Aim: To describe the performance of, barriers to, and implications of clinicians recruiting trial participants during consultations within two primary care feasibility cluster randomised controlled trials, CHICO and IMPACT-PC.
Methods: For the CHICO trial GP practices were randomised to a within consultation web-based intervention to reduce antibiotic prescribing for children with acute cough and respiratory tract infection, or usual care. For the IMPACT-PC trial GP practices were randomised to a nurse-led telephone based management service for patients testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG), or usual care. Performance data analyses were conducted and 44 clinicians and 26 trial participants (patients/parents) were interviewed post recruitment and analysed thematically to explore their experiences.
Results: For CHICO, 32 practices were randomised and 501 children were recruited one month ahead of schedule. More children were recruited to the intervention (292, 58%) than the control (209, 42%) arm. There was a difference in clinician type (higher proportion of nurses) and more unwell children in the intervention arm. Although just over a quarter of clinicians were nurses, they recruited more frequently, recruiting 220 (44%) of the children. Interviews revealed that many clinicians prioritised dealing with the cough first and only afterwards attempted to recruit children. This meant that clinicians, particularly in the control arm, reported they preferentially recruited less unwell children, because these were quicker and it was easier to ‘fit in’ the research on top of the normal consultation.
For IMPACT-PC, 11 practices were randomised, 1154 patients were recruited (60% of eligible patients) and 30 (2.6%) patients tested positive for CT, 9 (0.8%) tested positive for NG and 3 (0.3%) tested positive for both. CT positivity was higher (4.3%) amongst individuals’ eligible but not recruited to the study in intervention practices. Interviews revealed the main reason for failure to recruit eligible patients was insufficient time to undertake consent procedures. Despite patient consent being recorded, patients were sometimes unclear that they were participating in a research study. However, patients found both the intervention and the use of their medical records in evaluation acceptable, as long as their anonymity was maintained.
Conclusions: Recruitment to both trials was successful in terms of numbers recruited and timescales and the interventions were acceptable and feasible to clinicians and patients/parents. However, the requirement for individual patient/parent consent during the consultation was a barrier to recruitment and may have introduced bias. Given the nature of the interventions and the views expressed it is viable and valid that future trials of both interventions should not require individual consent providing the choice to opt out is provided and follow up procedures maintain patient anonymity. Trials evaluating the effectiveness of interventions for acute conditions in primary care should avoid recruitment processes that add burden to routine practice. The study highlights the value of conducting mixed method evaluations of recruitment performance and barriers during feasibility trials to inform future trial design.
|Title of host publication||Trials|
|Number of pages||1|
|Publication status||Published - 7 May 2017|
|Event||4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials - Arena and Convention Centre (ACC) Liverpool, Liverpool , United Kingdom|
Duration: 7 May 2017 → 10 May 2017
|Name||Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials|
|Conference||4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials|
|Period||7/05/17 → 10/05/17|
- BTC (Bristol Trials Centre)
- RCT randomised controlled trial
- Mixed methods evaluation
- Primary Care