Reducing the impact of diabetic foot ulcers on patients and the health service: the REDUCE programme

Question: Can we reduce the impact and costs of diabetic foot ulcers (DFUs) on patients and the NHS, through a complex intervention which targets the psychological/behavioural risk factors associated with ulcer recurrence and healing? Background: One in 17 people in the UK has diabetes. DFUs are common, chronic and costly complications of the disease: affecting 25% of patients, less than half of whom will be ulcer-free after 6 months of treatment. The physical and emotional burden is also considerable: 32% of patients are depressed and this is related to a 3-fold greater risk of mortality. In 2014-15, the NHS spent approximately £1 billion on diabetic foot care. Previous ulceration is the single greatest risk factor for ulceration: with 40% of patients re-ulcerating within 12 months. NICE guidance on the management of these high-risk patients has significant limitations; relying on referral to foot-protection teams and education . However education is not defined and recommended on the basis of expert opinion not research. Indeed, successive systematic reviews indicate education alone does not improve clinical outcomes. Furthermore, the guidance neglects psychological/behavioural risk factors, despite evidence they play a role. We have previously developed a complex intervention (REDUCE) which targets the psychological/behavioural risk-factors associated with DFU recurrence and healing. This requires evaluation. In addition, we have identified that patients would welcome an additional digital intervention to support long-term change in these risk factors. Thus, this programme aims to: Develop the REDUCE digital intervention and training programme; Test the intervention and trial procedures in a pilot trial; Evaluate whether and how REDUCE works; Determine if it is cost-effective; Identify the patient and NHS factors which could influence how REDUCE is implemented. Methods: The programme involves 6 work-packages (WPs). WP1 will take a person-based approach to intervention development; and the training programme will be developed in conjunction with our PPI group. The pilot trial (WP2) will use qualitative methods to explore whether REDUCE, the training programme, logic model or intervention fidelity tool need refining; and will monitor recruitment, questionnaire completion rates and outcome data capture. The main trial (WP3) will measure whether REDUCE significantly increases ulcer-free days in patients at risk of re-ulceration. A mixed-methods process evaluation will examine how REDUCE works, for whom and intervention fidelity (WP4). WP5 will assess cost-effectiveness. WP6a will survey providers and commissioners to explore perceived barriers and facilitators to offering REDUCE. Predictive computer modelling will examine who benefits most from REDUCE and in what ways (WP6b). Timelines: A 72 month programme: development work (WPs1&2) occurring during 0-21m; main trial (WP3) and WP4 over 22-66m (analyses and dissemination 67-72m); WP5&6 running across the programme. Impact/Dissemination: If REDUCE is effective, a 15% increase in the number of patients who are ulcer-free could save the NHS £105 million per annum. The findings could also trigger a paradigm shift in the management of DFUs and other chronic conditions by demonstrating how modifying psychological/behavioural risk factors can improve outcomes for patients and the NHS. We will share findings with patient, academic, clinical and commissioning audiences.