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
Abstract 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 s...
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2019-11-01
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Online Access: | http://link.springer.com/article/10.1186/s12875-019-1038-0 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Melanie J. Davies Caroline A. Kristunas Abualbishr Alshreef Simon Dixon Helen Eborall Agnieszka Glab Lisa Huddlestone Nicky Hudson Kamlesh Khunti Graham Martin Alison Northern Mike Patterson Rebecca Pritchard Sally Schreder Bernie Stribling Jessica Turner Laura J. Gray |
spellingShingle |
Melanie J. Davies Caroline A. Kristunas Abualbishr Alshreef Simon Dixon Helen Eborall Agnieszka Glab Lisa Huddlestone Nicky Hudson Kamlesh Khunti Graham Martin Alison Northern Mike Patterson Rebecca Pritchard Sally Schreder Bernie Stribling Jessica Turner Laura J. Gray 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 BMC Family Practice Type 2 diabetes Self-management Structured education Diabetes self-management Diabetes education Randomised controlled trial |
author_facet |
Melanie J. Davies Caroline A. Kristunas Abualbishr Alshreef Simon Dixon Helen Eborall Agnieszka Glab Lisa Huddlestone Nicky Hudson Kamlesh Khunti Graham Martin Alison Northern Mike Patterson Rebecca Pritchard Sally Schreder Bernie Stribling Jessica Turner Laura J. Gray |
author_sort |
Melanie J. Davies |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Family Practice |
issn |
1471-2296 |
publishDate |
2019-11-01 |
description |
Abstract 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. |
topic |
Type 2 diabetes Self-management Structured education Diabetes self-management Diabetes education Randomised controlled trial |
url |
http://link.springer.com/article/10.1186/s12875-019-1038-0 |
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doaj-a366b256e2e54eadb8a533e46a7d5c282020-11-25T04:08:01ZengBMCBMC Family Practice1471-22962019-11-0120111510.1186/s12875-019-1038-0The 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 trialMelanie J. Davies0Caroline A. Kristunas1Abualbishr Alshreef2Simon Dixon3Helen Eborall4Agnieszka Glab5Lisa Huddlestone6Nicky Hudson7Kamlesh Khunti8Graham Martin9Alison Northern10Mike Patterson11Rebecca Pritchard12Sally Schreder13Bernie Stribling14Jessica Turner15Laura J. Gray16Diabetes Research Centre, University of LeicesterDiabetes Research Centre, University of LeicesterSchool of Health and Related Research, University of SheffieldSchool of Health and Related Research, University of SheffieldBiostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies CentreLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustBiostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies CentreCentre for Reproduction Research, School of Applied Social Science, De Montfort UniversityDiabetes Research Centre, University of LeicesterTHIS Institute, University of CambridgeLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustLeicester Diabetes Centre, University Hospitals of Leicester NHS TrustCentre for Reproduction Research, School of Applied Social Science, De Montfort UniversityBiostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies CentreAbstract 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.http://link.springer.com/article/10.1186/s12875-019-1038-0Type 2 diabetesSelf-managementStructured educationDiabetes self-managementDiabetes educationRandomised controlled trial |