Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial.

Importance: More than 80% of patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. With more than 1 million annual hospitalizations for AHF in the US, safe and effective alternatives are needed. Care for AHF in short-stay units (SSUs) may be safe and more efficient than hospitalization, especially for lower-risk patients, but randomized clinical trial data are lacking. Objective: To compare the effectiveness of SSU care vs hospitalization in lower-risk patients with AHF. Design, Setting, and Participants: This multicenter randomized clinical trial randomly assigned low-risk patients with AHF 1:1 to SSU or hospital admission from the ED. Patients received follow-up at 30 and 90 days post discharge. The study began December 6, 2017, and was completed on July 22, 2021. The data were analyzed between March 27, 2020, and November 11, 2023. Intervention: Randomized post-ED disposition to less than 24 hours of SSU care vs hospitalization. Main Outcomes and Measures: The study was designed to detect at least 1-day superiority for a primary outcome of days alive and out of hospital (DAOOH) at 30-day follow-up for 534 participants, with an allowance of 10% participant attrition. Due to the COVID-19 pandemic, enrollment was truncated at 194 participants. Before unmasking, the primary outcome was changed from DAOOH to an outcome with adequate statistical power: quality of life as measured by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 scores range from 0 to 100, with higher scores indicating better quality of life. Results: Of the 193 patients enrolled (1 was found ineligible after randomization), the mean (SD) age was 64.8 (14.8) years, 79 (40.9%) were women, and 114 (59.1%) were men. Baseline characteristics were balanced between arms. The mean (SD) KCCQ-12 summary score between the SSU and hospitalization arms at 30 days was 51.3 (25.7) vs 45.8 (23.8) points, respectively (P = .19). Participants in the SSU arm had 1.6 more DAOOH at 30-day follow-up than those in the hospitalization arm (median [IQR], 26.9 [24.4-28.8] vs 25.4 [22.0-27.7] days; P = .02). Adverse events were uncommon and similar in both arms. Conclusions and Relevance: The findings show that the SSU strategy was no different than hospitalization with regard to KCCQ-12 score, superior for more DAOOH, and safe for lower-risk patients with AHF. These findings of lower health care utilization with the SSU strategy need to be definitively tested in an adequately powered study. Trial Registration: ClinicalTrials.gov Identifier: NCT03302910.

The association between specific narrative elements and patient perspectives on acute pain treatment.

BACKGROUND: Narratives are effective tools for communicating with patients about opioid prescribing for acute pain and improving patient satisfaction with pain management. It remains unclear, however, whether specific narrative elements may be particularly effective at influencing patient perspectives. METHODS: This study was a secondary analysis of data collected for Life STORRIED, a multicenter RCT. Participants included 433 patients between 18 and 70 years-old presenting to the emergency department (ED) with renal colic or musculoskeletal back pain. Participants were instructed to view one or more narrative videos during their ED visit in which a patient storyteller discussed their experiences with opioids. We examined associations between exposure to individual narrative features and patients' 1) preference for opioids, 2) recall of opioid-related risks and 3) perspectives about the care they received. RESULTS: Participants were more likely to watch videos featuring storytellers who shared their race or gender. We found that participants who watched videos that contained specific narrative elements, for example mention of prescribed opioids, were more likely to recall having received information about pain treatment options on the day after discharge (86.3% versus 72.9%, p = 0.02). Participants who watched a video that discussed family history of addiction reported more participation in their treatment decision than those who did not (7.6 versus 6.8 on a ten-point scale, p = 0.04). CONCLUSIONS: Participants preferentially view narratives featuring storytellers who share their race or gender. Narrative elements were not meaningfully associated with patient-centered outcomes. These findings have implications for the design of narrative communication tools.

Personalized risk communication and opioid prescribing in association with nonprescribed opioid use: A secondary analysis of a randomized controlled trial.

