Dataset Information

Patient Simulation for Assessment of Layperson Management of Opioid Overdose With Intranasal Naloxone in a Recently Released Prisoner Cohort.

ABSTRACT: Investigators applied simulation to an experimental program that educated, trained, and assessed at-risk, volunteering prisoners on opioid overdose (OD) prevention, recognition, and layperson management with intranasal (IN) naloxone.Consenting inmates were assessed for OD-related experience and knowledge then exposed on-site to standardized didactics and educational DVD (without simulation). Subjects were provided with IN naloxone kits at time of release and scheduled for postrelease assessment. At follow-up, the subjects were evaluated for their performance of layperson opioid OD resuscitative skills during video-recorded simulations. Two investigators independently scored each subject's resuscitative actions with a 21-item checklist; post hoc video reviews were separately completed to adjudicate subjects' interactions for overall benefit or harm.One hundred three prisoners completed the baseline assessment and study intervention and then were prescribed IN naloxone kits. One-month follow-up and simulation data were available for 85 subjects (82.5% of trained recruits) who had been released and resided in the community. Subjects' simulation checklist median score was 12.0 (interquartile range, 11.0-15.0) of 21 total indicated actions. Forty-four participants (51.8%) correctly administered naloxone; 16 additional subjects (18.8%) suboptimally administered naloxone. Nonindicated actions, primarily chest compressions, were observed in 49.4% of simulations. Simulated resuscitative actions by 80 subjects (94.1%) were determined post hoc to be beneficial overall for patients overdosing on opioids.As part of an opioid OD prevention research program for at-risk inmates, investigators applied simulation to 1-month follow-up assessments of knowledge retention and skills acquisition in postrelease participants. Simulation supplemented traditional research tools for investigation of layperson OD management.

SUBMITTER: Kobayashi L

PROVIDER: S-EPMC5300264 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Patient Simulation for Assessment of Layperson Management of Opioid Overdose With Intranasal Naloxone in a Recently Released Prisoner Cohort.

Kobayashi Leo L Green Traci C TC Bowman Sarah E SE Ray Madeline C MC McKenzie Michelle S MS Rich Josiah D JD

Simulation in healthcare : journal of the Society for Simulation in Healthcare 20170201 1

<h4>Introduction</h4>Investigators applied simulation to an experimental program that educated, trained, and assessed at-risk, volunteering prisoners on opioid overdose (OD) prevention, recognition, and layperson management with intranasal (IN) naloxone.<h4>Methods</h4>Consenting inmates were assessed for OD-related experience and knowledge then exposed on-site to standardized didactics and educational DVD (without simulation). Subjects were provided with IN naloxone kits at time of release and ...[more]

PMID: 28146450

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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.

Project description:ObjectivesDistribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.DesignFrom the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019-2021) was compared with a historic control period (2013-2017).SettingSkåne county, Sweden.ParticipantsGeneral population.InterventionsLarge-scale take-home naloxone distribution to individuals at risk of overdose.Primary and secondary outcome measuresDecrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.ResultsAnnual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.ConclusionsThe present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.Trial registration numberNCT03570099.

Project description:BackgroundRapid naloxone administration is crucial in reversing an opioid overdose. We investigated whether equipping community members, including people who use opioids (PWUO), with a smartphone application enabling them to signal and respond to suspected overdose would support naloxone administration in advance of Emrgency Medical Services (EMS).MethodsThis observational cohort study of opioid overdose intervention used a dedicated smartphone app, UnityPhilly, activated by volunteers witnessing an overdose to signal other nearby volunteers in Philadelphia (March 2019 - February 2020). Alerted volunteers chose to respond, or declined to respond, or ignored/missed the alert. Witnessing volunteer was connected to 9-1-1 through a semi-automated telephone call. The primary outcome was layperson-initiated overdose reversal before EMS arrival, and a secondary outcome was hospital transfer. This study is registered with ClinicalTrials.gov, NCT03305497.Findings112 volunteers, including 57 PWUO and 55 community members, signaled 291 suspected opioid overdose alerts. 89 (30⸱6%) were false alarms. For 202 true alerts, the rate of layperson initiated naloxone use was 36⸱6% (74/202 cases). Most naloxone-use cases occurred in the street (58⸱11% (43/74)) and some in home settings (22⸱98% (17/74)). The first naloxone dose was provided by a nearby volunteer responding to the alert in 29⸱73% (22/74) of cases and by the signaling volunteer in 70⸱27% (52/74) of cases. Successful reversal was reported in 95⸱9% (71/74) of cases. Layperson intervention preceded EMS by 5 min or more in 59⸱5% of cases. Recovery without hospital transport was reported in 52⸱7% (39/74) of cases.InterpretationOur findings support the benefits of equipping community members, potentially witnessing suspected opioid overdose, with naloxone and an emergency response community smartphone app, alerting EMS and nearby laypersons to provide additional naloxone.FundingFunding provided by NIH through NIDA, grant number: 5R34DA044758.

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

Patient Simulation for Assessment of Layperson Management of Opioid Overdose With Intranasal Naloxone in a Recently Released Prisoner Cohort.

Publications

Patient Simulation for Assessment of Layperson Management of Opioid Overdose With Intranasal Naloxone in a Recently Released Prisoner Cohort.

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