scholarly journals A Randomised Controlled Feasibility Trial of Music-Assisted Language Telehealth Intervention for Minimally Verbal Autistic Children - The MAP Study

2021 ◽  
Author(s):  
Tim I Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Musical Skills ◽  
Children With Asd ◽  
Wide Range ◽  
Imaging Research ◽  
Randomised Controlled

Abstract Background: About 30% of children with ASD do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children [1]. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods: Our music-assisted programmes (MAP) will use music to attract the attention of people with ASD to speech, which may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24-60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g., songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics [2]. Participants will be allocated to groups randomly. The efficacy of MAP will be assessed through the learning of 36 target words. The 36 words will be chosen so that they are relevant to the everyday activities that the children take part in. Discussion: This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP.Trial registration: ISRCTN, ISRCTN12536062. Registered 26 June 2019, https://www.isrctn.com/ISRCTN12536062

scholarly journals A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children—the MAP study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Tim I. Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Autism Spectrum ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Children With Asd ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods In this protocol, we describe our music-assisted programmes (MAP) that will use music to attract the attention of people with ASD to speech. MAP may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24–60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g. songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics. Participants will be allocated to groups randomly. The feasibility of MAP will be assessed through estimations of recruitment and retention rates, the sensitivity and reliability of the outcome measures, the intensity and frequency of the trial, the usability of the MAP app (beta version), and the burden of the assessments for the children and parents. Discussion This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP. Trial registration ISRCTN, ISRCTN12536062. Registered on 26 June 2019.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045922
Author(s):  
Laura Haigh ◽  
Stuart McPherson ◽  
John C Mathers ◽  
Quentin M Anstee
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Phase 1 ◽  
Feasibility Trial ◽  
Alcoholic Fatty Liver ◽  
Intervention Protocol ◽  
Randomised Controlled ◽  
Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

scholarly journals Can we rely on non-randomised studies? Findings from a meta-epidemiological review

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J C Rejon-Parrilla ◽  
M Salcher-Konrad ◽  
M Nguyen ◽  
K Davis ◽  
P Jonsson ◽  
...  
Keyword(s):  
Health Economic ◽  
Analytical Methods ◽  
Large Scale ◽  
Treatment Effects ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Risk Of Bias ◽  
Economic Decision Making ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background Increasingly, health technology assessment (HTA) agencies must decide whether new medicines should be used routinely in the absence of randomised controlled trial (RCT) data, relying solely on non-randomised studies (NRS), which are at high risk of bias due to confounding. Against the background of increased availability and improved methods to analyse non-randomised data (e.g., propensity score methods and instrumental variables), it is important for decision-makers to have guidance on the analysis and interpretation of NRS to inform health economic evaluation. We therefore aimed to systematically and empirically assess the performance of NRS using different analytical methods as compared to RCTs and develop recommendations on the basis of our findings. Methods We conducted a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in matched RCTs and NRS of pharmacologic interventions from published meta-analyses indexed in MEDLINE and the Cochrane Database of Systematic Reviews. We also consulted with HTA bodies, regulators and academics from five European countries to learn from their experience with using non-randomised evidence. Results We compiled the largest dataset of clinical topics with matching RCTs and NRS using various analytical methods to date, covering &gt;100 unique clinical questions. Incorporating information on direction of effect and effect size from &gt;700 unique studies, the dataset can be used to evaluate discrepancies in treatment effects between study designs across a wide range of therapeutic areas. Conclusions An empirically based understanding of the risk of bias in NRS is required in order to promote the adequate use of non-randomised evidence as input for health economic decision-making.

scholarly journals Hughes Abdominal Repair Trial (HART)—abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017235 ◽  
Author(s):  
Rhiannon L Harries ◽  
Julie Cornish ◽  
David Bosanquet ◽  
Buddug Rees ◽  
James Horwood ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Data Monitoring Committee ◽  
Feasibility Trial ◽  
Abdominal Wall Closure ◽  
Incisional Hernias ◽  
Mass Closure ◽  
Monitoring Committee ◽  
Randomised Controlled

ObjectivesIncisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.Design and settingA feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.ParticipantsPatients undergoing midline incisional surgery for resection of colorectal cancer.InterventionsComparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.Primary and secondary outcomesA 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.ResultsA total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.ConclusionsThe feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.Trial registration numberISRCTN 25616490.

scholarly journals Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Sarah Scobie ◽  
Sue Jowett ◽  
Tosin Lambe ◽  
Smitaa Patel ◽  
Rebecca Woolley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Language Therapy ◽  
Voice Treatment ◽  
Cost Consequence ◽  
Randomised Controlled

