PMID- 31699046
OWN - NLM
STAT- MEDLINE
DCOM- 20200611
LR  - 20221207
IS  - 1471-2296 (Electronic)
IS  - 1471-2296 (Linking)
VI  - 20
IP  - 1
DP  - 2019 Nov 7
TI  - The impact of an intervention to increase uptake to structured self-management 
      education for people with type 2 diabetes mellitus in primary care (the embedding 
      package), compared to usual care, on glycaemic control: study protocol for a 
      mixed methods study incorporating a wait-list cluster randomised controlled 
      trial.
PG  - 152
LID - 10.1186/s12875-019-1038-0 [doi]
LID - 152
AB  - BACKGROUND: Approximately 425 million people globally have diabetes, with ~ 90% 
      of these having Type 2 Diabetes Mellitus (T2DM). This is a condition that leads 
      to a poor quality of life and increased risk of serious health complications. 
      Structured self-management education (SSME) has been shown to be effective in 
      improving glycaemic control and patient related outcome measures and to be 
      cost-effective. However, despite the demonstrated benefits, attendance at SSME 
      remains low. An intervention has been developed to embed SSME called the 
      'Embedding Package'. The intervention aims to address barriers and enhance 
      enablers to uptake of SSME at patient, healthcare professional and organisational 
      levels. It comprises a marketing strategy, user friendly and effective referral 
      pathways, new roles to champion SSME and a toolkit of resources. METHODS: A mixed 
      methods study incorporating a wait-list cluster randomised trial and ethnographic 
      study, including 66 UK general practices, will be conducted with two intervention 
      start times (at 0 and 9 months), each followed by an active delivery phase. At 
      18 months, the intervention will cease to be actively delivered and a 12 month 
      observational follow-up phase will begin. The intervention, the Embedding 
      Package, aims to increase SSME uptake and subsequent improvements in health 
      outcomes, through a clear marketing strategy, user friendly and effective 
      referral pathways, a local clinical champion and an 'Embedder' and a toolkit of 
      resources for patients, healthcare professionals and other key stakeholders. The 
      primary aim is, through increasing uptake to and attendance at SSME, to reduce 
      HbA1c in people with T2DM compared with usual care. Secondary objectives include: 
      assessing whether there is an increase in referral to and uptake of SSME and 
      improvements in biomedical and psychosocial outcomes; an assessment of the 
      sustainability of the Embedding Package; contextualising the process of 
      implementation, sustainability of change and the 'fit' of the Embedding Package; 
      and an assessment of the cost-effectiveness of the Embedding Package. DISCUSSION: 
      This study will assess the effectiveness, cost-effectiveness and sustainability 
      of the Embedding Package, an intervention which aims to improve biomedical and 
      psychosocial outcomes of people with T2DM, through increased referral to and 
      uptake of SSME. TRIAL REGISTRATION: International Standard Randomised Controlled 
      Trials Number ISRCTN23474120. Assigned 05/04/2018. The study was prospectively 
      registered. On submission of this manuscript practice recruitment is complete, 
      participant recruitment is ongoing and expected to be completed by the end of 
      2019.
FAU - Davies, Melanie J
AU  - Davies MJ
AD  - Diabetes Research Centre, University of Leicester, Leicester, UK.
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Kristunas, Caroline A
AU  - Kristunas CA
AD  - Diabetes Research Centre, University of Leicester, Leicester, UK.
AD  - Biostatistics Research Group, Department of Health Sciences, College of Life 
      Sciences, University of Leicester, George Davies Centre , University Road, 
      Leicester, LE1 7RH, UK.
FAU - Alshreef, Abualbishr
AU  - Alshreef A
AD  - School of Health and Related Research, University of Sheffield, Sheffield, UK.
FAU - Dixon, Simon
AU  - Dixon S
AD  - School of Health and Related Research, University of Sheffield, Sheffield, UK.
FAU - Eborall, Helen
AU  - Eborall H
AD  - Biostatistics Research Group, Department of Health Sciences, College of Life 
      Sciences, University of Leicester, George Davies Centre , University Road, 
      Leicester, LE1 7RH, UK.
FAU - Glab, Agnieszka
AU  - Glab A
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Huddlestone, Lisa
AU  - Huddlestone L
AD  - Biostatistics Research Group, Department of Health Sciences, College of Life 
      Sciences, University of Leicester, George Davies Centre , University Road, 
      Leicester, LE1 7RH, UK.
FAU - Hudson, Nicky
AU  - Hudson N
AD  - Centre for Reproduction Research, School of Applied Social Science, De Montfort 
      University, Leicester, UK.
FAU - Khunti, Kamlesh
AU  - Khunti K
AD  - Diabetes Research Centre, University of Leicester, Leicester, UK.
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Martin, Graham
AU  - Martin G
AD  - THIS Institute, University of Cambridge, Cambridge, UK.
FAU - Northern, Alison
AU  - Northern A
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Patterson, Mike
AU  - Patterson M
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Pritchard, Rebecca
AU  - Pritchard R
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Schreder, Sally
AU  - Schreder S
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Stribling, Bernie
AU  - Stribling B
AD  - Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, 
      Leicester, UK.
FAU - Turner, Jessica
AU  - Turner J
AD  - Centre for Reproduction Research, School of Applied Social Science, De Montfort 
      University, Leicester, UK.
FAU - Gray, Laura J
AU  - Gray LJ
AUID- ORCID: 0000-0002-9284-9321
AD  - Biostatistics Research Group, Department of Health Sciences, College of Life 
      Sciences, University of Leicester, George Davies Centre , University Road, 
      Leicester, LE1 7RH, UK. Lg48@le.ac.uk.
LA  - eng
SI  - ISRCTN/ISRCTN23474120
GR  - RP-PG-1212-20004/DH_/Department of Health/United Kingdom
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191107
PL  - England
TA  - BMC Fam Pract
JT  - BMC family practice
JID - 100967792
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Anthropology, Cultural
MH  - Cost-Benefit Analysis
MH  - Diabetes Mellitus, Type 2/economics/*therapy
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Interviews as Topic
MH  - Male
MH  - Patient Education as Topic/*methods
MH  - Primary Health Care/economics/*methods
MH  - Self-Management/economics/*methods
PMC - PMC6839094
OTO - NOTNLM
OT  - Cluster randomised trial
OT  - Diabetes education
OT  - Diabetes self-management
OT  - Randomised controlled trial
OT  - Self-management
OT  - Structured education
OT  - Type 2 diabetes
OT  - Wait-list
COIS- Conflicts of interest: We do not hold any conflicts of interest, however, for 
      transparency we provide the following statement of conflict: MJD 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. MJD, 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- 2019/11/09 06:00
MHDA- 2020/06/12 06:00
PMCR- 2019/11/07
CRDT- 2019/11/09 06:00
PHST- 2019/10/04 00:00 [received]
PHST- 2019/10/17 00:00 [accepted]
PHST- 2019/11/09 06:00 [entrez]
PHST- 2019/11/09 06:00 [pubmed]
PHST- 2020/06/12 06:00 [medline]
PHST- 2019/11/07 00:00 [pmc-release]
AID - 10.1186/s12875-019-1038-0 [pii]
AID - 1038 [pii]
AID - 10.1186/s12875-019-1038-0 [doi]
PST - epublish
SO  - BMC Fam Pract. 2019 Nov 7;20(1):152. doi: 10.1186/s12875-019-1038-0.