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Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.

ABSTRACT: 'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.Cluster randomised trial with staggered allocation of paramedics (clusters) to groups. We will invite paramedics in an urban area of south Wales, UK to take part. We will randomly allocate those that accept to training sessions during the first 4 months of the trial. Patients attended by paramedics who have been trained and issued THN kits will fall into the intervention group. Patients attended by paramedics following usual practice (until they receive their training and THN kits) will fall into the control group. We will gather data about processes and outcomes of care: numbers of patients eligible for intervention, offered and accepted THN, attended emergency department, suffered further overdose, died within 3 months and about follow-up rates: numbers of patients consented, completed (postal or telephone) questionnaire. We will gather qualitative data about acceptability to patients and paramedics through interviews and focus groups.Ethical approval for this study was granted on 7 December 2011, by South East Wales Research Ethics Committee, Panel C. Results of this study will be reported through peer-reviewed scientific journals, conference presentations and internal organisational report. We will also seek to report our findings through local and national substance misuse networks and publications.ISRCTN98216498.

SUBMITTER: Moore C

PROVIDER: S-EPMC3963087 | biostudies-other | 2014 Mar

REPOSITORIES: biostudies-other

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Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.

Moore Chris C Lloyd Gregory G Oretti Rossana R Russell Ian I Snooks Helen H

BMJ open 20140320 3

<h4>Introduction</h4>'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.<h4>Method ...[more]

PMID: 24650810

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Project description:ImportanceConcerns that take-home naloxone (THN) training may lead to riskier drug use (as a form of overdose risk compensation) remain a substantial barrier to training implementation. However, there was limited good-quality evidence in a systematic review of the association between THN access and subsequent risk compensation behaviors.ObjectiveTo assess whether THN training is associated with changes in overdose risk behaviors, indexed through injecting frequency, in a cohort of people who inject drugs.Design, setting, and participantsThis cohort study used prospectively collected self-reported behavioral data before and after THN training of participants in The Melbourne Injecting Drug User Cohort Study (SuperMIX). Annual interviews were conducted in and around Melbourne, Victoria, Australia, from 2008 to 2021. SuperMIX participants were adults who regularly injected heroin or methamphetamine in the 6 months preceding their baseline interview. The current study included only people who inject drugs who reported THN training and had participated in at least 1 interview before THN training.ExposureIn 2017, the SuperMIX baseline or follow-up survey began asking participants if and when they had received THN training. The first THN training date that was recorded was included as the exposure variable. Subsequent participant interviews were excluded from analysis.Main outcomes and measuresInjecting frequency was the primary outcome and was used as an indicator of overdose risk. Secondary outcomes were opioid injecting frequency, benzodiazepine use frequency, and the proportion of the time drugs were used alone. Fixed-effects generalized linear (Poisson) multilevel modeling was used to estimate the association between THN training and the primary and secondary outcomes. Time-varying covariates included housing status, income, time in study, recent opioid overdose, recent drug treatment, and needle and syringe coverage. Findings were expressed as incidence rate ratios (IRRs) with 95% CIs.ResultsThere were 1328 participants (mean [SD] age, 32.4 [9.0] years; 893 men [67.2%]) who completed a baseline interview in the SuperMIX cohort, and 965 participants completed either a baseline or follow-up interview in or after 2017. Of these 965 participants, 390 (40.4%) reported THN training. A total of 189 people who inject drugs had pretraining participant interviews with data on injecting frequency and were included in the final analysis (mean [SD] number of interviews over the study period, 6.2 [2.2]). In fixed-effects regression analyses adjusted for covariates, there was no change in the frequency of injecting (IRR, 0.91; 95% CI, 0.69-1.20; P = .51), opioid injecting (IRR, 0.95; 95% CI, 0.74-1.23; P = .71), benzodiazepine use (IRR, 0.96; 95% CI, 0.69-1.33; P = .80), or the proportion of reported time of using drugs alone (IRR, 1.04; 95% CI, 0.86-1.26; P = .67) before and after THN training.Conclusions and relevanceThis cohort study of people who inject drugs found no evidence of an increase in injecting frequency, along with other markers of overdose risk, after THN training and supply. The findings suggest that THN training should not be withheld because of concerns about risk compensation and that advocacy for availability and uptake of THN is required to address unprecedented opioid-associated mortality.

Project description:BACKGROUND:According to the principles of Reablement, home care services are meant to be goal-oriented, holistic and person-centred taking into account the capabilities and opportunities of older adults. However, home care services traditionally focus on doing things for older adults rather than with them. To implement Reablement in practice, the 'Stay Active at Home' programme was developed. It is assumed that the programme leads to a reduction in sedentary behaviour in older adults and consequently more cost-effective outcomes in terms of their health and wellbeing. However, this has yet to be proven. METHODS/ DESIGN:A two-group cluster randomised controlled trial with 12 months follow-up will be conducted. Ten nursing teams will be selected, pre-stratified on working area and randomised into an intervention group ('Stay Active at Home') or control group (no training). All nurses of the participating teams are eligible to participate in the study. Older adults and, if applicable, their domestic support workers (DSWs) will be allocated to the intervention or control group as well, based on the allocation of the nursing team. Older adults are eligible to participate, if they: 1) receive homecare services by the selected teams; and 2) are 65 years or older. Older adults will be excluded if they: 1) are terminally ill or bedbound; 2) have serious cognitive or psychological problems; or 3) are unable to communicate in Dutch. DSWs are eligible to participate if they provide services to clients who fulfil the eligibility criteria for older adults. The study consists of an effect evaluation (primary outcome: sedentary behaviour in older adults), an economic evaluation and a process evaluation. Data for the effect and economic evaluation will be collected at baseline and 6 and/or 12 months after baseline using performance-based and self-reported measures. In addition, data from client records will be extracted. A mixed-methods design will be applied for the process evaluation, collecting data of older adults and professionals throughout the study period. DISCUSSION:This study will result in evidence about the effectiveness, cost-effectiveness and feasibility of the 'Stay Active at Home' programme. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03293303 , registered on 20 September 2017.