BACKGROUND: To determine the impact of personalized risk communication and opioid prescribing on nonprescribed opioid use, we conducted a secondary analysis of randomized controlled trial participants followed prospectively for 90 days after an emergency department (ED) visit for acute back or kidney stone pain. METHODS: A total of 1301 individuals were randomized during an encounter at four academic EDs into a probabilistic risk tool (PRT) arm, a narrative-enhanced PRT arm, or a general risk information arm (control). In this secondary analysis, both risk tool arms were combined and compared with the control arm. We used logistic regressions to determine associations between receiving personalized risk information, receiving an opioid prescription in the ED, and nonprescribed opioid use in general and by race. RESULTS: Complete follow-up data were available for 851 participants; 23.3% (n = 198) were prescribed opioids (34.2% of White vs. 11.6% of Black participants, p < 0.001). Fifty-six (6.6%) participants used nonprescribed opioids. Participants in the personalized risk communication arms had lower nonprescribed opioid use odds (adjusted odds ratio [aOR] 0.58, 95% confidence interval [CI] 0.4-0.83). Black versus White participants had greater nonprescribed opioid use odds (aOR 3.47, 95% CI 2.05-5.87, p < 0.001). Black participants who were prescribed opioids had a lower marginal probability of using nonprescribed opioids versus those who were not (0.06, 95% CI 0.04-0.08, p < 0.001 vs. 0.10, 95% CI 0.08-0.11, p < 0.001). The absolute risk difference in nonprescribed opioid use for Black and White participants, respectively, in the risk communication versus the control arm, was 9.7% and 0.1% (relative risk ratio 0.43 vs. 0.95). CONCLUSIONS: Among Black but not White participants, personalized opioid risk communication and opioid prescribing were associated with lower odds of nonprescribed opioid use. Our findings suggest that racial disparities in opioid prescribing-which have been previously described within the context of this trial-may paradoxically increase nonprescribed opioid use. Personalized risk communication may effectively reduce nonprescribed opioid use, and future research should be designed specifically to explore this possibility in a larger cohort.

User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial.

OBJECTIVE: To determine the effect of a user centered clinical decision support tool versus usual care on rates of initiation of buprenorphine in the routine emergency care of individuals with opioid use disorder. DESIGN: Pragmatic cluster randomized controlled trial (EMBED). SETTING: 18 emergency department clusters across five healthcare systems in five states representing the north east, south east, and western regions of the US, ranging from community hospitals to tertiary care centers, using either the Epic or Cerner electronic health record platform. PARTICIPANTS: 599 attending emergency physicians caring for 5047 adult patients presenting with opioid use disorder. INTERVENTION: A user centered, physician facing clinical decision support system seamlessly integrated into user workflows in the electronic health record to support initiating buprenorphine in the emergency department by helping clinicians to diagnose opioid use disorder, assess the severity of withdrawal, motivate patients to accept treatment, and complete electronic health record tasks by automating clinical and after visit documentation, order entry, prescribing, and referral. MAIN OUTCOME MEASURES: Rate of initiation of buprenorphine (administration or prescription of buprenorphine) in the emergency department among patients with opioid use disorder. Secondary implementation outcomes were measured with the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. RESULTS: 1 413 693 visits to the emergency department (775 873 in the intervention arm and 637 820 in the usual care arm) from November 2019 to May 2021 were assessed for eligibility, resulting in 5047 patients with opioid use disorder (2787 intervention arm, 2260 usual care arm) under the care of 599 attending physicians (340 intervention arm, 259 usual care arm) for analysis. Buprenorphine was initiated in 347 (12.5%) patients in the intervention arm and in 271 (12.0%) patients in the usual care arm (adjusted generalized estimating equations odds ratio 1.22, 95% confidence interval 0.61 to 2.43, P=0.58). Buprenorphine was initiated at least once by 151 (44.4%) physicians in the intervention arm and by 88 (34.0%) in the usual care arm (1.83, 1.16 to 2.89, P=0.01). CONCLUSIONS: User centered clinical decision support did not increase patient level rates of initiating buprenorphine in the emergency department. Although streamlining and automating electronic health record workflows can potentially increase adoption of complex, unfamiliar evidence based practices, more interventions are needed to look at other barriers to the treatment of addiction and increase the rate of initiating buprenorphine in the emergency department in patients with opioid use disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658642.

