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Abstract
Introduction Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.
The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes.
Methods and analysis Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)—including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact.
Ethics and dissemination The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings.
Trial registration number NCT02940873; Pre-results.
- diabetes & endocrinology
- protocols & guidelines
- diabetes & endocrinology
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Twitter @TayanaSoukup
Contributors As per International Committee of Medical Journal Editors guidelines, the coauthors have contributed as following: made substantial contributions to conception and design or acquisition of data, or analysis and interpretation of data; TS, LH, IB, AH, NS, SA, ELS and PWD group been involved in drafting the manuscript or revising it critically for important intellectual content. TS, LH, IB, AH, NS, SA, ELS and PWD group given final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content; TS, LH, IB, AH, NS, SA, ELS and PWD Group agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. TS, LH, IB, AH, NS, SA, ELS and PWD Group.
Funding The funding for this study was supported by the JDRF (4-SRA-2017-266-M-N). LH, IB, SA and NS are funded by the National Institute for Health Research (NIHR) via the ‘Collaboration for Leadership in Applied Health Research and Care South London’ (CLAHRC South London) at King’s College Hospital National Health Service (NHS) Foundation Trust, London, UK. LH and NS are also funded by King’s Improvement Science, which is part of the NIHR CLAHRC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. King’s Improvement Science is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity, the Maudsley Charity and the Health Foundation. NS is also funded by the South London and Maudsley NHS Foundation Trust. IB is supported by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and by the NIHR Collaboration for Leadership in Applied Health Research and Care South London at King’s College Hospital NHS Foundation Trust, King’s College London. The funding agreements ensured the authors’ independence in designing the study, interpreting the data, writing and publishing the report.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Competing interests NS is the Director of London Safety & Training Solution, which provides advisory and training services on safety and quality improvement to hospitals and training programs internationally. TS serves as a consultant to F. Hoffmann-La Roche Diagnostics providing advisory research services in relation to innovations for multidisciplinary tumor boards. The remaining authors declare that they have no competing interests.
Patient consent for publication Not required.
Ethics approval The study described in this protocol has been reviewed and given favourable opinion by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018.
Provenance and peer review Not commissioned; externally peer reviewed.