Dataset Information

In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.

ABSTRACT: INTRODUCTION:Multicenter clinical trials of high-acuity, low-frequency emergencies are expensive and resource intensive. Current standards for trial preparation have significant limitations. Our objective is to describe our use of in situ simulation (ISS) to identify and mitigate threats to enrollment, protocol adherence, and patient safety in preparation for a multicenter clinical trial of antiepileptics for status epilepticus in the emergency department. METHODS:This is a descriptive study of ISS conducted in the emergency department at a free-standing, academic pediatric institution. We designed two scenarios, one for an eligible and ineligible patient, to allow care teams to complete all study procedures. All study training was completed before the first ISS. Participants included physicians, nurses, patient care assistants, paramedics, research coordinators, and pharmacists. Ten-minute simulations were followed by 10-minute debriefings, led by trained facilitators using a standard template. Data on threats to enrollment, protocol adherence, and patient safety were recorded. Mitigation strategies were developed by the study team and local experts in ISS. RESULTS:Ten of 18 planned simulations were conducted. Seven of 10 completed simulations were study eligible patients, with 73 total participants. Nine threats to enrollment and five to protocol adherence were identified. Five of 14 were also threats to patient safety. Mitigation strategies included creation of decision aid tools, targeted education during debriefings, adapting study material for use, and revision of status epilepticus treatment algorithm. CONCLUSIONS:The addition of ISS to standard preparation for a multicenter clinical trial facilitated the identification and mitigation of threats to study participation and patient safety.

SUBMITTER: Chan S

PROVIDER: S-EPMC6358461 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.

Chan Steven S Babcock Lynn L Geis Gary G Frey Mary M Robinson Venita V Kerrey Benjamin B

Simulation in healthcare : journal of the Society for Simulation in Healthcare 20190201 1

<h4>Introduction</h4>Multicenter clinical trials of high-acuity, low-frequency emergencies are expensive and resource intensive. Current standards for trial preparation have significant limitations. Our objective is to describe our use of in situ simulation (ISS) to identify and mitigate threats to enrollment, protocol adherence, and patient safety in preparation for a multicenter clinical trial of antiepileptics for status epilepticus in the emergency department.<h4>Methods</h4>This is a descri ...[more]

PMID: 30216275

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Project description:BACKGROUND:Given system-level focus on avoidance of unnecessary hospitalizations, better understanding admission decision-making is of utility. Our study sought to identify factors associated with hospital admission versus discharge from the Emergency Department (ED) for a population of patients who were assessed as having low medical acuity at time of decision. METHODS:Using an institutional database, we identified ED admission requests received from March 1, 2018 to Feb 28, 2019 that were assessed by a physician at the time of request as potentially inappropriate based on lack of medical acuity. Focused chart review was performed to extract data related to patient demographics, socioeconomic information, measures of illness, and system-level factors such as previous healthcare utilization and day/time of presentation. A binary logistic regression model was constructed to correlate patient and system factors with disposition outcome of admission to the hospital versus discharge from the ED. Physician-reported contributors to admission decision-making and chief complaint/reason for admission were summarized. RESULTS:A total of 349 (77.2%) of 452 calls resulted in admission to the hospital and 103 (22.8%) resulted in discharge from the ED. Predictors of admission included age over 65 (OR 3.5 [95%CI 1.1-11.6], p?=?0.039), homelessness (OR 3.3 [95% CI 1.7-6.4], p=0.001), and night/weekend presentation (OR 2.0 [95%CI 1.1-3.5], p?=?0.020). The most common contributing factors to the decision to admit reported by the responding physician included: lack of outpatient social support (35.8% of admissions), homelessness (33.0% of admissions), and substance use disorder (23.5% of admissions). CONCLUSIONS:Physician medical decision-making regarding the need for hospitalization incorporates consideration of individual patient characteristics, social setting, and system-level barriers. Interventions aimed at reducing unnecessary hospitalizations, especially those involving patients with low medical acuity, should focus on underlying unmet needs and involve a broad set of perspectives.

Project description:ObjectivesEmergency department (ED) resuscitation is a complex, high-stakes procedure where positive outcomes depend on effective interactions between the health care team, the patient, and the environment. Resuscitation teams work in dynamic environments and strive to ensure the timely delivery of necessary treatments, equipment, and skill sets when required. However, systemic failures in this environment cannot always be adequately anticipated, which exposes patients to opportunities for harm.MethodsAs part of a new interprofessional education and quality improvement initiative, this prospective, observational study sought to characterize latent safety threats (LSTs) identified during the delivery of in situ, simulated resuscitations in our ED. In situ simulation (ISS) sessions were delivered on a monthly basis in the EDs at each campus of a large tertiary care academic hospital system, during which a variety of scenarios were run with teams of ED health care professionals. LSTs were identified by simulation facilitators and participants during the case and debriefing and then grouped thematically for analysis.ResultsDuring the study period, 22 ISS sessions were delivered, involving 58 cases and reaching 383 ED health care professionals. 196 latent safety threats were identified through these sessions (mean = 3.4 LSTs per case) of which 110 were determined to be "actionable" at a system level. LSTs identified included system/environmental design flaws, equipment problems, failures in department processes, and knowledge/skill gaps. Corrective mechanisms were initiated in 85% of actionable cases.ConclusionsEffective quality improvement and continuing education programs are essential to translate these findings into more resilient patient care. ISS, beyond its role as a training tool for developing intrinsic and crisis resource management skills, can be effectively used to identify system issues in the ED that could expose critically ill patients to harm.

Dataset Information

In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.

Publications

In Situ Simulation to Mitigate Threats to Participation in a Multicenter Clinical Trial in High-Acuity, Low-Frequency Setting.

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