% increased odds of worse injury severity. Compared to urban areas, the predicted probabilities of emergent, critical, and fatal injuries were higher in rural and suburban areas. CONCLUSION: Substance use is associated with worse older adult crash injury severity and the injury severity is higher in rural and suburban areas compared to urban areas.

Emergency Providers' Knowledge and Attitudes Toward Hospice and Palliative Care: A Cross-Sectional Analysis Across 35 Emergency Departments in the United States.

Background: Emergency providers' knowledge and attitudes may be a barrier to adopting hospice and palliative care practice. Objective: To assess provider characteristics associated with knowledge and attitudes toward hospice and palliative care (KAHP). Design: Cross-sectional analysis. Setting/Subjects: Emergency physicians, advanced practice providers (APPs), and nurses from 35 U.S. emergency departments (EDs) enrolled in a provider-focused intervention. Measurement: The outcome measures were the total and subscale scores of the KAHP scale. The predictor variables were age, sex, race/ethnicity, and years of practice. We reported the observed association using a linear mixed-effects regression model. Results: The mean KAHP score, rated from 10 to 50, was 36. Increased years of practice were associated with increased mean self-reported knowledge and attitudes scores among APPs and nurses. Conclusion: Understanding the provider characteristics associated with hospice and palliative care adoption in the ED may inform the development of interventions for specific providers. ClinicalTrials.gov (NCT03424109).

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Engagement, Advance Care Planning, and Hospice Use in a Telephonic Nurse-Led Palliative Care Program for Persons Living with Advanced Cancer.

Persons living with advanced cancer have intensive symptoms and psychosocial needs that often result in visits to the Emergency Department (ED). We report on program engagement, advance care planning (ACP), and hospice use for a 6-month longitudinal nurse-led, telephonic palliative care intervention for patients with advanced cancer as part of a larger randomized trial. Patients 50 years and older with metastatic solid tumors were recruited from 18 EDs and randomized to receive nursing calls focused on ACP, symptom management, and care coordination or specialty outpatient palliative care (ClinicialTrials.gov: NCT03325985). One hundred and five (50%) graduated from the 6-month program, 54 (26%) died or enrolled in hospice, 40 (19%) were lost to follow-up, and 19 (9%) withdrew prior to program completion. In a Cox proportional hazard regression, withdrawn subjects were more likely to be white and have a low symptom burden compared to those who did not withdraw. Two hundred eighteen persons living with advanced cancer were enrolled in the nursing arm, and 182 of those (83%) completed some ACP. Of the subjects who died, 43/54 (80%) enrolled in hospice. Our program demonstrated high rates of engagement, ACP, and hospice enrollment. Enrolling subjects with a high symptom burden may result in even greater program engagement.

Serious Illness Communication Skills Training for Emergency Physicians and Advanced Practice Providers: A Multi-Method Assessment of the Reach and Effectiveness of the Intervention.

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 is one of the components of Primary Palliative Care for Emergency Medicine (EM) intervention. It consisted of one 4-hour 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 63-100%. 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 discussion tips and tricks, improved attitude toward engaging qualifying patients in serious illness (SI) conversations, and commitment to using these learned skills in clinical practice. Conclusion: Effectively engaging qualifying patients in serious illness conversations requires appropriate communication skills. EM Talk has the potential to improve emergency providers' knowledge, attitude, and practice of SI communication skills. Trial registration: NCT03424109.

Knowledge and Attitudes Toward Hospice and Palliative Care: Instrument Validation Among Emergency Providers.

Background: Emergency providers can engage in goals of care discussions and hospice and palliative care referrals. Little is known about their knowledge and attitudes, which may influence these care practices. Objective: This study aims to re-validate the knowledge and attitude towards hospice and palliative care (KAHP) scale and assess the scale's latent constructs among emergency providers. Methods: The scale consists of ten items measured on a five-point Likert scale. Five of the ten items were reverse scored. Content validation was performed by ten experts in Hospice and Palliative Medicine and Emergency Medicine. Baseline surveys of emergency physicians, advance practice providers, and nurses conducted in the context of a pragmatic, randomized control trial were used for the item analysis and the exploratory and confirmatory factor analyses. Results: The KAHP scale is a ten-item scale scored from 10 to 50. Based on the synthesis of content validation results and the item analysis, all ten items were retained. The item and scale Content Validity Index were each .91. The reliability of the scale was .64 and the exploratory factor analysis identified three underlying constructs defined as self-rated knowledge, support for hospice and palliative care practice, and views on provider-patient communication. The presence of good model fit indices supported the structural integrity of the constructs. Conclusion: We present a validated instrument that is suitable for assessing knowledge and attitude variations toward interventions designed to improve hospice and palliative care practice among emergency providers.

Palliative care models for patients living with advanced cancer: a narrative review for the emergency department clinician.

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.

Emergency provider perspectives on facilitators and barriers to home and community services for older adults with serious life limiting illness: A qualitative study.

