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Intervening to eliminate the centre-effect variation in home dialysis use: protocol for Inter-CEPt—a sequential mixed-methods study designing an intervention bundle
  1. Maatla Tshimologo1,
  2. Kerry Allen2,
  3. David Coyle3,
  4. Sarah Damery4,
  5. Lisa Dikomitis1,5,
  6. James Fotheringham6,
  7. Harry Hill6,
  8. Mark Lambie1,
  9. Louise Phillips-Darby1,
  10. Ivonne Solis-Trapala1,
  11. Iestyn Williams2,
  12. Simon J Davies1
  1. 1 Renal Research Group, School of Medicine, Keele University, Keele, UK
  2. 2 Health Services Management Centre, University of Birmingham, Birmingham, UK
  3. 3 NIHR Devices for Dignity MedTech Co-operative, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  4. 4 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  5. 5 Kent and Medway Medical School, University of Kent, Canterbury, UK
  6. 6 School of Health and Related Research, University of Sheffield, Sheffield, UK
  1. Correspondence to Professor Simon J Davies; s.j.davies{at}


Introduction Use of home dialysis by centres in the UK varies considerably and is decreasing despite attempts to encourage greater use. Knowing what drives this unwarranted variation requires in-depth understanding of centre cultural and organisational factors and how these relate to quantifiable centre performance, accounting for competing treatment options. This knowledge will be used to identify components of a practical and feasible intervention bundle ensuring this is realistic and cost-effective.

Methods and analysis Underpinned by the non-adoption, abandonment, scale-up, spread and sustainability framework, our research will use an exploratory sequential mixed-methods approach. Insights from multisited focused team ethnographic and qualitative research at four case study sites will inform development of a national survey of 52 centres. Survey results, linked to patient-level data from the UK Renal Registry, will populate a causal graph describing patient and centre-level factors, leading to uptake of home dialysis and multistate models incorporating patient-level treatment modality history and mortality. This will inform a contemporary economic evaluation of modality cost-effectiveness that will quantify how modification of factors facilitating home dialysis, identified from the ethnography and survey, might yield the greatest improvements in costs, quality of life and numbers on home therapies. Selected from these factors, using the capability, opportunity and motivation for behaviour change framework (COM-B) for intervention design, the optimal intervention bundle will be developed through workshops with patients and healthcare professionals to ensure acceptability and feasibility. Patient and public engagement and involvement is embedded throughout the project.

Ethics and dissemination Ethics approval has been granted by the Health Research Authority reference 20-WA-0249. The intervention bundle will comprise components for all stake holder groups: commissioners, provider units, recipients of dialysis, their caregivers and families. To reache all these groups, a variety of knowledge exchange methods will be used: short guides, infographics, case studies, National Institute for Health and Care Excellence guidelines, patient conferences, ‘Getting it Right First Time’ initiative, Clinical Reference Group (dialysis).

  • Nephrology
  • Dialysis
  • End stage renal failure

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  • Contributors MT updated the literature review that informs the background to the project. KA, DC, SD, LP-D, ML, IS-T, IPW and SJD (corresponding author and CI) are all co-applicants on the original funding application, IW replacing Gill Combes (see acknowledgements) in the later stages. DC is lead for PPIE, KA and LD for work-package (WP) 1, ML and IS-T for WP 2 data analyses and SD for survey, JF and HH for WP3 and IW for WP4 and WP5. All the co-applicants and HH contributed to the finalisation of the protocol, contributing equally to the development of the manuscript and ongoing execution of the research. LP-D is responsible for overall coordination of the project and research governance.

  • Funding This project is funded by the National Institute for Health Research (NIHR) Health Services & Delivery Research (HS&DR) Programme (project reference 128364).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. This project has received research infrastructure support via the NIHR Clinical Research Network. NIHR Central Portfolio Management System (CPMS) reference 46 792.

  • Competing interests SJD (CI) receives research funding and is on an Advisory Board for Baxter Healthcare and research funding from Fresenius Medical Care (both companies deliver dialysis treatments, including home dialysis). ML receives research funding from Baxter Healthcare. JF has speaker honoraria from Fresenius medical care, consultancy fees from Novartis, travel support from Amgen, and conducts research funded by the National Institute of Health Research and the Health Foundation into in-centre haemodialysis, Kidney Research UK into peritoneal dialysis, and Vifor Pharma into pharmacotherapies for uraemic pruritus.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.