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Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic study

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posted on 2024-05-13, 11:18 authored by Melanie J Davies, Danielle H Bodicoat, Alan Brennan, Simon Dixon, Helen Eborall, Agnieszka Glab, Laura J Gray, Michelle Hadjiconstantinou, Lisa Huddlestone, Nicky Hudson, Anju Keetharuth, Kamlesh Khunti, Graham Martin, Alison Northern, Rebecca Pritchard, Sally Schreder, Jane Speight, Jackie Sturt, Jessica Turner

Background Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. ‘Embedders’ supported practices and self-management programme providers to embed programme referral into routine practice, and an online ‘toolkit’ contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months − 3–0), step one (months 1–9), step 2 (months 10–18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices’ interactions with the toolkit. Conclusions Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. Trial registration ISRCTN23474120, registered 05/04/2018.

Funding

National Institute for Health Research Programme Grants for Applied Research programme

History

Author affiliation

College of Life Sciences Population Health Sciences

Version

  • VoR (Version of Record)

Published in

BMC Primary Care

Volume

25

Issue

1

Pagination

136

Publisher

Springer Science and Business Media LLC

issn

2731-4553

eissn

2731-4553

Copyright date

2024

Available date

2024-05-13

Spatial coverage

England

Language

en

Deposited by

Professor Kamlesh Khunti

Deposit date

2024-05-13

Rights Retention Statement

  • No