Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT

Snooks, Helen; Benger, Jonathan; Bell, Fiona; Black, Sarah; Dixon, Simon; Emery, Helena; Evans, Bridie; Fuller, Gordon; Hoskins, Rebecca; Hughes, Jane; Jones, Jenna; Jones, Matthew; Johnston, Sasha; Long, Jaqui; Moore, Chris; Parab, Rakshita; Pilbery, Richard; Sampson, Fiona C; Watkins, Alan

doi:10.3310/ynrc8249

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Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT

Helen Snooks

, Jonathan Benger

, Fiona Bell

, Sarah Black

, Simon Dixon

, Helena Emery

, Bridie Evans

, Gordon Fuller

, Rebecca Hoskins

, Jane Hughes

, Jenna Jones, Matthew Jones, Sasha Johnston

, Jaqui Long

, Chris Moore

, Rakshita Parab, Richard Pilbery

, Fiona C Sampson

, Alan Watkins

Health Technology Assessment, Volume: 28, Issue: 74, Pages: 1 - 69

Swansea University Authors: Helen Snooks , Helena Emery , Bridie Evans , Jenna Jones, Matthew Jones, Rakshita Parab, Alan Watkins

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DOI (Published version): 10.3310/ynrc8249

Abstract

Background: Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home ‘kits’ for peer administration (take-home naloxone). Aim: To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in em...

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Published in:	Health Technology Assessment
ISSN:	1366-5278 2046-4924
Published:	NIHR Journals Library 2024
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa68505

