Background
Self-management education and support programmes help people with type 2 diabetes to manage their diabetes better. However, most people do not attend these programmes.
Objective
Increase type 2 diabetes self-management programme attendance.
Design
Workstream 1: develop intervention (mixed methods). Workstream 2: refine intervention and trial design (feasibility study). Workstream 3: evaluate effectiveness (18-month wait-list cluster randomised controlled trial with ethnography component; baseline: months −3 to 0; step one: months 1–9; step two: months 10–18; minimum clinically significant difference in glycated haemoglobin: 1.1 mmol/mol; target sample size: 66 practices). Workstream 4: health economics analysis; 12-month observational follow-up of trial population; qualitative substudy.
Setting
Primary care practices and providers of self-management programmes (East Midlands, Thames Valley and South Midlands, Yorkshire and Humber).
Participants
Workstream 1: 103 stakeholders. Workstream 2: 6 practices. Workstreams 3–4: 64 practices (92,977 people with type 2 diabetes). Qualitative substudy: 30 participants.
Intervention
Embedding Package (marketing strategy for self-management programmes; user-friendly referral pathway; new/amended professional roles; resources toolkit) delivered through an online portal for practices and providers (‘toolkit’; 88 live accounts; average of 19 page views/week); people working with practices and providers to embed self-management programmes into routine practice (‘embedders’). Additionally, a patient digital support programme (MyDESMOND) was developed. The comparator was usual care.
Main outcome measures
Patient-level glycated haemoglobin (primary outcome, continuous, mmol/mol) and referrals to, and attendance at, self-management programmes (main secondary outcomes; binary yes/no variables) compared between control (wait-list: baseline and step one; immediate: baseline) and intervention (wait-list: step two; immediate: steps one and two) conditions.
Data sources
Existing interviews, published literature, workshops, patient-level practice data, patient self-completed questionnaire, patient-level provider data, ethnographic data and one-to-one interviews.
Results
Workstreams 1 and 2: intervention and trial successfully developed then refined.
Workstream 3: glycated haemoglobin was not significantly different (p = 0.503) between intervention and control conditions (adjusted mean difference −0.10 mmol/mol, 95% confidence interval −0.38 to 0.18; −0.01%, 95% confidence interval −0.03% to 0.02%). Both patient-level referral to, and attendance at, structured self-management education programmes were lower or similar during the intervention than control conditions. There was no significant difference in most other secondary outcomes. Prespecified analyses indicated that glycated haemoglobin was statistically significantly lower (p = 0.004) among ethnic minority individuals during intervention than control conditions (−0.64 mmol/mol, 95% confidence interval −1.08 to −0.20; −0.06%, 95% confidence interval −0.10 to −0.02). This difference was not clinically significant and self-management programme attendance did not improve. Ethnography analyses found that the intervention’s attractiveness and usefulness were not self-evident to practices and providers, much of the activity was led by the embedders, and embedders covering multiple localities were not best placed to adapt the intervention to local contexts.
Workstream 4: the intervention cost £0.52 per patient. There was no evidence of a difference in costs (−£33, 95% confidence interval −£2195 to +£2171) or quality-adjusted life-years (+0.002, 95% confidence interval −0.100 to +0.098) in the base-case analysis. The trial plus 12-month observational follow-up data showed that glycated haemoglobin was statistically significantly lower (−0.56 mmol/mol, 95% confidence interval −0.71 to −0.42; −0.05, 95% confidence interval −0.06% to −0.04%; p < 0.001) and self-management programme attendance higher (adjusted odds ratio 1.13, 95% confidence interval 1.02 to 1.25; p = 0.017) in intervention than control conditions, although it should be noted that the difference was not clinically significant. The qualitative substudy indicated that virtual programmes have a place in future self-management programme delivery, with highly positive feedback, particularly around financial and logistical benefits.
Limitations
The COVID-19 pandemic affected this research. A delayed start to the feasibility study prevented all learnings being taken into the wait-list trial, particularly around implementing the intervention at provider, not practice level. Practice engagement with the intervention was limited and variable. National Health Service commissioning restructures in England meant that, for many localities, changes to the provision of diabetes self-management programme commissioning included funding and capacity to co-ordinate and promote uptake in a similar way to the Embedding Package. With the wait-list design, a proxy primary outcome for self-management programme attendance was used, which may have affected the sensitivity of results. Finally, baseline structured self-management education programme attendance was higher than expected, and data sources were between 39% and 66% complete.
Conclusions
There were difficulties implementing the intervention, which probably contributed to the trial showing that, overall, the Embedding Package was unlikely to have affected glycated haemoglobin, self-management programme referrals and attendance or most other secondary outcomes.
Future work
Focus should be on which organisation(s)/role(s) can best drive change around embedding type 2 diabetes self-management programmes into routine care, and the role of blended face-to-face and virtual programmes.
Trial registration
This trial is registered as Current Controlled Trials ISRCTN23474120.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1212-20004) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 2. See the NIHR Funding and Awards website for further award information.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)