Resuscitation simulation among people who are likely to witness opioid overdose: Experiences from the SOONER Trial.
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SUBMITTER: Whittall JP
PROVIDER: S-EPMC9255733 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimWe plan to conduct a randomised clinical trial among people likely to witness opioid overdose to compare the educational effectiveness of point-of-care naloxone distribution with best-available care, by observing participants' resuscitation skills in a simulated overdose. This mixed methods feasibility study aims to assess the effectiveness of recruitment and retention strategies and acceptability of study procedures.MethodsWe implemented candidate-driven recruitment strategies with verbal consent and destigmatizing study materials in a family practice, emergency department, and addictions service. People ≥16 years of age who are likely to witness overdose were randomized to point-of-care naloxone distribution or referral to an existing program. We evaluated participant skills as a responder to a simulated overdose 3-14 days post-recruitment. Retention strategies included flexible scheduling, reminders, cash compensation and refreshments. The primary outcome was recruitment and retention feasibility, defined as the ability to recruit 28 eligible participants in 28 days, with <50% attrition at the outcome simulation. Acceptability of study procedures and motivations for participation were assessed in a semi-structured interview.ResultsWe enrolled 30 participants over 24 days, and retained 21 participants (70%, 95%CI 56.7-100). The most common motivation for participation was a desire to serve the community or loved ones in distress. Participants reported that study procedures were acceptable and that the outcome simulation provided a supportive and affirming environment.ConclusionThe planned trial is ready for implementation. Recruitment and retention is feasible and study processes are acceptable for people who are likely to witness overdose. (Registration: NCT03821649).
| S-EPMC8244470 | biostudies-literature
Project description:INTRODUCTION:The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial. METHODS AND ANALYSIS:Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2?weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered. ETHICS AND DISSEMINATION:The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov registry (NCT03821649).
| S-EPMC6858090 | biostudies-literature
Project description:IntroductionIn the context of an opioid public health crisis, U.S. medical schools have been called upon to strengthen curricula on the appropriate use of opioids, with an emphasis on maximizing benefits while utilizing risk-mitigation strategies to prevent addiction and overdose.MethodsThis self-contained module provides an overview of the opioid crisis and presents recent clinical guidelines on opioid risk mitigation, as well as information regarding prevention and treatment of opioid overdose. This module then gives learners the opportunity to practice these skills by solving an evolving case of back pain.ResultsVerbal and written feedback on the module from students revealed that the majority strongly agreed that, overall, the module was valuable as an educational tool.DiscussionThis module was created to help medical educators update the training of students in risk mitigation strategies and the steps of opioid overdose resuscitation. The feedback to date from students and faculty has been positive and supports its use in undergraduate medical education.
| S-EPMC6338191 | biostudies-literature
Project description:Introduction:Opioid abuse is a growing problem in the United States. As a result, emergency medicine physicians often use naloxone to reverse opioid overdoses. While normally a safe drug, one potential complication of the antidote's use is flash pulmonary edema. This simulation was created after a patient followed the clinical course described after an opioid overdose. Methods:This simulation utilized a high-fidelity simulator to expose resident emergency medicine physicians to flash pulmonary edema secondary to naloxone administration. The simulation involved a 31-year-old male patient presenting with agonal respirations following an opioid overdose. The residents managed the patient appropriately with naloxone. However, he developed progressive dyspnea. The residents soon discovered that the patient was in flash pulmonary edema. They managed his airway, provided mechanical ventilation, and considered extracorporeal membrane oxygenation. Results:When this simulation was run for emergency medicine residents at SUNY Upstate Medical University, the learners felt that it was highly useful, and that it expanded their knowledge in this field. Out of 17 learners, the average rating to the question of: "[This simulation] added to my understanding of key concepts and helped the session meet the objectives" was 4.6 on a 1-5 Likert scale. Discussion:This simulation is a practical method by which many institutions can help to further physician knowledge on opioid overdose complications. It is relatively straightforward to run, and the educational yield is high.
