Background Outcomes for stroke patients can be improved by rapid identification and assessment, but delays commonly occur due to the availability of clinical information and brain imaging. We sought to develop a novel paramedic-led intervention to reduce scene to needle time for stroke patients suitable for thrombolysis.

Methods Over 12 months we undertook group interviews and consultation in North East England, North West England and Wales involving patient representatives (n=20), paramedics, emergency department and stroke service hospital staff (n=100). The primary aim was to understand the impact of organisational boundaries, service pressures and traditional professional roles upon a new paramedic approach to stroke assessment. Secondly, to develop a clinical trial protocol for later evaluation of the proposed new paramedic approach. All interviews were digitally recorded, transcribed and analysed using open then focussed coding.

Results Participant feedback supported an intervention which transgressed organisational and professional boundaries.

Modifications were made following participant views about logistical, ethical and governance issues:

▸ The protocol was changed to reflect operational barriers restricting paramedics taking patients directly to the CT scan room.

▸ Participants advocated obtaining research consent after admission in order to address concerns over treatment delays, and supported a trial protocol which allowed data collection from patients that died before consent was feasible.

▸ Paramedics would provide additional information at patient handover directly to the stroke team or A&E staff rather than attempt to convey more during pre-notification.

Conclusions Following the interviews significant alterations were made to the intervention and protocol in order to improve trial feasibility, acceptability and data quality. This emphasizes the importance of engaging with ambulance services, other clinical teams and patients during the development of pre-hospital research protocols.