Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Due to the acuity and time-sensitive needs of their clinical condition, patients presenting with certain emergent pathologies may lack capacity to provide meaningful prospective informed consent to participate in clinical research. For these reasons, these populations have often been excluded from research investigations. To mitigate this, regulations allowing exception from informed consent (EFIC; 21 CFR 50.24) or waiver of informed consent (WIC; 45 CFR 46.101) were developed in 1996. The purpose of this study was to identify trends in the utilization of EFIC and WIC in emergency research. We also sought to describe the disclosure of necessary prestudy regulatory requirements and justification for the use of EFIC/WIC as reported in completed EFIC/WIC clinical trials. ⋯ Since their implementation in 1996, the EFIC/WIC regulations have allowed progress in research aimed at determining optimal care for devastating life-threatening conditions. However, consistent and rigorous report of regulatory prestudy requirements and justification of the use of EFIC/WIC is lacking in clinical trial publications or on websites such as ClinicalTrials.gov. Since research without consent is an ethically sensitive issue and not widely understood, better justification of its needs within the presentation of the research itself may educate the general medical community and also reduce concerns about whether or not the regulations are being properly applied.
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Multicenter Study
Patient Preferences Regarding Shared Decision Making in the Emergency Department: Findings From a Multisite Survey.
As shared decision making (SDM) has received increased attention as a method to improve the patient-centeredness of emergency department (ED) care, we sought to determine patients' desired level of involvement in medical decisions and their perceptions of potential barriers and facilitators to SDM in the ED. ⋯ We found that the majority of ED patients in our large, diverse sample wanted to be involved in medical decisions, especially in the case of a "serious" medical problem, and felt that they had the ability to do so. Nevertheless, many patients were unlikely to actively seek involvement and defaulted to allowing the physician to make decisions during the ED visit. After fully explaining the consequences of a decision, clinicians should make an effort to explicitly ascertain patients' desired level of involvement in decision making.
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Randomized Controlled Trial
Factors Associated With Patient Involvement in Emergency Care Decisions: A Secondary Analysis of the Chest Pain Choice Multicenter Randomized Trial.
Shared decision making in the emergency department (ED) can increase patient engagement for patients presenting with chest pain. However, little is known regarding which factors are associated with actual patient involvement in decision making or patients' desired involvement in emergency care decisions. We examined which factors were associated with patients' actual and desired involvement in decision making among ED chest pain patients. ⋯ Patients' reported desire for involvement in decision making was higher among those with higher health literacy. After study site and other potential confounding factors were adjusted for, only use of the decision aid was associated with observed patient involvement in decision making. As the science and practice of shared decision making in the ED moves toward implementation, high-fidelity integration of the decision aid into the flow of care will be necessary to realize desired outcomes.
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With the rise of opioid use in the United States, the increasing demand for treatment for opioid use disorders presents both a challenge and an opportunity to develop new care pathways for emergency department (ED) patients seeking opioid detoxification. We set out to improve the care of patients presenting to our ED seeking opioid detoxification by implementing a standardized management pathway and to measure the effects of this intervention. ⋯ Implementation of an opioid detoxification management pathway reduced EDLOS, reduced utilization of resources, and increased the proportion of patients prescribed medications for symptom relief.