ACST-2 QRI
Research type
Research Study
Full title
Qualitative Recruitment Investigation of Asymptomatic Carotid Surgery Trial 2
IRAS ID
141746
Contact name
Alison Halliday
Contact email
Research summary
Background: The Asymptomatic Carotid Surgery Trial 2 (ASCT-2; MREC no. 05Q0201/66) began recruitment in 2008, with the definitive aim of recruiting serveral thousand patients. As of 1st November 2013, 1,287 patients had been enrolled into the trial. Whilst ACST-2 is now the largest investigator led trial in the world comparing stenting and surgery in patients with tight asymptomatic carotid stenosis, the TMG feel that patient enrolment could be maximised by reviewing the strategies implemented during patient recruitment process. Previous studies have shown that qualitative research can be integrated into RCTs when they are underway to maximise patient recruitment into the trial.
Aims and objectives: The aim of the current study is to understand the recruitment process of ASCT-2 and how it is operating in clinical centres, so that sources of recruitment difficulties can be identified and suggestions made to change aspects of design, conduct, and organisation.
Methods: This qualitative investigation will first aim to understand the recruitment process. This will involve mapping of patient eligibility and recruitment pathways, and analysing screening logs. Patient information leaflets and consent forms will be analysed to identify aspects that are unclear or potentially open to misinterpretation. In addition, semi-structured interviews with the trial management group (TMG), clinicians or researchers involved in trial recruitment (recruiters) and patients who are eligible for the trial. Staff-patient recruitment discussions about the trial will be also audio-recorded, where patients are first approached about the ACST-2 trial and invited to join. All 8 of the TMG, up to 20 recruiting staff and up to 20 patients may be recruited. The findings from this will then be presented with feedback, support and training sessions to the TMG and recruiting centres.
Funding source: Research Capability FundingREC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0409
Date of REC Opinion
29 Nov 2013
REC opinion
Favourable Opinion