| S-EPMC6338199 | biostudies-other
Project description:BackgroundOpioid overdose (OD) and opioid OD death are major health threats to people with opioid use disorder (OUD). Socioeconomic factors are underexplored potential determinants of opioid OD. In this study, we assessed socioeconomic and other factors and their associations with incident and fatal opioid OD, in a cohort consisting of 22,079 individuals with OUD.MethodsWe performed a retrospective, longitudinal study based on Swedish national register data for the period January 2005-December 2017. We used Cox proportional hazard models to investigate the risk of incident and fatal opioid OD as a function of several individual, parental and neighborhood covariates.ResultsUnivariate analysis showed that several covariates were associated with incident and fatal opioid OD. In the multivariate analysis, incident opioid OD was associated with educational attainment (Hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.94-0.97), having received social welfare (HR 1.31; 95% CI 1.22-1.39), and criminal conviction (HR 1.53; 95% CI 1.42-1.65). Fatal opioid OD was also associated with criminal conviction (HR 1.93; 95% CI 1.61-2.32).ConclusionIndividuals with low education and receipt of social welfare had higher risks of incident opioid OD and individuals with criminal conviction were identified as a risk group for both incident and fatal opioid OD. Our findings should raise attention among health prevention policy makers in general, and among decision-makers within the criminal justice system and social services in particular.
| S-EPMC8474855 | biostudies-literature
Project description:BackgroundNonfatal opioid overdose (OD) is an opportunity to identify patients who may benefit from interventions to reduce repeated overdose (rOD). In this study, we sought to determine risk and protective factors associated with rOD.MethodsIn this retrospective cohort study of 4,155 patients aged 18-64 who presented to one of 16 emergency departments in a single Western Pennsylvania health system between July 2015 and January 2018 for index opioid overdose (iOD) and survived to discharge, we identified demographic and clinical factors association with rOD within one-year. Relative risk of repeated opioid overdose was estimated using adjusted Cox proportional hazard ratios (aHRs).Results14.9 % of patients (95 % CI 13.9-16.1) had a rOD, with 29 % occurring within 30 days from iOD. The adjusted hazard of opioid overdose was increased for male patients (aHR = 1.19; 95 % CI 1.01, 1.41), those with pre-iOD diagnoses of anxiety (aHR = 1.41; 95 % CI1.13, 1.77), depression (aHR = 1.44; 95 % CI 1.17, 1.78), substance use disorders (aHR = 1.30; 95 % CI 1.09, 1.55), and alcohol use disorder (aHR = 1.52; 95 % CI 1.02, 2.25). The hazard was lower for individuals prescribed an opioid in the 90 days prior to iOD (aHR = 0.59; 95 % CI 0.37, 0.97) and those admitted to the hospital for iOD (aHR = 0.56; 95 % CI 0.37, 0.86).ConclusionWe found that, among ED patients who survive an initial OD, mental health and substance use diagnoses are associated with a higher hazard of repeated overdoses whereas opioids prescriptions and admission are associated with lower hazards.
| S-EPMC7127977 | biostudies-literature
Project description:ImportancePrevious unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose.ObjectiveTo test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose.Design, setting, and participantsA double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo).InterventionsClients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 μg per 1 mL and intranasal administration of placebo 1 mL.Main outcomes and measuresThe primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 μg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13.ResultsA total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group.Conclusions and relevanceThis trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority.Trial registrationanzctr.org.au Identifier: ACTRN12611000852954.
| S-EPMC6902775 | biostudies-literature
Project description:IntroductionThis study was designed to compare the effects of intranasal (IN) and intravenous (IV) administration of naloxone in patients who had overdosed on opioids.Material and methodsThis randomized clinical trial study was conducted in the Department of Poisoning Emergencies at Noor and Ali Asghar (PBUH) University Hospital. One hundred opioid overdose patients were assigned by random allocation software into two study groups (n = 50). Both groups received 0.4 mg naloxone: one group IN and the other IV. Outcomes included change in the level of consciousness (measured using a descriptive scale and the Glasgow Coma Scale (GCS)), time to response, vital signs (blood pressure, heart rate and respiratory rate), arterial blood O2 saturation before and after naloxone administration, side-effects (agitation) and length of hospital stay.ResultsPatients who had been administered IN naloxone demonstrated significantly higher levels of consciousness than those in the IV group using both descriptive and GCS scales (p < 0.001). There was a significant difference in the heart rate between IN and IV groups (p = 0.003). However, blood pressure, respiratory rate and arterial O2 saturation were not significantly different between the two groups after naloxone administration (p = 0.18, p = 0.17, p = 0.32). There was also no significant difference in the length of hospital stay between the two groups (p = 0.14).ConclusionsIntranasal naloxone is as effective as IV naloxone in reversing both respiratory depression and depressive effects on the central nervous system caused by opioid overdose.
