Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.

BACKGROUND Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved. OBJECTIVES This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care. METHODS A feasibility study was conducted in three general practices in Poland. Participants were physicians and patients with gastro-oesophageal reflux disease. Semi-structured interviews were held to obtain feedback about the usefulness, ease of use and overall experience with the TRANSFoRm tools and to identify potential usability issues. Data were analysed thematically. RESULTS A total of 5 physicians and 10 patients participated in the study. Physicians were satisfied with the usefulness of the system, as it enabled easier and faster identification, recruitment and follow-up of patients compared with existing methods. Patients found the TRANSFoRm apps easy to use to report patient outcomes. However, they also felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies. Two main usability issues were identified: physicians could not access the result of the randomization at the end of each visit, and participants could not locate the follow-up reminder email. CONCLUSIONS This study provides new evidence on the acceptability and feasibility of TRANSFoRm to enable automated identification, recruitment and follow-up of study participants in primary care trials. It also helps to better understand and address users' requirements in eHealth-supported clinical research.

[1]  F. Cappuccio,et al.  The challenges of cross-national research in primary health care across Europe. , 2005, Family practice.

[2]  Peter J. Embi,et al.  Physicians' perceptions of an electronic health record-based clinical trial alert approach to subject recruitment: A survey , 2008, BMC Medical Informatics Decis. Mak..

[3]  Laura Johnson,et al.  How Many Interviews Are Enough? , 2006 .

[4]  Joy Adamson,et al.  The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. , 2014, Health technology assessment.

[5]  M. Charlson,et al.  Applying results of randomised trials to clinical practice: impact of losses before randomisation. , 1984, British medical journal.

[6]  J. Moffett,et al.  Recruiting patients to randomized trials in primary care: principles and case study. , 2000, Family practice.

[7]  Corinne Alberti,et al.  Comparison of two data collection processes in clinical studies: electronic and paper case report forms , 2014, BMC Medical Research Methodology.

[8]  L. Faulkner.  Beyond the five-user assumption: Benefits of increased sample sizes in usability testing , 2003, Behavior research methods, instruments, & computers : a journal of the Psychonomic Society, Inc.

[9]  Brigitte Walther,et al.  Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data , 2011, PloS one.

[10]  P. Bower,et al.  Improving recruitment to health research in primary care. , 2009, Family practice.

[11]  F. Verheggen,et al.  Patient satisfaction with clinical trial participation. , 1998, International journal for quality in health care : journal of the International Society for Quality in Health Care.

[12]  Bill Byrom,et al.  ePro: Electronic Solutions for Patient-Reported Data , 2010 .

[13]  B. Delaney,et al.  General practice Randomised controlled trials in primary care : case study , 2022 .

[14]  S. Treweek,et al.  Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial , 2013, Trials.

[15]  L. Spencer,et al.  Qualitative data analysis for applied policy research , 2002 .

[16]  Katie Brittain,et al.  The effectiveness of collaborative care for people with memory problems in primary care: results of the CAREDEM case management modelling and feasibility study. , 2014, Health technology assessment.

[17]  Shannon J. Lane,et al.  Bmc Medical Informatics and Decision Making a Review of Randomized Controlled Trials Comparing the Effectiveness of Hand Held Computers with Paper Methods for Data Collection , 2006 .

[18]  Claire Snowdon,et al.  Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT , 2007, Trials.

[19]  M. Croughan.  Factors influencing physician participation in practice-based research network studies: a call for further research. , 2001, The Journal of family practice.

[20]  P. Bower,et al.  The clinical effectiveness, cost-effectiveness and acceptability of community-based interventions aimed at improving or maintaining quality of life in children of parents with serious mental illness: a systematic review. , 2014, Health technology assessment.

[21]  Vasa Curcin,et al.  A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol , 2015, Implementation Science.

[22]  Brian Boswell,et al.  Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial. , 2010, Informatics in primary care.