Exploring the feasibility of conducting primary care trials in the Irish context: lessons from the IDEAs (Improving Diabetes Eye-screening Attendance) study

Problem

The research infrastructure in primary care is still developing and investment is relatively recent. Understanding practices’ ‘readiness’ to engage in trials and their experience is important to inform trial procedures and supports. However, there are few case studies of specifically conducting trials in the Irish context. We explored the acceptability and feasibility of study procedures used as part of a cluster randomised pilot trial of an intervention in primary care (July 2019 – July 2020) to improve uptake of Ireland’s national diabetic retinopathy programme, Diabetic RetinaScreen.

Approach

Eligible General Practices (GP) had ≥1practice nurse and computerised patient records. The intervention comprised practice reimbursement, an audit of patients with diabetes, electronic prompts targeting professionals, GP-endorsed patient reminders, and a patient information leaflet. As part of the process evaluation, we explored feasibility and acceptability of the study procedures, by conducting interviews with a purposive sample of staff from four intervention practices, consulting research logs, and, analysing audit data. Interviews were analysed using the Framework Method.

Findings

Nine staff (3 GPs, 4 nurses, 2 administrators) were interviewed. An interest in the topic area or research motivated practices to take part in the trial. Reimbursement meant they could ‘afford’ to participate. Staff valued the researcher briefing at the start of the trial, to avoid ‘going in slightly blind’, and felt everyone involved in the study needs to understand the nature of the investment required (i.e., skills, workload) before they decided to take part and to ensure these resources are in place. Not all staff were involved in the decision to take part in the study and did not receive the explanatory information. While staff varied in audit skills and confidence, and some found this aspect challenging, a ‘step-by-step’ audit manual and regular researcher contact, helped them stay on track and troubleshoot during data collection (e.g., searches within GP software). Delays with starting and finishing the audit were linked to the timing; annual leave during Summer when the trial began and the busy flu vaccination period in October/November.

Consequences

Staff felt the study procedures were acceptable and feasible, highlighting the importance of dedicated time to brief staff on the trial, manuals, and regular contact with a readily accessible research team. Audit challenges suggest the need for greater guidance and support. Issues with the reach and clarity of the communication about study requirements, suggest the need to be upfront about the investment and staff skills required, to facilitate practices to assess their capability and capacity (i.e., readiness) to take on the extra work involved.