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions. Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient's estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence. Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p<0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups. Conclusion: The AMI Choice conversation tool improved patients' knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence. Trial Registration Number: NCT00888537.

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.

A Multicentered Randomized Controlled Trial Comparing the Effectiveness of Pain Treatment Communication Tools in Emergency Department Patients With Back or Kidney Stone Pain.

Objectives. To compare the effectiveness of 3 approaches for communicating opioid risk during an emergency department visit for a common painful condition. Methods. This parallel, multicenter randomized controlled trial was conducted at 6 geographically disparate emergency department sites in the United States. Participants included adult patients between 18 and 70 years of age presenting with kidney stone or musculoskeletal back pain. Participants were randomly assigned to 1 of 3 risk communication strategies: (1) a personalized probabilistic risk visual aid, (2) a visual aid and a video narrative, or 3) general risk information. The primary outcomes were accuracy of risk recall, reported opioid use, and treatment preference at time of discharge. Results. A total of 1301 participants were enrolled between June 2017 and August 2019. There was no difference in risk recall at 14 days between the narrative and probabilistic groups (43.7% vs 38.8%; absolute risk reduction = 4.9%; 95% confidence interval [CI] = -2.98, 12.75). The narrative group had lower rates of preference for opioids at discharge than the general risk information group (25.9% vs 33.0%; difference = 7.1%; 95% CI = 0.64, 0.97). There were no differences in reported opioid use at 14 days between the narrative, probabilistic, and general risk groups (10.5%, 10.3%, and 13.3%, respectively; P = .44). Conclusions. An emergency medicine communication tool incorporating probabilistic risk and patient narratives was more effective than general information in mitigating preferences for opioids in the treatment of pain but was not more effective with respect to opioid use or risk recall. Trial Registration. Clinical Trials.gov identifier: NCT03134092. (Am J Public Health. 2022;112(S1):S45-S55. https://doi.org/10.2105/AJPH.2021.306511).

Clinicians' perspectives on the implementation of patient decision aids in the emergency department: A qualitative interview study.

OBJECTIVE: Decision aids (DAs) are tools to facilitate and standardize shared decision making (SDM). Although most emergency clinicians (ECs) perceive SDM appropriate for emergency care, there is limited uptake of DAs in clinical practice. The objective of this study was to explore barriers and facilitators identified by ECs regarding the implementation of DAs in the emergency department (ED). METHODS: We conducted a qualitative interview study guided by implementation science frameworks. ECs participated in interviews focused on the implementation of DAs for the disposition of patients with low-risk chest pain and unexplained syncope in the ED. Interviews were recorded and transcribed verbatim. We then iteratively developed a codebook with directed qualitative content analysis. RESULTS: We approached 25 ECs working in urban New York, of whom 20 agreed to be interviewed (mean age, 41 years; 25% women). The following 6 main barriers were identified: (1) poor DA accessibility, (2) concern for increased medicolegal risk, (3) lack of perceived need for a DA, (4) patient factors including lack of capacity and limited health literacy, (5) skepticism about validity of DAs, and (6) lack of time to use DAs. The 6 main facilitators identified were (1) positive attitudes toward SDM, (2) patient access to follow-up care, (3) potential for improved patient satisfaction, (4) potential for improved risk communication, (5) strategic integration of DAs into the clinical workflow, and (6) institutional support of DAs. CONCLUSIONS: ECs identified multiple barriers and facilitators to the implementation of DAs into clinical practice. These findings could guide implementation efforts targeting the uptake of DA use in the ED.

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: This clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients. METHODS: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing randomized and nonrandomized trials, observational studies, registries, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. STRUCTURE: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated, and shared decision-making with patients is recommended.

Trauma Communications Center Coordinated Severity-Based Stroke Triage: Protocol of a Hybrid Type 1 Effectiveness-Implementation Study.

