A Template for Intervention Description and Replication description of the intervention follows. All data relate to the RCT (WS3).
Name
Embedding Package.
Why
Structured self-management education improves outcomes for people with T2DM, but SSME uptake in England remains low. This intervention aims to increase SSME uptake by embedding SSME within routine care.
What
Embedding Package
The Embedding Package comprises the components in Box 2 delivered through a new/amended role (‘embedder’) and an online portal with a range of supporting resources (‘toolkit’; see Report Supplementary Material 1). The embedder role can be described as an ‘engagement officer’; however, we named it ‘embedder’ as traditionally engagement officers focus on direct patient engagement, whereas this role focused on the organisational level.
A planned local clinical champion role was not developed due to difficulties with intervention engagement.
MyDESMOND
When this research programme started, there were no online SSME programmes meeting NICE criteria. This was deemed essential for increasing SSME uptake by offering people with T2DM a ‘menu’ of attendance options to fit their lifestyles.
Before starting this research, a prototype of a digital version of the DESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed programme, for which we hold the intellectual property) was developed. To have an online modality ready for the Embedding Package, further work was needed to refine the prototype and develop robust analytics to enable data collection on how the digital programme is used.
Consequently, this research programme developed this prototype digital programme into MyDESMOND for people with T2DM. MyDESMOND is a self-directed, web-based, interactive SSME programme based on the NICE-approved face-to-face DESMOND SSME programmes (www.mydesmond.com).
While MyDESMOND was not a formal part of the Embedding Package, it was made available to participating providers (and their patients) to increase SSME accessibility. It has also been made available nationally outside of this research programme.
Materials
The toolkit was a password-protected web-based portal for anyone involved in implementing SSME to help them consider embedding strategies, including:
- commissioners: aiding development of detail for service specifications during tendering processes
- providers (e.g. service leads, SSME educators, co-ordinators, administrators): supporting provision of SSME services across their locality
- primary care staff: providing ideas and resources on promoting their local SSME to patients.
Toolkit access was granted dependent on randomisation and login information sent directly to the relevant recipient. Additional access could be requested through a registration form. Alongside this, where it was welcomed, embedders provided an in-person guided tour of the toolkit.
The toolkit comprised three sections with a range of tools, guidance and sample resources (see Report Supplementary Material 1 for PDF version):
- How to guides: provided a wide range of strategies for increasing SSME uptake, such as carrying out a needs assessment and working with public involvement groups to adapt programmes.
- Promoting to patients: tools for designing and implementing marketing and communications plans.
- Increasing referrals: detailed activities to strengthen the referral process, such as engagement events and evaluation of existing referral pathways and administration systems.
Under ‘promoting to patients’, example patient-facing marketing materials were available to raise public awareness of SSME that could be tailored for each practice/provider. During the RCT, the following marketing materials were available (number that engaged with material):
- Sample letter templates including invitation letters with opt-in return slips (two providers).
- Promotional animation/PowerPoint® (Microsoft Corporation, Redmond, WA, USA) for waiting room television screens in practices and other waiting areas (e.g. hospitals; 34 providers/practices).
- Waiting-room display boards highlighting the patient benefits of SSME and quotes from patients who had previously taken part (49 practices).
- Banner stand (two providers) and leaflets/posters (49 providers/practices), including easy-to-read versions (one provider/6 practices), showcasing local SSME programme.
- Text and images describing the local SSME programme for the practice’s website and social media (41 practices).
- A health fair/event on World Diabetes Day (3 practices).
- Information packs for practices (49), providers (5), and pharmacists (~ 40) for World Diabetes Day and Diabetes Week, including posters, stickers and flyers designed and supplied to nearby pharmacies.
- Laminate cards for clinic spaces about local SSME and referral details (49 providers/practices).
Procedures
Two embedders were employed to liaise between stakeholders and promote toolkit use via in-person meetings, e-mail communications, telephone calls and health fair attendance. Additionally, embedders listened to practice and provider needs and suggested the introduction and designing of locally specific materials (e.g. those listed above) and liaising with providers/practices to ensure any newly designed resources were fit for purpose before organisation of production and distribution. This also meant organising, designing and delivering presentations at local faith centres to begin discussions about improving access to SSME for ethnic minority populations.
