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Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

ABSTRACT: 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).

SUBMITTER: Orkin A

PROVIDER: S-EPMC6858090 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

Orkin Aaron A Campbell Douglas D Handford Curtis C Hopkins Shaun S Klaiman Michelle M Leece Pamela P Parsons Janet A JA Shahin Rita R Strike Carol C Thorpe Kevin K Sellen Kate K Milos Geoffrey G Wright Amy A Charles Mercy M Sniderman Ruby R Morrison Laurie L

BMJ open 20191112 11

<h4>Introduction</h4>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 ...[more]

PMID: 31722937

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Project description:IntroductionCommunity programs to teach nonmedical laypeople how to recognize an opioid overdose and effectively resuscitate the victim using naloxone have proliferated recently as a significant component of harm-reduction efforts. Although many such programs target laypeople like first responders or friends and family members of people who use drugs, there are currently no programs that specifically target addiction counselors, despite their work with a client population at high risk of an opioid overdose.MethodsThe four-hour curriculum designed by the authors covered opioid agonist and antagonist pharmacology; opioid toxidrome signs; legal implications and indications for using the naloxone kits; and hands-on training. Participants were two cohorts of addiction counselors and addiction counseling trainees at our institution and an affiliated Opioid Treatment Program methadone clinic. Surveys testing participant knowledge and confidence were conducted at baseline, immediately post-training, six months post-training, and 12 months post-training.ResultsOverall, opioid and naloxone pharmacology knowledge, as well as the confidence to intervene in an overdose emergency, improved among participants in both cohorts. Knowledge scores at baseline (n = 36, median 5/10) improved significantly immediately post-training (n = 31, median 7/10, P < 0.0001, Wilcoxon signed-rank test) and were sustained six (n = 19) and 12 months (n = 11) later. Two participants reported using their naloxone kits to successfully reverse a client overdose in the 12 months after taking the course.DiscussionThese results from our knowledge translation pilot project suggest that our educational program to train addiction counselors in opioid pharmacology and toxicology, allowing them to recognize and respond to an opioid overdose, is feasible and could be effective. Specific barriers to implementing such educational programs include cost, stigma, and unclear best practice for designing and conducting these programs.ConclusionsFurther study of providing opioid pharmacology education and overdose and naloxone training to addiction counselors and counseling trainees appears to be warranted.

Project description:The opioid crisis is a growing public health emergency and increasing resources are being directed towards overdose education. Simulation has emerged as a novel strategy for training overdose response, yet little is known about training non-clinicians in bystander resuscitation. Understanding the perspectives of individuals who are likely to experience or witness opioid overdose is critical to ensure that emergency response is effective. The Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) study evaluates the effectiveness of a novel naloxone education and distribution tool among people who are non-clinicians and likely to witness opioid overdose. Participants' resuscitation skills are evaluated using a realistic overdose simulation as the primary outcome of the trial. The purpose of our study is to describe the experience of participants with the simulation process in the SOONER study. We employed a semi-structured debriefing interview and a follow up qualitative interview to understand the experience of participants with simulation. A qualitative content analysis was performed using data from 21 participants who participated in the SOONER study. Our qualitative analysis identified 5 themes and 17 subthemes which described the experience of participants within the simulation process. These themes included realism, valuing practical experience, improving self-efficacy, gaining new perspective and bidirectional learning. Our analysis found that simulation was a positive and empowering experience for participants in the SOONER trial, most of whom are marginalized in society. Our study supports the notion that expanding simulation-based education to non-clinicians may offer an acceptable and effective way of supplementing current opioid overdose education strategies. Increasing the accessibility of simulation-based education may represent a paradigm shift whereby simulation is transformed from a primarily academic practice into a patient-based community resource.

