A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary c
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A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol Nikolaos Mastellos1*, Anna Andreasson2, Kit Huckvale1, Mark Larsen1, Vasa Curcin3, Josip Car1, Lars Agreus2 and Brendan Delaney3
Abstract Background: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. Methods/design: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. Discussion: The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. Trial registration: EudraCT: 2014-001314-25
Introduction Background
Recruitment to primary care trials is a particularly challenging process with most studies struggling to reach their recruitment targets. In fact, a survey of authors of 39 published primary care trials found that only 29% of UK primary care studies achieved their recruitment targets * Correspondence: [email protected] 1 Department of Primary Care and Public Health, School of Public Health, Imperial College London, 3rd Floor Reynolds Building, St Dunstan’s Road, London W6 8RP, UK Full list of author information is available at the end of the article
within the agreed timeframe, with 70% requiring additional time to recruit the predefined number of participants [1]. This is very worrying considering that clinical trials succeed or fail based on whether they manage to recruit
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