To improve T2DM SSME uptake, an intervention that could be tailored to the local context was designed through a comprehensive, mixed-methods approach involving stakeholders. This intervention was evaluated through a feasibility study and RCT with qualitative and health economics work.
Despite initial enthusiasm for the intervention, there were implementation difficulties, partly due to embedders sitting centrally with the study team, which probably contributed to it having no effect on HbA1c or the main secondary outcomes (referrals and attendance). Other contributing factors may have been that baseline SSME attendance was higher than expected, a proxy outcome was used for the primary outcome, and COVID-19 caused all embedder activities to stop prematurely.
There were some promising results. First, HbA1c improved among ethnic minority groups during intervention conditions. This result was not clinically significant and SSME attendance did not improve so other factors likely caused the HbA1c improvement. Second, during longer-term analyses, HbA1c was (statistically but not clinically) significantly lower, and SSME attendance higher, during intervention than control conditions, suggesting that the intervention’s positive impacts and system-wide change may take longer than expected to realise. However, other external factors could have caused this improvement, such as the pandemic and the move to more online SSME. Finally, the intervention was very low cost (£0.52 per person with T2DM) and was more effective and lower cost than usual case in the base-case analyses and six out of nine scenario analyses, albeit these results were highly uncertain.
Finally, virtual SSME is acceptable to both patients and healthcare professionals, and SSME referral and attendance data are only moderately complete.