Browsing Publications - South Western Ambulance Service by Subject "Randomized Controlled Trials as Topic"
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An exploration of the experiences of paramedics taking part in a large randomised trial of airway management, and the impact on their views and practiceBackground The participation of over 1500 study paramedics in AIRWAYS-2 provides a unique opportunity for an in depth exploration of how the views and practice of study paramedics, in advanced airway management, may have developed as a result of their participation in AIRWAYS-2, and how their experiences can inform future trials in out-of-hospital cardiac arrest (OHCA). Future prehospital guidelines and practice will not only be shaped by the results of large trials such as AIRWAYS-2, but also by the views and attitudes of UK paramedics towards OHCA, airway management and research. This study allows an opportunity to add depth and understanding to the results of AIRWAYS-2. Study aims To explore paramedics’ experiences of participating in a large cluster randomized trial of airway management during OHCA, specifically: The challenges of enrolling patients who are critically unwell and unable to consent; Barriers and facilitators to successful research in OHCA patients; The impact on paramedics’ clinical practice and airway management during and after the trial; The role of advanced airway management during OHCA. Methods Content analysis of an online survey of 1500 study paramedics to assess their experiences of participating in the trial and to establish any changes in their views and practice. Thematic analysis of telephone interviews with study paramedic to explore the findings of the online questionnaire. Exploring any changes in views and practice around advanced airway management as a result of participating in the trial; assessing experiences of trial training and enrolling critically unwell patients without consent, and exploring the barriers and facilitators for trial participation and the views of paramedics on the future role of advanced airway management during OHCA. Results and conclusions The study is in the analysis phase and is due to complete and report by the 31st January 2019. https://emj.bmj.com/content/36/10/e12.1. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ DOI http://dx.doi.org/10.1136/emermed-2019-999abs.27
Research paramedics’ observations regarding the challenges and strategies employed in the implementation of a large-scale out-of-hospital randomised trialIntroduction: AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome. Methods: The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion. Results: The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated. Conclusion: Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties. Abstract published with permission.
Time: take-home naloxone in multicentre emergency settings: protocol for a feasibility studyBackground Opioids such as heroin kill more people worldwide than any other drug. Death rates associated with opioid poisoning in the UK are at record levels. Naloxone is an opioid agonist which can be distributed in take home ‘kits’. This intervention is known as Take Home Naloxone (THN). Methods We propose to carry out a randomised controlled feasibility trial (RCT) of THN distributed in emergency settings clustered by Emergency Department (ED) catchment area, and local ambulance service; with anonymised linked data outcomes. This will include distribution of THN by paramedics and ED staff to patients at risk of opioid overdose. Existing linked data will be used to develop a discriminant function to retrospectively identify people at high risk of overdose death based on observable predictors of overdose to include in outcome follow up. Results We will gather outcomes up to one year including; deaths (and drug related); emergency admissions; intensive care admissions; ED attendances (and overdose related); 999 attendances (and for overdose); THN kits issued; and NHS resource usage. We will agree progression criteria following consultation with research team members related to sign up of sites; successful identification and provision of THN to eligible participants; successful follow up of eligible participants and opioid decedents; adverse event rate; successful data matching and data linkage; and retrieval of outcomes within three months of projected timeline. Conclusions THN programmes are currently run by some drug services in the UK. However, saturation is low. There has been a lack of experimental research in to THN, and so questions remain: Does THN reduce deaths? Are there unforeseen harms associated with THN? Is THN cost effective? This feasibility study will establish whether a fully powered cluster RCT can be used to answer these questions. https://emj.bmj.com/content/36/1/e10.1. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ DOI http://dx.doi.org/10.1136/emermed-2019-999.24