Successes
Successes include developing an evidence-based intervention, cohesive and inclusive public involvement, and completion of the work to time with minor adaptations given major hurdles due to COVID-19 and national restructures in logistics around recharging and organising research funding in 2018. This was one of the first programmes affected by this change.
Data collection involved co-ordinating data extraction through a third-party across practices at various time points and collecting provider data and self-report patient questionnaires via mailouts, which were linked through pseudonymised NHS numbers. To our knowledge, this is the first time that such data linkage has assessed agreement in SSME referral and attendance data demonstrating the completeness of data sources.
MyDESMOND was made available to study sites during the RCT, thereby increasing SSME availability for local populations. COVID-19 brought a greater, unintended benefit as face-to-face SSME access for people with T2DM was severely and quickly restricted. Attention on online SSME rapidly escalated and we made MyDESMOND available free of charge nationally to meet this need. Within the RCT CCGs, MyDESMOND users increased 4.2-fold from March 2020 (n = 746; when embedder activity ceased) to August 2021 (n = 3154; end of observational follow-up).
Nationally, > 25,000 diverse people have accessed MyDESMOND outside this research (46% male; 24% < 50 years; 15% ethnic minorities). MyDESMOND has a high retention rate; of those who use it for ≥ 1 day, 56% continue to use it for ≥ 3 months and 24% for ≥ 12 months (average = 107 minutes/person/week on MyDESMOND). Further evaluation of MyDESMOND is underway.
Challenges
Sustainability and transformation partnerships
After this programme began, NHS commissioning was restructured within England and sustainability and transformation partnerships introduced. These groups provide collaboration opportunities for NHS organisations and local government to identify local priorities and develop a plan to meet them. For many localities, this meant changes to diabetes SSME provision in commissioning plans, including additional funding and capacity to co-ordinate and promote uptake in a similar way to the Embedding Package, meaning that the package was sometimes deemed unnecessary. As the RCT began, it was hoped that embedders could focus on working with local CCGs and their providers to better understand current provision of diabetes SSME. However, this was not realised due to the somewhat limited impact of the embedders and the practice-level focus of the intervention implementation.
COVID-19 pandemic
When the COVID-19 pandemic started, the study sponsor paused non-COVID-19 research, leading to a rapid and significant reduction in embedding programme activity and cessation of intervention work with practices and providers. Practice and provider staff were redeployed to COVID-19 care, research and testing.
Throughout the pandemic, various options were considered to continue this project with the least disruption following the current guidance. We worked continuously with all partners and participating sites to establish which organisations could continue with the programme and in what capacity. A study extension or additional funding was not needed. A protocol amendment ensured participant and staff safety and delivery of the outcomes.
The remaining qualitative work saw the largest change. The COVID-19 outbreak led to significant changes in the landscape of group education provision, with rapidly increased demand for digital/virtual provisions, instead of face-to-face sessions. The local study team had expertise in digital programmes and qualitative work, so the involvement of another qualitative researcher was extended to conduct research into implementation of virtual self-management programmes.
The study may have had different outcomes if it were conducted outside a pandemic; however, this is unlikely, as many of the challenges/limitations were already observed before the COVID-19 pandemic.
Practice engagement
For intervention delivery, communication between practices and embedders relied almost entirely on electronic methods following initial face-to-face meetings. When this became apparently ineffective in drawing engagement from practices, phone calls were made, which also had little to no engagement as, often, the previously engaged personnel became uncontactable. This affected the ethnographic work, as low engagement made it difficult for observations and interviews to take place. It is hard to consider how this could have been overcome.
As well as the limited practice-level engagement with the intervention, there were also challenges around practice-level engagement with study activities. For example, some practices replied immediately to communications regarding study-related activities and intervention delivery, while others did not respond after multiple e-mails and phone calls.
We undertook a substantial amount of work to try and overcome the challenge of poor practice engagement with study-related activities including, but not limited to:
- Constructing a practice manager contact database to avoid delays in clinical research network contacting practices.
- Working closely with clinical research network contacts to prompt practices as necessary.
- Maintaining a careful balance of prompting practices and giving them the space that they requested to maintain GP practice retention rate.
- Providing practical support to limit practice study-related workload, such as providing prepacked questionnaire packs for mailouts.