Abstract Background The PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT® LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson’s disease (PwPD) with self-reported problems with voice or speech. This analysis compares costs and quality of life outcomes between the trial arms, and considers the validity of the alternative outcome measures for economic evaluations. Methods A comparison of costs and outcomes was undertaken alongside the PD COMM pilot trial involving three arms: LSVT® LOUD treatment (n = 30); standard NHS SLT (n = 30); and a control arm (n = 29) excluded from receiving therapy for at least 6 months after randomisation unless deemed medically necessary. For all trial arms, resource use and NHS, social care and patient costs and quality of life were collected prospectively at baseline, 3, 6, and 12 months. Total economic costs and outcomes (EQ-5D-3L, ICECAP-O) were considered over the 12-month follow-up period from an NHS payer perspective. Quality of life measures for economic evaluation of SLT for people with Parkinson’s disease were compared. Results Whilst there was no difference between arms in voice or quality of life outcomes at 12 months, there were indications of differences at 3 months in favour of SLT, which need to be confirmed in the main trial. The estimated mean cost of NHS care was £3288 per patient per year for the LSVT® LOUD arm, £2033 for NHS SLT, and £1788 for the control arm. EQ-5D-3L was more strongly correlated to voice impairment than ICECAP-O, and was sensitive to differences in voice impairment between arms. Conclusions The pilot did not identify an effect of SLT on disease-specific or economic outcomes for PwPD at 12 months; however, there appeared to be improvements at 3 months. In addition to the sample size not powered to detect difference in cost-consequence analysis, many patients in the control arm started SLT during the 12-month period used for economic analysis, in line with the study protocol. The LSVT® LOUD intervention was more intense and therefore more costly. Early indications suggest that the preferred economic outcome measure for the full trial is EQ-5D-3L; however, the ICECAP-O should still be included to capture a broader measure of wellbeing. Trial registration International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

PP25 The take home naloxone intervention multicentre emergency setting feasibility (TIME) trial: an early perspective from one UK ambulance service

2021 ◽  
Vol 38 (9) ◽  
pp. A11.1-A11
Author(s):  
Sasha Johnston ◽  
Helen Snooks ◽  
Jenna Jones ◽  
Fiona Bell ◽  
Jonathan Benger ◽  
...  
Keyword(s):  
Life Support ◽  
Controlled Trial ◽  
Advanced Life Support ◽  
Time Trial ◽  
Ambulance Service ◽  
Feasibility Trial ◽  
Royal Infirmary ◽  
Emergency Setting ◽  
Training Time ◽  
Randomised Controlled

BackgroundDrug poisoning deaths in England and Wales have increased by 52% since 2011 with over half involving opioids. Deaths are preventable if naloxone is administered in time. Take Home Naloxone (THN) kits have been distributed through drug services; however, uptake is low and effectiveness unproven. The TIME trial tests the feasibility of conducting a full randomised controlled trial of providing THN administration and basic life support training to high-risk opioid-users in emergency care settings.MethodsA multi-site feasibility trial commenced in June 2019 with two hospitals and their surrounding ambulance services (Bristol Royal Infirmary (BRI) with South Western Ambulance NHS Foundation Trust (SWASFT) and Hull Royal Infirmary with Yorkshire Ambulance Service) randomly allocated to intervention arms; and sites in Wrexham and Sheffield allocated as ‘usual care’ controls. SWASFT began recruiting in October 2019 with the aim of recruiting and training 50% (n=111) of paramedics working within the BRI’s catchment area, to supply THN to at least 100 eligible patients during a 12-month period.ResultsThe trial was suspended between 17.03.2020-06.08.2020 and extended to 01.03.2021 (COVID-19). Despite this, 121 SWASFT paramedics undertook TIME training. TIME trained paramedics attended 30% (n=57) of the n=190 opioid-related emergency calls requiring naloxone administration during the study period. A total of n=29 potentially eligible patients were identified before and n=28 after the COVID-19 suspension. Two patients were supplied with THN during each period. During the COVID-19 suspension, twenty-two potentially eligible patients were missed. The majority of eligible patients presented with a reduced consciousness level, preventing recruitment (73%; n=42/48). These patients were transported to hospital for further treatment (n=39) or died on scene following advanced life support (n=3).ConclusionsThe lowered consciousness levels of prehospital emergency ambulance patients who present with opioid poisoning, often prevent the delivery of training required to enable the supply of THN.

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