Importantly, the embedders also formed part of the intervention.
Who provided the intervention
The embedder was a new role that evolved based on experience and feedback. It was established that the embedders would require:
- detailed understanding of SSME benefits and ability to communicate this to all staff levels
- experience of quickly building and retaining strong working relationships
- knowledge of toolkit content and ability to implement this at practice and provider level.
The wide-ranging tasks associated with the embedder role are listed below.
- First point of contact for promoting diabetes education within the region.
- Designs new/adapts existing local referral pathways and reports on referral flow.
- Has a working knowledge of and fosters good working relationships with all referral sources.
- Understands the best communication channels to create a network across the region to create a sense of community.
- Understands issues relating to referral mechanisms and is the first point of contact, ensuring that concerns are alleviated.
- Promotes chosen SSME service as an integral aspect of all care pathways and offers solutions to areas of concern.
- Negotiates with patient groups on their rights to receive SSME.
- Develops and sustains good relations and buy-in with team members, stakeholder groups (including patients/service users) and on all organisational levels.
- Presents updates back to commissioners on the impact of their work.
- Prepares and distributes information back to the sources of referral so they are updated and appraised of their patients’ progress.
- Maintains oversight of the income and expenditure related to patient SSME and embedding activities to ensure that costs are within contracted value.
- Understands the value of non-cost-based activities and where costs can be saved.
- Liaises with service commissioners to negotiate on increase in referral numbers based on evidence of attendance and audit of outcomes.
- Is innovative in the approach to SSME helping commissioners to understand its and how this can help save money elsewhere across the diabetes pathway.
- Works closely with community leaders to ensure any vulnerable groups or those who disengage with other care providers are included in the offer of SSME.
- Where appropriate, assists in the recruitment of local administrator/s and champions.
- Uses the toolkit as a guide to:
- Prepare and implement local marketing and communications strategies.
- Ensure that available SSME offers are appropriate and accessible to the whole community, including any cultural adaptations required.
- Develop and maintain a locally appropriate referral pathway and administration/booking system.
- Develop locally appropriate referrer engagement materials and training events.
- Create and maintain a community awareness package.
- Develop/link and consult with existing patient and public involvement (PPI) groups and other groups for people with long-term conditions.
- Build an online and physical resource of local signposting opportunities to other available services that would support patients’ self-management.
One embedder focused on SSME providers, while the other focused on practices. While the embedders were involved with research-related activities (e.g. recording activity), they were also an integral part of the intervention and therefore most of their time was focused on intervention delivery [see Appendix 1 which includes a summary of initiatives undertaken within an embedder role (see Appendix 1, Table 3), tool articles used with an embedder (see Appendix 1, Table 4), usage data for the toolkit (see Appendix 1, Table 5) and the number of page views for the toolkit (see Appendix 1, Figure 5)]. Therefore, a separate study co-ordinator was mainly responsible for the study-related tasks.
FIGURE 2 Engagement of general practices assessed by the number of tool articles used at practice level. (Figure not reproduced here; see the original article.)
FIGURE 3 Wait-list design used in the RCT (WS3) and observational follow-up (WS4). a, Embedding Package not actively implemented by study team, but practices/providers could continue to use the Package (apart from the study-provided embedder) themselves. (Figure not reproduced here; see the original article.)
FIGURE 4 Consolidated Standards of Reporting Trials diagram (receiving the intervention was defined as participating in at least one aspect of the intervention). (Figure not reproduced here; see the original article.)
How
Initially, an embedder held a face-to-face toolkit action planning meeting with a provider representative to determine which toolkit elements could be implemented. The embedder then circulated this action plan, including assigning tasks to relevant personnel. Review meetings were scheduled to discuss progress and further tailor the intervention for each locality.
The following activities took place at provider-level (number of providers taking up each activity of eight in total):
- Expansion/addition of a digital SSME offer; MyDESMOND used in areas without online SSME (3).
- Increased focus on or instigation of self-referral mechanism (4).
- Newsletter to referrers from local provider showcasing the SSME offer, attendance figures, recent changes to the service and upcoming availability (1).
