PMID- 32477589 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220414 IS - 2055-5784 (Print) IS - 2055-5784 (Electronic) IS - 2055-5784 (Linking) VI - 6 DP - 2020 TI - Increasing uptake of structured self-management education programmes for type 2 diabetes in a primary care setting: a feasibility study. PG - 71 LID - 10.1186/s40814-020-00606-0 [doi] LID - 71 AB - BACKGROUND: Structured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An 'Embedding Package' addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach. METHODS: A concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and 'fit' of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT). RESULTS: Primary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was pound8.94, over a median follow-up of 162.5 days. Removing the development cost, this reduces to pound5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted. CONCLUSIONS: It is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT. TRIAL REGISTRATION: ISRCTN, ISRCTN21321635, Registered 07/07/2017-retrospectively registered. CI - (c) The Author(s) 2020. FAU - Davies, Melanie AU - Davies M AD - 1Diabetes Research Centre, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Kristunas, Caroline A AU - Kristunas CA AUID- ORCID: 0000-0001-8945-4671 AD - 1Diabetes Research Centre, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 AD - 2Department of Health Sciences, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Huddlestone, Lisa AU - Huddlestone L AD - 2Department of Health Sciences, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Alshreef, Abualbishr AU - Alshreef A AD - 3School of Health and Related Research, University of Sheffield, Sheffield, UK. GRID: grid.11835.3e. ISNI: 0000 0004 1936 9262 FAU - Bodicoat, Danielle AU - Bodicoat D AD - 1Diabetes Research Centre, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Dixon, Simon AU - Dixon S AD - 3School of Health and Related Research, University of Sheffield, Sheffield, UK. GRID: grid.11835.3e. ISNI: 0000 0004 1936 9262 FAU - Eborall, Helen AU - Eborall H AD - 2Department of Health Sciences, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Glab, Agnieszka AU - Glab A AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Hudson, Nicky AU - Hudson N AD - 5Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK. GRID: grid.48815.30. ISNI: 0000 0001 2153 2936 FAU - Khunti, Kamlesh AU - Khunti K AD - 1Diabetes Research Centre, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 FAU - Martin, Graham AU - Martin G AD - 6THIS Institute, University of Cambridge, Cambridge, UK. GRID: grid.5335.0. ISNI: 0000000121885934 FAU - Northern, Alison AU - Northern A AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Patterson, Mike AU - Patterson M AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Pritchard, Rebecca AU - Pritchard R AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Schreder, Sally AU - Schreder S AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Stribling, Bernie AU - Stribling B AD - 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. GRID: grid.269014.8. ISNI: 0000 0001 0435 9078 FAU - Turner, Jessica AU - Turner J AD - 5Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK. GRID: grid.48815.30. ISNI: 0000 0001 2153 2936 FAU - Gray, Laura J AU - Gray LJ AD - 2Department of Health Sciences, University of Leicester, Leicester, UK. GRID: grid.9918.9. ISNI: 0000 0004 1936 8411 LA - eng GR - RP-PG-1212-20004/DH_/Department of Health/United Kingdom PT - Journal Article DEP - 20200522 PL - England TA - Pilot Feasibility Stud JT - Pilot and feasibility studies JID - 101676536 PMC - PMC7243310 OTO - NOTNLM OT - Feasibility study OT - Structured self-management education OT - Type 2 diabetes COIS- Competing interestsThere are no conflicts of interest; however, for transparency, the following are provided: MD is the Principal Investigator (PI) on the DESMOND programme (Diabetes education and self-management for people with newly diagnosed Type 2 diabetes). BS, SS and AN are employed by the University Hospitals of Leicester NHS Trust, which receives not-for-profit income for DESMOND. MD, KK, HE, LG, AN, SS and BS are 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 and Support programmes like DESMOND. The University Hospitals of Leicester (UHL) NHS Trust (for which BS, SS and AN have a contract) receives licensing fees to support implementation of the DESMOND programme in CCGs in the UK, Ireland and Australia. All other authors have no competing interests. EDAT- 2020/06/02 06:00 MHDA- 2020/06/02 06:01 PMCR- 2020/05/22 CRDT- 2020/06/02 06:00 PHST- 2019/11/20 00:00 [received] PHST- 2020/04/22 00:00 [accepted] PHST- 2020/06/02 06:00 [entrez] PHST- 2020/06/02 06:00 [pubmed] PHST- 2020/06/02 06:01 [medline] PHST- 2020/05/22 00:00 [pmc-release] AID - 606 [pii] AID - 10.1186/s40814-020-00606-0 [doi] PST - epublish SO - Pilot Feasibility Stud. 2020 May 22;6:71. doi: 10.1186/s40814-020-00606-0. eCollection 2020.