Helen A Snooks, Jenna K Jones, Fiona B Bell, Jonathon R Benger, Sarah L Black, Simon Dixon, Adrian Edwards, Helena Emery, Bridie A Evans, Gordon W Fuller, Steve Goodacre, Rebecca Hoskins, Jane Hughes, Ann John, Sasha Johnston, Matthew B Jones, Chris R Moore, Rakshita Parab, Richard Pilbery, Fiona C Sampson, Alan Watkins
{"title":"紧急情况下带回家使用的纳洛酮：在分组随机试验中实施干预的可行性。","authors":"Helen A Snooks, Jenna K Jones, Fiona B Bell, Jonathon R Benger, Sarah L Black, Simon Dixon, Adrian Edwards, Helena Emery, Bridie A Evans, Gordon W Fuller, Steve Goodacre, Rebecca Hoskins, Jane Hughes, Ann John, Sasha Johnston, Matthew B Jones, Chris R Moore, Rakshita Parab, Richard Pilbery, Fiona C Sampson, Alan Watkins","doi":"10.1186/s12873-024-01061-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT).</p><p><strong>Methods: </strong>We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019-2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events.</p><p><strong>Results: </strong>At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported.</p><p><strong>Conclusion: </strong>Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned.</p><p><strong>Trial registration: </strong>ISRCTN13232859 (Registered 16/02/2018).</p>","PeriodicalId":9002,"journal":{"name":"BMC Emergency Medicine","volume":"24 1","pages":"155"},"PeriodicalIF":2.3000,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11360782/pdf/","citationCount":"0","resultStr":"{\"title\":\"Take-home naloxone administered in emergency settings: feasibility of intervention implementation in a cluster randomized trial.\",\"authors\":\"Helen A Snooks, Jenna K Jones, Fiona B Bell, Jonathon R Benger, Sarah L Black, Simon Dixon, Adrian Edwards, Helena Emery, Bridie A Evans, Gordon W Fuller, Steve Goodacre, Rebecca Hoskins, Jane Hughes, Ann John, Sasha Johnston, Matthew B Jones, Chris R Moore, Rakshita Parab, Richard Pilbery, Fiona C Sampson, Alan Watkins\",\"doi\":\"10.1186/s12873-024-01061-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT).</p><p><strong>Methods: </strong>We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019-2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events.</p><p><strong>Results: </strong>At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported.</p><p><strong>Conclusion: </strong>Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned.</p><p><strong>Trial registration: </strong>ISRCTN13232859 (Registered 16/02/2018).</p>\",\"PeriodicalId\":9002,\"journal\":{\"name\":\"BMC Emergency Medicine\",\"volume\":\"24 1\",\"pages\":\"155\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-08-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11360782/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Emergency Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12873-024-01061-3\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"EMERGENCY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Emergency Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12873-024-01061-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"EMERGENCY MEDICINE","Score":null,"Total":0}
Take-home naloxone administered in emergency settings: feasibility of intervention implementation in a cluster randomized trial.
Background: Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT).
Methods: We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019-2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events.
Results: At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported.
Conclusion: Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned.
期刊介绍：
BMC Emergency Medicine is an open access, peer-reviewed journal that considers articles on all urgent and emergency aspects of medicine, in both practice and basic research. In addition, the journal covers aspects of disaster medicine and medicine in special locations, such as conflict areas and military medicine, together with articles concerning healthcare services in the emergency departments.
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