| S-EPMC4042052 | biostudies-literature
Project description:IntroductionCurrent ethical practice allows for adult patients with decision-making capacity to refuse blood transfusion, even at the cost of high morbidity or mortality. However, for an adult patient who is of the Jehovah's Witness faith, an unwanted blood transfusion confers a psychospiritual cost to the patient and a financial cost to health care entities. The ethical boundaries are increasingly ambiguous with minors who are members of the Jehovah's Witness faith. This simulation experience intends to identify and address knowledge gaps in the care of minors in an emergent setting using a biomedical ethics framework.MethodsThis scenario provides an immersive simulation experience involving a 12-year-old Jehovah's Witness patient requiring emergent laparotomy for splenic hemorrhage. Patient interview (via simulation manikin with instructor voice) and care handoff take place in an operating room setting. The learner ascertains the patient's and family's refusal of blood products. Induction of general anesthesia results in profound patient hypotension secondary to acute blood-loss anemia. Pulseless electrical activity results if packed red blood cells are not administered. Ethical principles require the learner to impose an unwanted lifesaving therapy on a minor patient over the objections of family members. Secondly, the anesthesia provider must advocate for transfusion on these ethical grounds against a well-meaning but ultimately misguided surgeon who opposes transfusion. An included learner evaluation form based on ACGME core competencies facilitates postsimulation debriefing.ResultsParticipants were primarily anesthesia residents and fellows. Anecdotally, the residents said that it "felt good to be an attending" and that the simulation helped them appreciate how important conflict resolution skills are in the OR setting. Additionally, faculty appreciated the ability to assess the development of crucial assertiveness skills, with the option of remediating incorrect behavior during the debriefing.DiscussionThis simulation experience provides experience in the emergent medical management of a pediatric trauma patient while also incorporating specific ethical consent issues unique to pediatric and trauma patient populations. Furthermore, this experience develops professionalism skills and practice in assertive patient advocacy.
| S-EPMC6464417 | biostudies-literature
Project description:Approximately 1 in 10 newborns will require basic resuscitation interventions at birth. Some infants progress to require more advanced measures including the provision of positive pressure ventilation, chest compressions, intubation and administration of volume/cardiac medications. Although advanced resuscitation is infrequent, it is crucial that personnel adequately trained in these techniques are available to provide such resuscitative measures. In 2000, Louis Halmalek et al. called for a "New Paradigm in Pediatric Medical Education: Teaching Neonatal Resuscitation in a Simulated Delivery Room Environment." This was one of the first articles to highlight simulation as a method of teaching newborn resuscitation. The last decades have seen an exponential growth in the area of simulation in newborn care, in particular in newborn resuscitation and stabilization. Simulation is best defined as an instructional strategy "used to replace or amplify real experiences with guided experiences that evoke or replicate substantial aspects of the real world in a fully interactive manner." Simulation training has now become an important point of how we structure training and deliver improved healthcare to patients. Some of the key aspects of simulation training include feedback, deliberate practice, outcome measurement, retention of skills and curriculum integration. The term "Train to win" is often used in sporting parlance to define how great teams succeed. The major difference between sports teams is that generally their game day comes once a week, whereas in newborn resuscitation every day is potentially "game day." In this review we aim to summarize the current evidence on the use of simulation based education and training in neonatal resuscitation, with particular emphasis on the evidence supporting its effectiveness. We will also highlight recent advances in the development of simulation based medical education in the context of newborn resuscitation to ensure we "train to win."
| S-EPMC7052260 | biostudies-literature