Evidence map›Paper›PMID 31699046›Full record

ArticleBMC family practice2019

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.

Melanie J Davies, Caroline A Kristunas, Abualbishr Alshreef, Simon Dixon, Helen Eborall, Agnieszka Glab, Lisa Huddlestone, Nicky Hudson, Kamlesh Khunti, Graham Martin and 7 more

Abstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in BMC family practice, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Educational Processes for Health and Disease Self-Management in Public Health: A Systematic Review.International journal of environmental research and public health · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Melanie J DaviesDiabetes Research Centre, University of Leicester, Leicester, UK.
Caroline A KristunasDiabetes Research Centre, University of Leicester, Leicester, UK.
Abualbishr AlshreefSchool of Health and Related Research, University of Sheffield, Sheffield, UK.
Simon DixonSchool of Health and Related Research, University of Sheffield, Sheffield, UK.
Helen EborallBiostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies Centre , University Road, Leicester, LE1 7RH, UK.
Agnieszka GlabLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Lisa HuddlestoneBiostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies Centre , University Road, Leicester, LE1 7RH, UK.
Nicky HudsonCentre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK.
Kamlesh KhuntiDiabetes Research Centre, University of Leicester, Leicester, UK.
Graham MartinTHIS Institute, University of Cambridge, Cambridge, UK.
Alison NorthernLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Mike PattersonLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Rebecca PritchardLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Sally SchrederLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Bernie StriblingLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Jessica TurnerCentre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK.
Laura J GrayBiostatistics 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.ORCID 0000-0002-9284-9321

Funding

Department of Health RP-PG-1212-20004
6 · The paper itself

Abstract

backgroundApproximately 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.

methodsA 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 registrationInternational 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.

Indexed as

AdultAnthropology, CulturalCost-Benefit AnalysisDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansInterviews as TopicMalePatient Education as TopicPrimary Health CareRandomized Controlled Trials as TopicSelf-ManagementGlycated Hemoglobinhemoglobin A1c protein, humanCluster randomised trialDiabetes educationDiabetes self-managementRandomised controlled trialSelf-managementStructured educationType 2 diabetesWait-list

Identifiers

PMID31699046
PMCPMC6839094

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.