RATIONALE: Engaging patients and HCPs in effectiveness research is challenging. Unusually, most GP practices and pharmacies in Salford, and many in surrounding areas, participated in the COPD and asthma SLS - two randomized, controlled, effectiveness trials conducted in UK primary care. In SLS, study visits/interventions were minimal and patient recruitment, day-to-day care, and medicines supply was via patients’ usual GP and community pharmacist. We aimed to understand the drivers for patient and HCP engagement in SLS and how participation in future effectiveness trials might be enhanced.
METHODS: Purposive sampling was used to recruit patients, GPs, and PMs who participated in SLS. Patients underwent semi-structured telephone interviews. Face-to-face advisory boards were held with GPs and PMs (plus one telephone interview). These were audio-recorded and thematic analysis conducted.
RESULTS: Ten patients (7M/3F) were interviewed (3 COPD, 65-84yrs; 7 asthma, 18-74yrs). Overall, patient experience was positive; 50% expressed no negative experiences, others reported minor criticisms, e.g. not receiving trial medication or study results and lack of local pharmacist involvement. Key positive SLS features included relationships with research nurses, ease/convenience of study assessments, and free on-study prescriptions. All patients would participate in comparable trials and most would encourage others to participate. Key drivers for future participation included perceived benefit, study design/logistics, and disease severity status. Nine GPs (8M/1F) reported an overall positive experience, noting research nurse support as a key aspect. Challenges included difficulties with medication ordering, burden/time constraints for eCRF safety reporting, and high research nurse turnover. GPs preferred to receive study results via workshops/meeting(s) than written format. GP-perceived barriers to further results dissemination to practices/patients included time/resource constraints and perceived lack of patient interest. Seven PMs (2M/5F) reported key drivers for practice participation including potential patient benefit, financial benefit to practice, and involvement in a large, novel study. Overall, PMs were impressed with SLS implementation/delivery, attributing this primarily to research nurse involvement. PMs noted operational challenges including managing patient reimbursement, prescription generation, and invoicing. GPs/PMs expressed interest in participating in future trials if the design, funding, and research nurse support were similar to SLS.
CONCLUSIONS: Key features associated with the success of SLS that should be considered when designing future pragmatic real-world effectiveness studies are ensuring the study design and delivery is aligned with routine care, ease/convenience of study assessments, and the provision of research nurse support. Enhancing strategies for results dissemination was a notable area for development.