BACKGROUND: Older adults account for a large proportion of emergency department visits, but those with serious life-limiting illness may benefit most from referral to home and community services instead of hospitalization. We aim to document emergency provider perspectives on facilitators and barriers to accessing home and community services for older adults with serious life-limiting illness. METHODS: We conducted interviewer-administered semi-structured interviews with emergency providers from health systems across the United States to obtain provider perspectives on facilitators and barriers to accessing home and community services. We completed qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize provider responses. RESULTS: We interviewed 8 emergency nurses and 10 emergency physicians across 11 health systems. Emergency providers were familiar with local home and community services. Facilitators to accessing these services include care management and social workers. Barriers include services that are not accessible full-time to receive referrals, insurance/payment, and the busy nature of the emergency department. The most helpful reported services were hospice, physical therapy, occupational therapy, and visiting nursing services. Home-based palliative care and full-time emergency department-based care management and social work were the services most desired by providers. Providers expressed support for improving access to home and community services in the hopes of decreasing unnecessary emergency visits and inpatient admissions, and to provide patients with greater options for supportive care. CONCLUSION: Obtaining the perspective of emergency providers highlights important considerations to accessing HCS for older-adults with serious life-limiting illness from the emergency department. This study provides foundational information for futures studies and initiatives for improving access to home and community services directly from the emergency department.

Characterization of older adults with cancer seeking acute emergency department care: A prospective observational study.

INTRODUCTION: Disparities in care of older adults in cancer treatment trials and emergency department (ED) use exist. This report provides a baseline description of older adults ≥65 years old who present to the ED with active cancer. MATERIALS AND METHODS: Planned secondary analysis of the Comprehensive Oncologic Emergencies Research Network observational ED cohort study sponsored by the National Cancer Institute. Of 1564 eligible adults with active cancer, 1075 patients were prospectively enrolled, of which 505 were ≥ 65 years old. We recruited this convenience sample from eighteen participating sites across the United States between February 1, 2016 and January 30, 2017. RESULTS: Compared to cancer patients younger than 65 years of age, older adults were more likely to be transported to the ED by emergency medical services, have a higher Charlson Comorbidity Index score, and be admitted despite no significant difference in acuity as measured by the Emergency Severity Index. Despite the higher admission rate, no significant difference was noted in hospitalization length of stay, 30-day mortality, ED revisit or hospital admission within 30 days after the index visit. Three of the top five ED diagnoses for older adults were symptom-related (fever of other and unknown origin, abdominal and pelvic pain, and pain in throat and chest). Despite this, older adults were less likely to report symptoms and less likely to receive symptomatic treatment for pain and nausea than the younger comparison group. Both younger and older adults reported a higher symptom burden on the patient reported Condensed Memorial Symptom Assessment Scale than to ED providers. When treating suspected infection, no differences were noted in regard to administration of antibiotics in the ED, admissions, or length of stay ≤2 days for those receiving ED antibiotics. DISCUSSION: We identified several differences between older (≥65 years old) and younger adults with active cancer seeking emergency care. Older adults frequently presented for symptom-related diagnoses but received fewer symptomatic interventions in the ED suggesting that important opportunities to improve the care of older adults with cancer in the ED exist.

Palliative Care Needs and Clinical Outcomes of Patients with Advanced Cancer in the Emergency Department.

Background: Older adults with cancer use the emergency department (ED) for acute concerns. Objectives: Characterize the palliative care needs and clinical outcomes of advanced cancer patients in the ED. Design: A planned secondary data analysis of the Comprehensive Oncologic Emergencies Research Network (CONCERN) data. Settings/Subjects: Cancer patients who presented to the 18 CONCERN affiliated EDs in the United States. Measurements: Survey included demographics, cancer type, functional status, symptom burden, palliative and hospice care enrollment, and advance directive code status. Results: Of the total (674/1075, 62.3%) patients had advanced cancer and most were White (78.6%) and female (50.3%); median age was 64 (interquartile range 54-71) years. A small proportion of them were receiving palliative (6.5% [95% confidence interval; CI 3.0-7.6]; p = 0.005) and hospice (1.3% [95% CI 1.0-3.2]; p = 0.52) care and had a higher 30-day mortality rate (8.3%, [95% CI 6.2-10.4]). Conclusions: Patients with advanced cancer continue to present to the ED despite recommendations for early delivery of palliative care.

Emergency and post-emergency care of older adults with Alzheimer's disease/Alzheimer's disease related dementias.

