Barriers to successful implementation of care in home haemodialysis (BASIC-HHD):1. Study design, methods and rationale

Background: Ten years on from the National Institute of Health and Clinical Excellence' technology appraisal guideline on haemodialysis in 2002; the clinical community is yet to rise to the challenge of providing home haemodialysis (HHD) to 10-15% of the dialysis cohort. The renal registry report, suggests underutilization of a treatment type that has had a lot of research interest and several publications worldwide on its apparent benefit for both physical and mental health of patients. An understanding of the drivers to introducing and sustaining the modality, from organizational, economic, clinical and patient perspectives is fundamental to realizing the full benefits of the therapy with the potential to provide evidence base for effective care models. Through the BASIC-HHD study, we seek to understand the clinical, patient and carer related psychosocial, economic and organisational determinants of successful uptake and maintenance of home haemodialysis and thereby, engage all major stakeholders in the process. Design and methods: We have adopted an integrated mixed methodology (convergent, parallel design) for this study. The study arms include a. patient; b. organization; c. carer and d. economic evaluation. The three patient study cohorts (n = 500) include pre-dialysis patients (200), hospital haemodialysis (200) and home haemodialysis patients (100) from geographically distinct NHS sites, across the country and with variable prevalence of home haemodialysis. The pre-dialysis patients will also be prospectively followed up for a period of 12 months from study entry to understand their journey to renal replacement therapy and subsequently, before and after studies will be carried out for a select few who do commence dialysis in the study period. The process will entail quantitative methods and ethnographic interviews of all groups in the study. Data collection will involve clinical and biomarkers, psychosocial quantitative assessments and neuropsychometric tests in patients. Organizational attitudes and dialysis unit practices will be studied together with perceptions of healthcare providers on provision of home HD. Economic evaluation of home and hospital haemodialysis practices will also be undertaken and we will apply scenario (what ... if) analysis using system dynamics modeling to investigate the impact of different policy choices and financial models on dialysis technology adoption, care pathways and costs. Less attention is often given to the patient's carers who provide informal support, often of a complex nature to patients afflicted by chronic ailments such as end stage kidney disease. Engaging the carers is fundamental to realizing the full benefits of a complex, home-based intervention and a qualitative study of the carers will be undertaken to elicit their fears, concerns and perception of home HD before and after patient's commencement of the treatment. The data sets will be analysed independently and the findings will be mixed at the stage of interpretation to form a coherent message that will be informing practice in the future. Discussion: The BASIC-HHD study is designed to assemble pivotal information on dialysis modality choice and uptake, investigating users, care-givers and care delivery processes and study their variation in a multi-layered analytical approach within a single health care system. The study results would define modality specific service and patient pathway redesign. Study Registration: This study has been reviewed and approved by the Greater Manchester West Health Research Authority National Research Ethics Service (NRES) The study is on the NIHR (CLRN) portfolio.