Background: Mechanical thrombectomy (MT) can improve the outcomes of patients with large vessel occlusion (LVO), but a minority of patients with LVO are treated and there are disparities in timely access to MT. In part, this is because in most regions, including Alabama, the emergency medical service (EMS) transports all patients with suspected stroke, regardless of severity, to the nearest stroke center. Consequently, patients with LVO may experience delayed arrival at stroke centers with MT capability and worse outcomes. Alabama's trauma communications center (TCC) coordinates EMS transport of trauma patients by trauma severity and regional hospital capability. Our aims are to develop a severity-based stroke triage (SBST) care model based on Alabama's trauma system, compare the effectiveness of this care pathway to current stroke triage in Alabama for improving broad, equitable, and timely access to MT, and explore stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability. Methods: This is a hybrid type 1 effectiveness-implementation study with a multi-phase mixed methods sequential design and an embedded observational stepped wedge cluster trial. We will extend TCC guided stroke severity assessment to all EMS regions in Alabama; conduct stakeholder interviews and focus groups to aid in development of region and hospital specific prehospital and inter-facility stroke triage plans for patients with suspected LVO; implement a phased rollout of TCC Coordinated SBST across Alabama's six EMS regions; and conduct stakeholder surveys and interviews to assess context-specific perceptions of the intervention. The primary outcome is the change in proportion of prehospital stroke system patients with suspected LVO who are treated with MT before and after implementation of TCC Coordinated SBST. Secondary outcomes include change in broad public health impact before and after implementation and stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability using a mixed methods approach. With 1200 to 1300 total observations over 36 months, we have 80% power to detect a 15% improvement in the primary endpoint. Discussion: This project, if successful, can demonstrate how the trauma system infrastructure can serve as the basis for a more integrated and effective system of emergency stroke care.

Paths of Emergency Department Care: Development of a Decision Aid to Facilitate Shared Decision Making in Goals of Care Discussions in the Acute Setting.

BACKGROUND: Goals of care (GOC) conversations in the emergency department (ED) are often a brief discussion of code status rather than a patient-oriented dialogue. We aimed to develop a guide to facilitate conversations between ED clinicians and patients to elicit patient values and establish goals for end-of-life care, while maintaining ED efficiency. Paths of ED Care, a conversation guide, is the product of this work. DESIGN: A multidisciplinary/multispecialty group used recommended practices to adapt a GOC conversation guide for ED patients. ED clinicians used the guide and provided feedback on content, design, and usability. Patient-clinician interactions were recorded for discussion analysis, and both were surveyed to inform iterative refinement. A series of discussions with patient representatives, multidisciplinary clinicians, bioethicists, and health care designers yielded feedback. We used a process similar to the International Patient Decision Aid Standards and provide comparison to these. RESULTS: A conversation guide, eight pages with each page 6 by 6 inches in dimension, uses patient-oriented prompts and includes seven sections: 1) evaluation of patient/family understanding of disease, 2) explanation of possible trajectories, 3) introduction to different pathways of care, 4) explanation of pathways, 5) assessment of understanding and concerns, 6) code status, and 7) personalized summary. LIMITATIONS: Recruitment of sufficient number of patients/providers to the project was the primary limitation. Methods are limited to qualitative analysis of guide creation and feasibility without quantitative analysis. CONCLUSIONS: Paths of ED Care is a guide to facilitate patient-centered shared decision making for ED patients, families, and clinicians regarding GOC. This may ensure care concordant with patients' values and preferences. Use of the guide was well-received and facilitated meaningful conversations between patients and providers.

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: This executive summary of the clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients. METHODS: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. STRUCTURE: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. These guidelines present an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated and shared decision-making with patients is recommended.

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: This clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients. METHODS: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing randomized and nonrandomized trials, observational studies, registries, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. STRUCTURE: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated, and shared decision-making with patients is recommended.

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: This clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients. METHODS: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing randomized and nonrandomized trials, observational studies, registries, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. Structure: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated, and shared decision-making with patients is recommended.