22. European Stroke Conference E-Poster Terminal 2 564 © 2013 S. Karger AG, Basel Scientific Programme 29 Large clinical trials (RCTs) Training caregivers after stroke: process evaluation of the implementation of the London Stroke Caregiver Training Course (LSCTC) in a pragmatic cluster randomised controlled tri-al. D.J. Clarke1, R. Hawkins2, E.S. Sadler3, G. Harding4, A. Forster5, C. McKevitt6, M. Godfrey7, J. Dickerson8, A.J Farrin9, L. Kalra10, D. Smithard11 Academic Unit of Elderly Care and Rehabilitation , University of Leeds, Leeds, UNITED KINGDOM1, Leeds Institute of Health Sciences, University of Leeds, Leeds, UNITED KING-DOM2, Department of Primary Care and Public Health Sciences, King’s College London, London, UNITED KINGDOM3, Peninsula College of Medicine and Dentistry, University of Exeter, Exeter, UNITED KINGDOM4, Academic Unit of Elderly Care and Rehabilitation , University of Leeds, Leeds, UNITED KINGDOM5, Department of Primary Care and Public Health Sciences, King’s College London, London, UNITED KINGDOM6, Leeds Institute of Health Sciences, University of Leeds, Leeds, UNITED KINGDOM7, Academic Unit of Elderly Care and Rehabilitation , Univer-sity of Leeds, Leeds, UNITED KINGDOM8, Clinical Trials Research Unit, University of Leeds, Leeds, UNITED KINGDOM9, Department of Stroke Medicine Guy’s, King’s & St Thomas’ School of Medicine, Kings College London, London, UNITED KINGDOM10, Department of Stroke Medicine Guy’s, King’s & St Thomas’ School of Medicine, Kings College London, London, UNITED KINGDOM11 Background: Most long-term care to stroke survivors is provided by family carers who receive little preparation for this often challenging role. The pragmatic multicentre cluster randomised controlled trial (Training Caregivers after Stroke (TRACS) sought to determine whether the London Stroke Caregiver Training Course (LSCTC), a structured competency based in-patient caregiver training programme, improved patients’ functional independence and reduced caregiver burden when deliv-ered as part of routine stroke unit care. Methods: To assist in interpretation of the TRACS trial results and to understand the contexts in which the LSCTC was implemented, a process evaluation was undertaken in parallel to the trial. Results: Over 1200 hours of observation were undertaken in six intervention and four control stroke units. Interviews were conducted with staff (n=53), patients and caregivers (n=37 pairs); documenta-ry analysis was undertaken. In most intervention units senior therapists engaged with and delivered components of the LSCTC. However, cascade training did not reach all staff or lead to multidisciplinary team (MDT) wide un-derstanding and engagement with the LSCTC. Caregivers had limited opportunities to make sense of and participate in developing knowledge and skills as part of the LSCTC. Conclusions: Delivery of structured caregiver training programmes is unlikely to be practical in stroke units with short inpatient stays. Early supported discharge schemes potentially offer a more sustained opportunity to introduce caregiver training consistent with the LSCTC. In the TRACS trial contextual factors including pressures for service improvement and staff perceptions of the necessity for and the work required in caregiver training significantly influenced implementation of the care-giver training intervention. Implementation of complex interventions such as the LSCTC requires prior and parallel exploration of factors which may facilitate or hinder their implementation. 28 Large clinical trials (RCTs) Development and testing of bespoke image data management system for large multicentre randomised clinical trials J.A. Adil-Smith1, D. Buchanan2, M. MacLeod3, B. Colam4, R. von Kummer5, J.M. Wardlaw6 EuroHYP-1 Consortium University of Edinburgh, Edinburgh, UNITED KINGDOM1, University of Edinburgh, Edin-burgh, UNITED KINGDOM2, University of Edinburgh, Edinburgh, UNITED KINGDOM3, Univer-sity of Edinburgh, Edinburgh, UNITED KINGDOM4, Technischen Universität Dresden, Dresden, GERMANY5, University of Edinburgh, Edinburgh, UNITED KINGDOM6 Introduction: The IST3 Image Management System was developed during a period of major chang-es in image data formats (from film to digital) and quantity (from axial scan of 20 images to volume scan of 300+ images). It also responded to challenges unique to large multi-centre international tri-als, e.g. differences in data quality; approaches to anonymisation and data security; handling many patients’ scan files (6576 scans by end of trial). We tested this system prior to using it to manage the imaging component of a new trial, EuroHYP-1, to identify any points for refinement and potential improvements in efficiency. Methods: We selected 50 anonymised patient files from the IST3 image archive and put them into PACS. A new entry was made for each “patient” in the scan Housekeeping database, including de-tails of each imaging study in the patient file. Each scan sequence was checked for validity/quality against criteria based on the EuroHYP-1 Image Acquisition Guidelines. The results of each check were entered into the Housekeeping database. Notes were kept of: details which could not be record-ed in the database; suggestions for changes to database or system. Results: We identified several changes required to the housekeeping system, including: sub-cate-gorisation of “on hold” status; grading of artefacts according to severity; ability to breakdown image attributes and select studies for future end uses, e.g. by slice thickness, anatomy coverage, suitability for volume analysis. Conclusion: Testing the Image Management System identified some scope for improvement. The Housekeeping database has been modified to collect additional key data (e.g. detailed image char-acteristics), and to optimise ease of use and interrogation. However the main functions were robust and efficient for the current era of medical imaging in clinical trials.
Karger_ESC London_2013
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