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.

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 Department Communication in Persons Living With Dementia and Care Partners: A Scoping Review.

OBJECTIVES: To synthesize published research exploring emergency department (ED) communication strategies and decision-making with persons living with dementia (PLWD) and their care partners as the basis for a multistakeholder consensus conference to prioritize future research. DESIGN: Systematic scoping review. SETTINGS AND PARTICIPANTS: PLWD and their care partners in the ED setting. METHODS: Informed by 2 Patient-Intervention-Comparison-Outcome (PICO) questions, we conducted systematic electronic searches of medical research databases for relevant publications following standardized methodological guidelines. The results were presented to interdisciplinary stakeholders, including dementia researchers, clinicians, PLWD, care partners, and advocacy organizations. The PICO questions included: How does communication differ for PLWD compared with persons without dementia? Are there specific communication strategies that improve the outcomes of ED care? Future research areas were prioritized. RESULTS: From 5451 studies identified for PICO-1, 21 were abstracted. From 2687 studies identified for PICO-2, 3 were abstracted. None of the included studies directly evaluated communication differences between PLWD and other populations, nor the effectiveness of specific communication strategies. General themes emerging from the scoping review included perceptions by PLWD/care partners of rushed ED communication, often exacerbated by inconsistent messages between providers. Care partners consistently reported limited engagement in medical decision-making. In order, the research priorities identified included: (1) Barriers/facilitators of effective communication; (2) valid outcome measures of effective communication; (3) best practices for care partner engagement; (4) defining how individual-, provider-, and system-level factors influence communication; and (5) understanding how each member of ED team can ensure high-quality communication. CONCLUSIONS AND IMPLICATIONS: Research exploring ED communication with PLWD is sparse and does not directly evaluate specific communication strategies. Defining barriers and facilitators of effective communication was the highest-ranked research priority, followed by validating outcome measures associated with improved information exchange.

Developing a decision instrument to guide abdominal-pelvic imaging of blunt trauma patients: Methodology and protocol of the NEXUS abdominal-pelvic imaging study.

Although computed tomography (CT) of the abdomen and pelvis (A/P) can provide crucial information for managing blunt trauma patients, liberal and indiscriminant imaging is expensive, can delay critical interventions, and unnecessarily exposes patients to ionizing radiation. Currently no definitive recommendations exist detailing which adult blunt trauma patients should receive A/P CT imaging and which patients may safely forego CT. Considerable benefit could be realized by identifying clinical criteria that reliably classify the risk of abdominal and pelvic injuries in blunt trauma patients. Patients identified as "very low risk" by such criteria would be free of significant injury, receive no benefit from imaging and therefore could be safely spared the expense and radiation exposure associated with A/P CT. The goal of this two-phase nationwide multicenter observational study is to derive and validate the use of clinical criteria to stratify the risk of injuries to the abdomen and pelvis among adult blunt trauma patients. We estimate that nation-wide implementation of a rigorously developed decision instrument could safely reduce CT imaging of adult blunt trauma patients by more than 20%, and reduce annual radiographic charges by $180 million, while simultaneously expediting trauma care and decreasing radiation exposure with its attendant risk of radiation-induced malignancy. Prior to enrollment we convened an expert panel of trauma surgeons, radiologists and emergency medicine physicians to develop a consensus definition for clinically significant abdominal and pelvic injury. In the first derivation phase of the study, we will document the presence or absence of preselected candidate criteria, as well as the presence or absence of significant abdominal or pelvic injuries in a cohort of blunt trauma victims. Using recursive partitioning, we will examine combinations of these criteria to identify an optimal "very low risk" subset that identifies injuries with a sensitivity exceeding 98%, excludes injury with a negative predictive value (NPV) greater than 98%, and retains the highest possible specificity and potential to decrease imaging. In Phase 2 of the study we will validate the performance of a decision rule based on these criteria among a new cohort of patients to ensure that the criteria retain high sensitivity, NPV and optimal specificity. Validating the sensitivity of the decision instrument with high statistical precision requires evaluations on 317 blunt trauma patients who have significant abdominal-pelvic injuries, which will in turn require evaluations on approximately 6,340 blunt trauma patients. We will estimate potential reductions in CT imaging by counting the number of abdominal-pelvic CT scans performed on "very low risk" patients. Reductions in charges and radiation exposure will be determined by respectively summing radiographic charges and lifetime decreases in radiation morbidity and mortality for all "very low risk" cases. Trial registration: Clinicaltrials.gov trial registration number: NCT04937868.

