Abstract
Background: Many clinical trials within ambulance services, require trained frontline paramedics to directly recruit or enrol eligible patients. Research paramedics may then review study documents and often contact recruiting paramedics to provide feedback or obtain missing data. Using the example of the Paramedic Analgesia Comparing Ketamine and MorphiNe in trauma (PACKMaN) study, we aimed to evaluate the provision of feedback by the Yorkshire Ambulance Service (YAS) research team to recruiting paramedics.
Methods: This was an observational study using a qualitative design. Data collection was conducted in January 2023 and consisted of a focus group and document analysis. The focus group lasted 1 hour and involved nine YAS research staff involved in feedback provision. Preliminary results were presented to focus group members to facilitate member checking. Reviewed documents included written feedback sent by the local research team and a standard operating procedure on incidental clinical errors. Data was analysed using the Framework Method.
Results: Research paramedics provided recruiting paramedics with feedback on ‘research study activities’ e.g. missing data, (in)-eligible patients (not) enrolled, or study protocol (not) followed. Feedback on ‘clinical practice’ not related to research activities, but incidentally discovered, were not considered within the remit of research paramedics. Barriers to effective feedback provision were the lack of awareness of recruiting paramedics that feedback would be provided and a perception that unsolicited feedback is mostly negative. Using different formats to provide feedback and engaging in a dialogue with recruiting paramedics was seen to facilitate more meaningful feedback.
Conclusions: Training for recruiting paramedics should highlight that performance and documentation will be scrutinised as part of their involvement in the clinical trial. Although flexibility of local teams regarding feedback format and delivery was important, researchers planning interventional studies in ambulance services may wish to consider the impact of different ways of working with frontline clinicians in their protocol development and study evaluation.
Methods: This was an observational study using a qualitative design. Data collection was conducted in January 2023 and consisted of a focus group and document analysis. The focus group lasted 1 hour and involved nine YAS research staff involved in feedback provision. Preliminary results were presented to focus group members to facilitate member checking. Reviewed documents included written feedback sent by the local research team and a standard operating procedure on incidental clinical errors. Data was analysed using the Framework Method.
Results: Research paramedics provided recruiting paramedics with feedback on ‘research study activities’ e.g. missing data, (in)-eligible patients (not) enrolled, or study protocol (not) followed. Feedback on ‘clinical practice’ not related to research activities, but incidentally discovered, were not considered within the remit of research paramedics. Barriers to effective feedback provision were the lack of awareness of recruiting paramedics that feedback would be provided and a perception that unsolicited feedback is mostly negative. Using different formats to provide feedback and engaging in a dialogue with recruiting paramedics was seen to facilitate more meaningful feedback.
Conclusions: Training for recruiting paramedics should highlight that performance and documentation will be scrutinised as part of their involvement in the clinical trial. Although flexibility of local teams regarding feedback format and delivery was important, researchers planning interventional studies in ambulance services may wish to consider the impact of different ways of working with frontline clinicians in their protocol development and study evaluation.
| Original language | English |
|---|---|
| Journal | British Paramedic Journal |
| Volume | 9 |
| Issue number | 4 |
| Publication status | Accepted/In press - 1 Dec 2024 |