first_indexed	2024-12-09T19:47:29Z
last_indexed	2024-12-09T19:47:29Z
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Naloxone is an opioid antagonist which can be distributed in take-home ‘kits’ for peer administration (take-home naloxone). Aim: To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. Design: We used Welsh routine data (2015–21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. Setting: This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. Participants: At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Interventions: Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. Results: Discriminant function: With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Randomised controlled trial: Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: ‘forgot’ (n = 136); ‘too busy’ (n = 15); suspected intentional overdose (n = 3). Qualitative interviews: Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. Health economics: We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met – fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. Future work: The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. Limitations: The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. Conclusions: This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. Trial registration: This trial is registered as ISRCTN13232859. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.</abstract><type>Journal Article</type><journal>Health Technology Assessment</journal><volume>28</volume><journalNumber>74</journalNumber><paginationStart>1</paginationStart><paginationEnd>69</paginationEnd><publisher>NIHR Journals Library</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1366-5278</issnPrint><issnElectronic>2046-4924</issnElectronic><keywords/><publishedDay>31</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2024</publishedYear><publishedDate>2024-10-31</publishedDate><doi>10.3310/ynrc8249</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Not Required</apcterm><funders>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.</funders><projectreference/><lastEdited>2024-12-09T14:58:49.4712271</lastEdited><Created>2024-12-09T14:29:38.4908796</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Health Data Science</level></path><authors><author><firstname>Helen</firstname><surname>Snooks</surname><orcid>0000-0003-0173-8843</orcid><order>1</order></author><author><firstname>Jonathan</firstname><surname>Benger</surname><orcid>0000-0001-6131-0916</orcid><order>2</order></author><author><firstname>Fiona</firstname><surname>Bell</surname><orcid>0000-0003-4503-1903</orcid><order>3</order></author><author><firstname>Sarah</firstname><surname>Black</surname><orcid>0000-0001-6678-7502</orcid><order>4</order></author><author><firstname>Simon</firstname><surname>Dixon</surname><orcid>0000-0001-7394-7009</orcid><order>5</order></author><author><firstname>Helena</firstname><surname>Emery</surname><orcid>0000-0003-1890-4254</orcid><order>6</order></author><author><firstname>Bridie</firstname><surname>Evans</surname><orcid>0000-0003-0293-0888</orcid><order>7</order></author><author><firstname>Gordon</firstname><surname>Fuller</surname><orcid>0000-0001-8532-3500</orcid><order>8</order></author><author><firstname>Rebecca</firstname><surname>Hoskins</surname><orcid>0000-0001-7883-437X</orcid><order>9</order></author><author><firstname>Jane</firstname><surname>Hughes</surname><orcid>0000-0003-1389-3402</orcid><order>10</order></author><author><firstname>Jenna</firstname><surname>Jones</surname><orcid/><order>11</order></author><author><firstname>Matthew</firstname><surname>Jones</surname><order>12</order></author><author><firstname>Sasha</firstname><surname>Johnston</surname><orcid>0000-0002-9904-8834</orcid><order>13</order></author><author><firstname>Jaqui</firstname><surname>Long</surname><orcid>0000-0002-6889-6195</orcid><order>14</order></author><author><firstname>Chris</firstname><surname>Moore</surname><orcid>0000-0002-2192-3002</orcid><order>15</order></author><author><firstname>Rakshita</firstname><surname>Parab</surname><order>16</order></author><author><firstname>Richard</firstname><surname>Pilbery</surname><orcid>0000-0002-5797-9788</orcid><order>17</order></author><author><firstname>Fiona C</firstname><surname>Sampson</surname><orcid>0000-0003-2321-0302</orcid><order>18</order></author><author><firstname>Alan</firstname><surname>Watkins</surname><orcid>0000-0003-3804-1943</orcid><order>19</order></author></authors><documents/><OutputDurs/></rfc1807>
spelling	2024-12-09T14:58:49.4712271 v2 68505 2024-12-09 Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT ab23c5e0111b88427a155a1f495861d9 0000-0003-0173-8843 Helen Snooks Helen Snooks true false ddcdeaa3de5b3256ab5832a9a7377f1b 0000-0003-1890-4254 Helena Emery Helena Emery true false 6098eddc58e31ac2f3e070cb839faa6a 0000-0003-0293-0888 Bridie Evans Bridie Evans true false e662b6c5aba239a9cd0f115d16df0a82 Jenna Jones Jenna Jones true false e3595273bb063f8694ce43326f4bd298 Matthew Jones Matthew Jones true false 804e46a98acda1801a5b0eb26c5bcafe Rakshita Parab Rakshita Parab true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 2024-12-09 MEDS Background: Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home ‘kits’ for peer administration (take-home naloxone). Aim: To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. Design: We used Welsh routine data (2015–21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. Setting: This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. Participants: At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Interventions: Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. Results: Discriminant function: With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Randomised controlled trial: Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: ‘forgot’ (n = 136); ‘too busy’ (n = 15); suspected intentional overdose (n = 3). Qualitative interviews: Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. Health economics: We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met – fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. Future work: The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. Limitations: The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. Conclusions: This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. Trial registration: This trial is registered as ISRCTN13232859. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information. Journal Article Health Technology Assessment 28 74 1 69 NIHR Journals Library 1366-5278 2046-4924 31 10 2024 2024-10-31 10.3310/ynrc8249 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Not Required This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information. 2024-12-09T14:58:49.4712271 2024-12-09T14:29:38.4908796 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Helen Snooks 0000-0003-0173-8843 1 Jonathan Benger 0000-0001-6131-0916 2 Fiona Bell 0000-0003-4503-1903 3 Sarah Black 0000-0001-6678-7502 4 Simon Dixon 0000-0001-7394-7009 5 Helena Emery 0000-0003-1890-4254 6 Bridie Evans 0000-0003-0293-0888 7 Gordon Fuller 0000-0001-8532-3500 8 Rebecca Hoskins 0000-0001-7883-437X 9 Jane Hughes 0000-0003-1389-3402 10 Jenna Jones 11 Matthew Jones 12 Sasha Johnston 0000-0002-9904-8834 13 Jaqui Long 0000-0002-6889-6195 14 Chris Moore 0000-0002-2192-3002 15 Rakshita Parab 16 Richard Pilbery 0000-0002-5797-9788 17 Fiona C Sampson 0000-0003-2321-0302 18 Alan Watkins 0000-0003-3804-1943 19
title	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
spellingShingle	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT Helen Snooks Helena Emery Bridie Evans Jenna Jones Matthew Jones Rakshita Parab Alan Watkins
title_short	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
title_full	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
title_fullStr	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
title_full_unstemmed	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
title_sort	Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT
author_id_str_mv	ab23c5e0111b88427a155a1f495861d9 ddcdeaa3de5b3256ab5832a9a7377f1b 6098eddc58e31ac2f3e070cb839faa6a e662b6c5aba239a9cd0f115d16df0a82 e3595273bb063f8694ce43326f4bd298 804e46a98acda1801a5b0eb26c5bcafe 81fc05c9333d9df41b041157437bcc2f
author_id_fullname_str_mv	ab23c5e0111b88427a155a1f495861d9_*_Helen Snooks ddcdeaa3de5b3256ab5832a9a7377f1b__Helena Emery 6098eddc58e31ac2f3e070cb839faa6a__Bridie Evans e662b6c5aba239a9cd0f115d16df0a82__Jenna Jones e3595273bb063f8694ce43326f4bd298__Matthew Jones 804e46a98acda1801a5b0eb26c5bcafe__Rakshita Parab 81fc05c9333d9df41b041157437bcc2f_**_Alan Watkins
author	Helen Snooks Helena Emery Bridie Evans Jenna Jones Matthew Jones Rakshita Parab Alan Watkins
author2	Helen Snooks Jonathan Benger Fiona Bell Sarah Black Simon Dixon Helena Emery Bridie Evans Gordon Fuller Rebecca Hoskins Jane Hughes Jenna Jones Matthew Jones Sasha Johnston Jaqui Long Chris Moore Rakshita Parab Richard Pilbery Fiona C Sampson Alan Watkins
format	Journal article
container_title	Health Technology Assessment
container_volume	28
container_issue	74
container_start_page	1
publishDate	2024
institution	Swansea University
issn	1366-5278 2046-4924
doi_str_mv	10.3310/ynrc8249
publisher	NIHR Journals Library
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id	facultyofmedicinehealthandlifesciences
hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
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description	Background: Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home ‘kits’ for peer administration (take-home naloxone). Aim: To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. Design: We used Welsh routine data (2015–21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. Setting: This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. Participants: At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Interventions: Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. Results: Discriminant function: With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Randomised controlled trial: Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: ‘forgot’ (n = 136); ‘too busy’ (n = 15); suspected intentional overdose (n = 3). Qualitative interviews: Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. Health economics: We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met – fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. Future work: The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. Limitations: The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. Conclusions: This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. Trial registration: This trial is registered as ISRCTN13232859. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.
published_date	2024-10-31T14:39:04Z
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Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT

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