BACKGROUND: The emergency department (ED) is a critical juncture in the care of persons living with dementia (PLwD), as they have a high rate of hospital admission, ED revisits, and subsequent inpatient stays. We examine ED disposition of PLwD compared with older adults with non-dementia chronic disease as well as healthcare utilization and survival. METHODS: Medicare claims data were used to identify community-dwelling older adults 66+ years old from 34 hospitals with either Alzheimer's disease/Alzheimer's disease related dementias (AD/ADRD) or a non-AD/ADRD chronic condition between January 1, 2014, and December 31, 2018. We compared ED disposition at the index visit, as well as healthcare utilization and mortality in the 12 months following an index ED visit, and adjusted for age, gender, and risk of mortality. RESULTS: There were 29,626 patients in the AD/ADRD sample, and 317,046 in the comparison sample. The AD/ADRD sample was older (82.4 years old [SD: 8.2] vs. 76.0 years old [SD: 7.7]) and had more female patients (59.9% vs. 54.7%). The AD/ADRD sample was more likely to experience ED disposition to acute care (OR 1.039, p < 0.001, 95% CI 1.029-1.050), to have an ED revisit (OR 1.077, p < 0.001, 95% CI 1.066-1.087), and an inpatient stay in the subsequent 12 months (OR 1.085, p < 0.001, 95% CI 1.075-1.095). ED disposition to hospice was low in both samples (0.2%). AD/ADRD patients had a higher risk of mortality (OR 1.099, p < 0.001, 95% CI 1.091-1.107) and high short-term mortality (31.9% within 12 months) than those without AD/ADRD (15.3% within 12 months). CONCLUSIONS: PLwD who visit the ED have high short-term mortality. Despite this, disposition to acute care, ED revisits, and inpatient stays, rather than hospice, remain the predominant mode of care delivery. Transition directly from the ED to hospice for PLwD is rare.

Mapping the future for research in emergency medicine palliative care: A research roadmap.

BACKGROUND: The intersection of emergency medicine (EM) and palliative care (PC) has been recognized as an essential area of focus, with evidence suggesting that increased integration improves outcomes. This has resulted in increased research in EM PC. No current framework exists to help guide investigation and innovation. OBJECTIVE: The objective was to convene a working group to develop a roadmap that would help provide focus and prioritization for future research. METHODS: Participants were identified based on clinical, operation, policy, and research expertise in both EM and PC and spanned physician, nursing, social work, and patient perspectives. The research roadmap setting process consisted of three distinct phases that were time staggered over 12 months and facilitated through three live video convenings, asynchronous input via an online document, and a series of smaller video convenings of work groups focused on specific topics. RESULTS: Gaps in the literature were identified and informed the four key areas for future research. Consensus was reached on these domains and the associated research questions in each domain to help guide future study. The key domains included work focused on the value imperative for PC in the emergency setting, models of care delivery, disparities, and measurement of impact and efficacy. Additionally, the group identified key methodological considerations for doing work at the intersection of EM and PC. CONCLUSIONS: There are several key domains and associated questions that can help guide future research in ED PC. Focus on these areas, and answering these questions, offers the potential to improve the emergency care of patients with PC needs.

Pragmatic clinical trial design in emergency medicine: Study considerations and design types.

Pragmatic clinical trials (PCTs) focus on correlation between treatment and outcomes in real-world clinical practice, yet a guide highlighting key study considerations and design types for emergency medicine investigators pursuing this important study type is not available. Investigators conducting emergency department (ED)-based PCTs face multiple decisions within the planning phase to ensure robust and meaningful study findings. The PRagmatic Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool allows trialists to consider both pragmatic and explanatory components across nine domains, shaping the trial design to the purpose intended by the investigators. Aside from the PRECIS-2 tool domains, ED-based investigators conducting PCTs should also consider randomization techniques, human subjects concerns, and integration of trial components within the electronic health record. The authors additionally highlight the advantages, disadvantages, and rationale for the use of four common randomized study design types to be considered in PCTs: parallel, crossover, factorial, and stepped-wedge. With increasing emphasis on the conduct of PCTs, emergency medicine investigators will benefit from a rigorous approach to clinical trial design.

Providing Hearing Assistance to Veterans in the Emergency Department: A Qualitative Study.

INTRODUCTION: Effective communication is essential to good health care, and hearing loss disrupts patient-provider communication. For the more than 2 million veterans with severe hearing loss, communication is particularly challenging in noisy health care environments such as emergency departments. The purpose of this qualitative study was to describe patient and provider perspectives of feasibility and potential benefit of providing a hearing assistance device, a personal amplifier, during visits to an emergency department in an urban setting affiliated with the Department of Veterans Affairs. METHODS: This qualitative descriptive study was conducted in parallel with a randomized controlled study. We completed a semistructured interview with 11 veterans and 10 health care providers to elicit their previous experiences with patient-provider communication in the ED setting and their perspectives on hearing screening and using the personal amplifier in the emergency department. Interview data were analyzed using content analysis and Atlas.ti V8.4 software (Scientific Software Development GmbH, Berlin, Germany). RESULTS: The veteran sample (n = 11) had a mean age of 80.3 years (SD = 10.2). The provider sample included 7 nurses and 3 physicians. In the ED setting, hearing loss disrupts patient-provider communication. Screening for hearing loss in the emergency department was feasible except in urgent/emergent cases. The use of the personal amplifier made communication more effective and less effortful for both veterans and providers. DISCUSSION: Providing the personal amplifier improved the ED experience for veterans and offers a promising intervention that could improve health care quality and safety for ED patient populations.