Sandeep Ankolekar1, Ruth Parry2, Nikola Sprigg1, A Niroshan Siriwardena3, Philip M W Bath4. 1. Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK; Stroke Service, Nottingham University Hospitals National Health Service Trust, Nottingham, UK. 2. School of Health Sciences, University of Nottingham, Nottingham, UK. 3. School of Health and Social Care, University of Lincoln, UK. 4. Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK; Stroke Service, Nottingham University Hospitals National Health Service Trust, Nottingham, UK. Electronic address: philip.bath@nottingham.ac.uk.
Abstract
STUDY OBJECTIVE: Optimal practices for recruiting, consenting, and randomizing patients, and delivering treatment in out-of-hospital ultra-acute stroke trials, remain unclear. We aim to identify key barriers and facilitators relevant to the design and conduct of ambulance-based stroke trials and to formulate preliminary recommendations for the design of future trials. METHODS: Using semistructured interviews, we investigated the experiences and challenges faced by paramedics who took part in a randomized controlled trial in suspected ultra-acute stroke, the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT), in which recruitment, consent, randomization, assessment, and treatment were delivered by paramedics before hospitalization. RESULTS: We purposively selected a diversity sample of 14 of the 78 paramedics who participated in RIGHT. We identified 13 themes (7 facilitators and 6 barriers to out-of-hospital stroke research). A simple stroke diagnostic tool, use of proxy consent on behalf of patients, and straightforward trial processes were identified as the main facilitators. Recruitment became easier with each new randomization attempt. Key barriers reported were informed consent in the emergency setting, lack of institutional support for research, learning curve and rarity (each paramedic treats only a few eligible patients), and difficulty in attending training sessions. Interviewed paramedics were motivated to participate in research. CONCLUSION: Ultra-acute stroke research in the out-of-hospital environment is feasible, but important barriers need to be addressed. Proxy consent by paramedics addresses some of the difficulties with the consent process in the out-of-hospital setting.
STUDY OBJECTIVE: Optimal practices for recruiting, consenting, and randomizing patients, and delivering treatment in out-of-hospital ultra-acute stroke trials, remain unclear. We aim to identify key barriers and facilitators relevant to the design and conduct of ambulance-based stroke trials and to formulate preliminary recommendations for the design of future trials. METHODS: Using semistructured interviews, we investigated the experiences and challenges faced by paramedics who took part in a randomized controlled trial in suspected ultra-acute stroke, the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT), in which recruitment, consent, randomization, assessment, and treatment were delivered by paramedics before hospitalization. RESULTS: We purposively selected a diversity sample of 14 of the 78 paramedics who participated in RIGHT. We identified 13 themes (7 facilitators and 6 barriers to out-of-hospital stroke research). A simple stroke diagnostic tool, use of proxy consent on behalf of patients, and straightforward trial processes were identified as the main facilitators. Recruitment became easier with each new randomization attempt. Key barriers reported were informed consent in the emergency setting, lack of institutional support for research, learning curve and rarity (each paramedic treats only a few eligible patients), and difficulty in attending training sessions. Interviewed paramedics were motivated to participate in research. CONCLUSION: Ultra-acute stroke research in the out-of-hospital environment is feasible, but important barriers need to be addressed. Proxy consent by paramedics addresses some of the difficulties with the consent process in the out-of-hospital setting.
Authors: Kristina Shkirkova; Jeffrey L Saver; Sidney Starkman; Gregory Wong; Julius Weng; Scott Hamilton; David S Liebeskind; Marc Eckstein; Samuel Stratton; Frank Pratt; Robin Conwit; Nerses Sanossian Journal: JAMA Neurol Date: 2018-11-01 Impact factor: 18.302