Project description:Background: The increasing toxicity of opioids in the unregulated drug market has led to escalating numbers of overdoses in Canada and worldwide; takehome naloxone (THN) is an evidence-based intervention that distributes kits containing naloxone to people in the community who may witness an overdose. The purpose of this guidance is to provide policy recommendations for territorial, provincial and federal THN programs, using evidence from scientific and grey literature and community evidence that reflects 11 years of THN distribution in Canada. Methods: The Naloxone Guidance Development Group — a multidisciplinary team including people with lived and living experience and expertise of drug use — used the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument to inform development of this guidance. We considered published evidence identified through systematic reviews of all literature types, along with community evidence and expertise, to generate recommendations between December 2021 and September 2022. We solicited feedback on preliminary recommendations through an External Review Committee and a public input process. The project was funded by the Canadian Institutes of Health Research through the Canadian Research Initiative in Substance Misuse. We used the Guideline International Network principles for managing competing interests. Recommendations: Existing evidence from the literature on THN was of low quality. We incorporated evidence from scientific and grey literature, and community expertise to develop our recommendations. These were in 3 areas: routes of naloxone administration, THN kit contents and overdose response. Take-home naloxone programs should offer the choice of both intramuscular and intranasal formulations of naloxone in THN kits. Recommended kit contents include naloxone, a naloxone delivery device, personal protective equipment, instructions and a carrying case. Trained community overdose responders should prioritize rescue breathing in the case of respiratory depression, and conventional cardiopulmonary resuscitation in the case of cardiac arrest, among other interventions. Interpretation: This guidance development project provides direction for THN programs in Canada in the context of limited published evidence, with recommendations developed in collaboration with diverse stakeholders.

Project description:BackgroundTake home naloxone (THN) programs reduce mortality by training bystanders to respond to opioid overdoses. Clinical observation by the health care team at the Inner City Youth (ICY) program indicated that young adults appeared to enthusiastically participate in the THN program and developed improved relationships with staff after THN training. However, we found a dearth of literature exploring the experiences of young adults with THN programs. This study set out to address this gap and identify suggestions from the young adults for program improvement. The primary research question was "How do street-involved young people experience the THN Program in Vancouver, BC?"MethodsThe study was undertaken at the ICY Program. Two peer researchers with lived experience of THN were recruited from ICY and were involved in all phases of the study. The peer researchers and a graduate student facilitated two focus groups and five individual interviews with ICY program participants using a semi-structured interview guide. Audio recordings were transcribed verbatim. The cut-up-and-put-in-folders approach was used to identify emerging themes.ResultsThe themes that emerged were perceptions of risk, altruism, strengthening relationship with staff, access to training, empowerment, and confidence in ability to respond, and suggestions for youth-friendly training. These themes were then situated within the framework of the health belief model to provide additional context. Participants viewed themselves as vulnerable to overdose and spoke of the importance of expanding access to THN training. Following training, participants reported an increase in internal locus of control, an improved sense of safety among the community of people who use drugs, improved self-esteem, and strengthened relationships with ICY staff. Overall, participants found THN training engaging, which appeared to enhance participation in other ICY programming.ConclusionsYoung people perceived THN training as a positive experience that improved relationships with staff. Participant recommendations for quality improvement were implemented within the provincial program.

Project description:BackgroundOpioid overdoses are a growing concern, particularly among people who inject drugs. Sweden, with a comparatively high proportion of drug-related mortality, introduced its first Take-Home Naloxone (THN) program in 2018, at the Stockholm needle and syringe program (NSP). In this study we compare THN participant characteristics regarding refills and overdose reversals as well as investigate predictors associated with number of reversals. We also investigate interventions performed in overdose situations and endpoints for naloxone doses.MethodsThis was a prospective open inclusion cohort study conducted between January 24th 2018 and March 31st 2022 at the Stockholm NSP. Participants received THN, free of charge, after a training session and provided data regarding drug use and overdose experiences. During refill visits, participants reported if the naloxone was used for overdose reversal and, if so, responded to a ten-item questionnaire which included stating whether the naloxone recipient was the participant themselves or somebody else. Questionnaire data was combined with NSP database demographic data. Zero-inflated Poisson regression was applied to analyse predictors for number of reported overdose reversals.ResultsAmong study participants (n = 1,295), 66.5% stated opioids as their primary drug, and 61.4% and 81.0% had previous experience of a personal or witnessed overdose, respectively. Overall, 44.0% of participants reported a total of 1,625 overdose reversals and the victim was known to have survived in 95.6% of cases. Stimulant use (aIRR 1.26; 95% CI 1.01, 1.58), benzodiazepine use (aIRR 1.75; 95% CI 1.1, 2.78) and homelessness (aIRR 1.35; 95% CI 1.06, 1.73) were predictors associated with an increased number of reported overdose reversals. Mortality was higher among those who reported at least one overdose reversal (HR 3.4; 95% CI 2.2, 5.2).ConclusionsAn NSP's existent framework can be utilised to effectively implement a THN program, provide basic training and reach numerous high-risk individuals. During the four-year study, THN participants reversed a sizeable number of potentially fatal overdoses, of which many were reported by participants whose primary drug was not opioids. Naloxone refill rate was high, indicating that participants were motivated to maintain a supply of naloxone in case of future overdose events.

Dataset Information

Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.

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Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.

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