Project description:Overdose Education and Naloxone Distribution (OEND) is an effective public health intervention to reduce opioid overdose fatalities (McDonald and Strang, Addiction 111:1177-1187, 2016). However, we know little about OEND implementation outcomes (i.e., indicators of implementation success), specifically the fidelity of training delivery, and how these may relate to intervention outcomes (i.e., indicators of the success or effectiveness of an intervention), such as overdose knowledge and attitudes. This study evaluated 16 OEND trainings conducted at different Opioid Overdose Prevention Programs in New York City. Trainees (N = 75) completed the Opioid Overdose Knowledge and Attitude Scales before and after training (intervention outcomes). Implementation outcomes were fidelity (competence and adherence of the trainer, N = 10; modified Fidelity Checklist) and acceptability of OEND (Acceptability of Intervention Measure), assessed from multiple perspectives (trainees, trainers, and an independent observer). Trainees' overdose knowledge, t(71) = - 8.12, p < 0.001, 95% CI [- 6.54, - 3.96], and attitudes, t(65) = - 6.85, p < 0.001, 95% CI [- 0.59, - 0.33], improved significantly from pre- to post-training. Stepwise multiple regression models indicated that adherence of the trainer rated from the observer perspective added significantly to the prediction of changes in overdose knowledge, F(1, 67) = 9.81, p = 0.003, and explained 13% of the variance in outcome. However, fidelity measures from the perspective of trainees or trainers and acceptability of OEND were not associated with changes in trainees' overdose knowledge or attitudes. OEND implementation outcomes and their relationship with intervention outcomes differed depending on the role of the fidelity rater in relation to the intervention. Specifically, our findings indicate that fidelity should be measured from an independent perspective (i.e., an individual who is experienced with fidelity rating but not directly involved in the intervention).Supplementary informationThe online version contains supplementary material available at 10.1007/s43477-021-00021-4.

Project description:ImportanceAs opioid-related mortality continues to increase, naloxone remains a critical intervention in preventing overdose death. Opportunities to expand access through the health care setting should be optimized.ObjectiveTo determine the characteristics of naloxone prescribing for US patients at high risk of opioid overdose.Design, setting, and participantsThis retrospective cohort study used Truven Health MarketScan data from October 1, 2015, through December 31, 2016, of individuals with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes related to opioid use, misuse, dependence, and overdose. The cohort included 138 108 commercially insured individuals aged 15 years or older in the United States with claims related to opioid misuse or dependence, opioid-related overdose, or both.ExposuresOutpatient naloxone pharmacy claims.Main outcomes and measuresDemographic characteristics, clinical characteristics, health care service use, and proportion prescribed naloxone were included in multivariable logistic regression analyses to test the association of opioid risk group with naloxone claim.ResultsOf 138 108 high-risk individuals (mean [SD] age, 43.4 [0.4] years; 72 435 [52.4%] men), 2135 (1.5%) were prescribed naloxone. Having prior diagnoses of both opioid misuse or dependence and overdose was associated with a greater likelihood of receiving naloxone (odds ratio [OR], 2.32; 95% CI, 1.98-2.72; P < .001) compared with having a prior diagnosis of opioid misuse or dependence without overdose. Having a prior diagnosis of opioid overdose alone was associated with a decreased likelihood of receiving naloxone (OR, 0.73; 95% CI, 0.57-0.94; P = .01) compared with having a prior diagnosis of opioid misuse or dependence without overdose. Factors associated with lower naloxone prescription included being aged 30 to 44 years (OR, 0.72; 95% CI, 0.62-0.84; P < .001) and being from the Midwest (OR, 0.62; 95% CI, 0.54-0.71; P < .001) or West (OR, 0.85; 95% CI, 0.74-0.98; P = .03). Opioid use disorder treatment, such as use of medication-assisted therapy (OR, 1.68; 95% CI, 1.53-1.86; P < .001), visiting a detoxification facility (OR, 1.51; 95% CI, 1.31-1.76; P < .001), or receiving other substance use disorder treatment (OR, 1.16; 95% CI, 1.04-1.30; P = .01), were associated with increased likelihood of receiving naloxone, as were receiving outpatient care from a pain specialist (OR, 1.57; 95% CI, 1.40-1.76; P < .001), psychologist (OR, 1.49; 95% CI, 1.29-1.70; P < .001), or surgeon (OR, 1.19; 95% CI, 1.08-1.32; P < .001). Overall, 98.5% (n = 135 973) of high-risk patients did not received naloxone, despite many interactions with the health care system, including 88 618 hospitalizations, 229 680 emergency department visits, 298 058 internal medicine visits, and 568 448 family practice visits.Conclusions and relevancePatients at high risk of opioid overdose rarely received prescriptions for naloxone despite numerous interactions with the health care system. Prescribing in emergency, inpatient, and outpatient settings represents an opportunity to improve access.

Dataset Information

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

Publications

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

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