United States Best Practice Guidelines for Primary Palliative Care in the Emergency Department.

The growing palliative care needs of emergency department (ED) patients in the United States have motivated the development of ED primary palliative care principles. An expert panel convened to develop best practice guidelines for ED primary palliative care to help guide frontline ED clinicians based on available evidence and consensus opinion of the panel. Results include recommendations for screening and assessment of palliative care needs, ED management of palliative care needs, goals of care conversations, ED palliative care and hospice consults, and transitions of care.

Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

Lessons From Learners: Adapting Medical Student Education During and Post COVID-19.

In response to the COVID-19 pandemic, many medical schools suspended clinical clerkships and implemented newly adapted curricula to facilitate continued educational progress. While the implementation of these new curricula has been described, an understanding of the impact on student learning outcomes is lacking. In 2020, the authors followed Kern's 6-step approach to curricular development to create and evaluate a novel COVID-19 curriculum for medical students at the University of California San Francisco School of Medicine and evaluate its learning outcomes. The primary goal of the curriculum was to provide third- and fourth-year medical students an opportunity for workplace learning in the absence of clinical clerkships, specifically for students to develop clerkship-level milestones in the competency domains of practice-based learning and improvement, professionalism, and systems-based practice. The curriculum was designed to match students with faculty-mentored projects occurring primarily in virtual formats. A total of 126 students enrolled in the curriculum and completed a survey about their learning outcomes (100% response rate). Of 35 possible clerkship-level milestones, there were 12 milestones for which over half of students reported development in competency domains including practice-based learning and improvement, professionalism, and interpersonal and communication skills. Thematic analysis of students' qualitative survey responses demonstrated 2 central motivations for participating in the curriculum: identity as physicians-in-training and patient engagement. Six central learning areas were developed during the curriculum: interprofessional teamwork, community resources, technology in medicine, skill-building, quality improvement, and specialty-specific learning. This analysis demonstrates that students can develop competencies and achieve rich workplace learning through project-based experiential learning, even in virtual clinical workplaces. Furthermore, knowledge of community resources, technology in medicine, and quality improvement was developed through the curriculum more readily than in traditional clerkships. These could be considered as integral learning objectives in future curricular design.

Sonographic Findings in Necrotizing Fasciitis: Two Ends of the Spectrum.

Necrotizing fasciitis is a rare but serious disease, and early diagnosis is essential to reducing its substantial morbidity and mortality. The 2 cases presented show that the key clinical and radiographic features of necrotizing fasciitis exist along a continuum of severity at initial presentation; thus, this diagnosis should not be prematurely ruled out in cases that do not show the dramatic features familiar to most clinicians. Although computed tomography and magnetic resonance imaging are considered the most effective imaging modalities, the cases described here illustrate how sonography should be recommended as an initial imaging test to make a rapid diagnosis and initiate therapy.

The violent or agitated patient.

Violent and agitated patients are high risk because they may pose a physical threat to the staff, may harm themselves, and may have dangerous comorbidities and illness that are causing the violence. The emergency physician must quickly control these behaviors, and thoroughly identify and treat their etiology, while simultaneously protecting the patients' rights and reducing the risks of injury to themselves, other patients, and medical staff. This article highlights potentially high-risk situations and describes corresponding mitigation tactics.

Structural visualization of polarization fatigue in epitaxial ferroelectric oxide devices.

Ferroelectric oxides, such as Pb(Zr,Ti)O(3), are useful for electronic and photonic devices because of their ability to retain two stable polarization states, which can form the basis for memory and logic circuitry. Requirements for long-term operation of practical devices such as non-volatile RAM (random access memory) include consistent polarization switching over many (more than 10(12)) cycles of the applied electric field, which represents a major challenge. As switching is largely controlled by the motion and pinning of domain walls, it is necessary to develop suitable tools that can directly probe the ferroelectric domain structures in operating devices-thin-film structures with electrical contacts. A recently developed synchrotron X-ray microdiffraction technique complements existing microscopic probes, and allows us to visualize directly the evolution of polarization domains in ferroelectric devices, through metal or oxide electrodes, and with submicrometre spatial resolution. The images reveal two regimes of fatigue, depending on the magnitude of the electric field pulses driving the device: a low-field regime in which fatigue can be reversed with higher electric field pulses, and a regime at very high electric fields in which there is a non-reversible crystallographic relaxation of the epitaxial ferroelectric film.