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Randomized Controlled Trial
. 2025 Feb 11;15(2):e093327.
doi: 10.1136/bmjopen-2024-093327.

A model based cost-utility analysis of Embedding referral to structured self-management education into standard practice (Embedding) compared to usual care for people with type 2 diabetes diagnosis in the last 12 months in England

Affiliations
Randomized Controlled Trial

A model based cost-utility analysis of Embedding referral to structured self-management education into standard practice (Embedding) compared to usual care for people with type 2 diabetes diagnosis in the last 12 months in England

Daniel John Pollard et al. BMJ Open. .

Abstract

Objectives: To conduct a cost-utility analysis of an implementation package that has been developed aiming to embed the referral of people with type 2 diabetes mellitus (T2DM) to structured self-management education (SSME) from primary care into routine practice compared with usual care.

Design: Model-based cost-effectiveness analysis using the School for Public Health Research type 2 diabetes treatment model. With costs and effectiveness parameters coming from analyses of data from a cluster randomised control trial.

Setting: English National Health Service.

Participants: People with T2DM from 64 GP practices in England.

Interventions: Embedding SSME implementation package Usual care.

Primary and secondary outcome measures: The primary outcome measure was the incremental cost-effectiveness ratio. Secondary outcome measures included the probability of Embedding implementation package being cost-effective and value of information.

Results: The estimated cost of the intervention was £40 316 across the study sites, which equates to £0.521 per patient across all practices. For the base case, the estimated mean discounted incremental lifetime cost of the intervention per patient is £48.19. This is associated with a mean per patient incremental quality-adjusted life-year (QALY) estimate of 0.006, producing an incremental cost-effectiveness ratio of £8311 per QALY gained. This has a 73.1% probability of the intervention being cost-effective at a funding threshold of £20 000 per QALY gained. Scenario analyses indicate that alternative parameterisations can lead to this finding being overturned.

Conclusions: The effectiveness of the Embedding packages was hampered by the COVID-19 pandemic. However, our base case analysis shows that Embedding could be cost-effective for this patient population, but this was subject to significant structural uncertainty. This suggests that while implementation initiatives can be highly cost-effective in this population, more robust evidence or further incentivisation will be required before widespread adoption can be recommended.

Trial registration number: ISRCTN23474120, registered 05/04/2018.

Keywords: Diabetes Mellitus, Type 2; HEALTH ECONOMICS; Health Education; Primary Care.

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Conflict of interest statement

Competing interests: DP and AB worked on the Hypo-RESOLVE project, which received in kind support from Novo Nordisk A/S, Eli Lilly and Company Limited, Abbott Diabetes Care, Medtronic and Sanofi (who left the project in 2020). DP has received personal fees from Novo Nordisk. AB reports consulting fees from Eli Lilly, BMS and Sanofi. MH is actively engaged in research and have previously received grants for DESMOND from NIHR, MRC and Diabetes UK to develop and test diabetes self-management education programmes like DESMOND and myDESMOND. DB is an independent consultant contracted by the University of Leicester. MD has received contracts, personal fees or support for attending meetings or participating on a Data Safety Monitoring Board or Advisory Board from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Janssen, Sanofi-Aventis, Eli Lilly, Napp Pharmaceuticals, Amgen, Carmot/Roche, Pfizer and Zealand Pharma. AK, AG, JM, AN report no conflicts of interest.

Figures

Figure 1
Figure 1. Cost-effectiveness plane for base case PSA and scenario analysis results.

References

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