- Press releases to showcase new service elements, such as MyDESMOND and self-referral (6).
- Social media templates devised and shared with communication teams (2).
- Health stands and promotional events (2).
- Embedders provided practice feedback to providers, which increased convenient venues for group sessions (3) and alternative days/times for group sessions (3).
- Embedders began discussions regarding adapting SSME programmes to ensure they met local needs, for example, in relation to cultural adaptations (1), learning disabilities (2) and separate sessions for different age groups (1).
Actions relating to practices were disseminated by the embedder to practice staff and, in face-to-face meetings with each practice (45/66 participating practices), the embedder presented the toolkit, embedding ideas were tabled, and/or the practice received or implemented at least one patient-facing marketing material. The practice personnel that led this work varied greatly but were typically the practice manager or a practice nurse, especially those specialising in diabetes. In some practices, existing practice staff meetings were attended and a mixture of staff took part.
Where
- Face-to-face meetings: practice or provider offices.
- Toolkit: online.
- Patient-facing marketing materials: practices, pharmacies, online.
When and how much
Embedder
Embedders recorded all activities with providers and practices in ‘trackers’ (Excel®, Microsoft Corporation, Redmond, WA, USA) to inform the intervention costing (see Appendix 1). Overall, the most and least common activities were in the categories ‘promoting to patients’ (41% of activities) and ‘increasing referrals’ (3%), respectively. The most common activities with providers involved the ‘how-to’ guides (44%), and with practices involved ‘promoting to patients’ (52%).
Three articles (Top tips for marketing; Increasing practice staff engagement; Providing choice for patients) and general activity (e.g. home page) accounted for over 90% of toolkit use with the embedder (e.g. during toolkit action planning meeting). The toolkit components least engaged in with the embedder were: collect and report audit data; education champions; evaluating your programme; how to work with public involvement.
While these data indicate how the embedder part of the intervention was used, caution is required. First, an increase in activities may reflect the fact that, sometimes, embedders had to follow up more actively due to difficulties in toolkit engagement. Second, trackers only included activities involving an embedder, and providers and practices may have undertaken additional activities.
Toolkit
Appendix 1 summarises the toolkit website data. The 88 live accounts could potentially be accessed by multiple individuals. The average number of page views per week for the toolkit was 19 (including those by study staff as the data could not be separated). Figure 2 shows that most general practitioner (GP) practices used 7–12 tool articles under all initiatives.
Tailoring
The intervention was tailored to each locality through embedder meetings with practices/providers and specifically designed resources resulting from meetings and communications.
Modifications
The intervention was refined based on feasibility study learnings (WS2) before entering the RCT (WS3). Toolkit improvements included streamlining text, creating new articles and adding functionality to contact an embedder. Additionally, a ‘roles’ function (practice, provider, commissioner) was added to allow individuals to easily access relevant content. Changes were made to the embedder role, including introducing a second embedder to support implementation across practices. It was planned to focus more on providers with actions filtering down to practices, as it was understood that this would be better for instigating change. A clearer distinction was made between the study team and the embedders so that embedders could focus on toolkit implementation, rather than study-specific issues, although this continued to be problematic throughout the RCT. Other changes included naming the different meetings with providers/practices to provide clarity, improving feedback mechanisms and shortening communications to practices.
In March 2020, when the COVID-19 pandemic began, all embedder activities stopped. Practices and providers could still access the toolkit.
How well the intervention was delivered
Planned
A fidelity assessment was not planned.
Actual
Based on feasibility study learnings, it was intended that, during the RCT, the intervention would be aimed at providers and filtered down to practices. This proved difficult to implement because the RCT collected practice-level data, so embedders had to maintain a practice-level focus to ensure that their work with providers did not involve non-study practices, otherwise the effect could not be measured. The intervention in the RCT did not therefore reflect the expected real-world implementation of the intervention based on the feasibility study learnings.
Practice engagement was limited during the feasibility study and RCT (see Appendix 1). Of the 66 RCT practices, 45 had at least an initial meeting with an embedder, 17 did not engage and 4 only used waiting-area display boards. Uptake of some marketing elements was very low (e.g. two practices added details of local SSME programmes to their websites; four practices implemented the waiting room animations).