Title: Personalising renal function monitoring and interventions in people living with heart failure: RENAL-HF
Funder: Department of Health and Social Care

Abstract: Background Modern heart failure treatment has reduced morbidity and improved survival, but people with heart failure remain at risk of renal deterioration. This is potentially preventable through regular renal function monitoring and optimisation of drug dose/choice. Currently, healthcare professionals treating people with heart failure lack evidence-based guidance on how frequently to monitor renal function and on the best way to adjust drug dose/choice for each individual. We hypothesise that the lack of clear, personalised guidance contributes to renal deterioration and hospitalisation in people with heart failure. In preliminary work we: 1) showed there is enormous variability in care of people with heart failure and 2) created an algorithm to predict renal function change using electronic health record data. Aims and Objectives We shall develop an evidence-based system for generating guidelines for personalised renal function monitoring and treatment embedded within standard software used by primary care practitioners. We shall: Refine the accuracy of the algorithm that predicts the change in renal function in people with heart failure; Co-create with patients, primary care practitioners and specialists the clinical pathway for implementing personalised renal function monitoring and interventions; Assess the clinical effectiveness of our algorithm-guided clinical pathway, compared with current standard-of-care, in a cluster randomised controlled trial embedded within the Clinical Practice Research Datalink (CPRD); Perform health economic analysis to determine the cost-effectiveness of our algorithm-guided clinical pathway; Ensure that the patient voice is integrated throughout our studies and outputs. Methods We shall refine our algorithm using statistical and deep-learning methods and co-design algorithm-informed decision making with specialists (identifying the best algorithm and defining personalised renal function monitoring frequencies and thresholds for altering medication). We shall reach consensus using the RAND/UCLA Appropriateness Method. The algorithm will be embedded into software in collaboration with CPRD and the software provider. We shall establish patient and practitioner views on usual care using surveys, and structured and 'think aloud' interviews. This will inform workshops to co-create the implementation pathway with patients, practitioners and specialists. We shall use the behaviour change wheel, the non-adoption, abandonment, scale-up, spread, sustainability framework and the Health Inequalities Assessment Tool to support implementation. Implementation will be beta-tested in five general practices and acceptability evaluated using quantitative data and qualitative interviews. Our intervention will be tested in a randomised controlled trial delivered through CPRD. The number of people living with heart failure hospitalised due to renal deterioration/injury will be compared between 100 practices using our intervention and 100 control practices. Patient-acceptability and benefits will be evaluated using the EQ-5D-5L survey. Health economic analysis will determine the lifetime incremental costs and Quality Adjusted Life Years of implementing the renal function monitoring algorithm compared with usual care. Impact We estimate that 27,500 people with heart failure are admitted to hospital due to renal impairment caused by medication per year in England. Evan a 5% decrease in hospital admission would correspond to 1,375 admissions avoided per year. We will engage with primary care system providers and policy makers early in the project to facilitate scale-up UK wide.

Lay abstract: Background Almost a million people in the UK live with heart failure, most of whom also have kidney problems. The heart and kidneys strongly affect each other. If the heart suddenly works less well, kidney function can worsen. Modern treatments help people with heart failure to live longer, healthier lives but the amount and type of their medication need to be checked regularly. Too low a dose of heart medication makes heart failure symptoms worse. Higher doses of heart medication can make kidney function worse. Either can lead to hospitalization and increase the risk of death. At present, the frequency of blood tests to measure kidney function varies widely between GPs. Individuals respond differently to changes in medicines and there is no way to work out how often a kidney blood test is required. If tests are not frequent enough, worsening in kidney function might not be detected early, risking hospitalisation. Others might have more tests than needed, causing inconvenience. Aims We aim to improve kidney health in people living with heart failure. We shall develop technology to predict how often each person with heart failure needs a kidney blood test. We shall produce expert advice for GPs and nurses on how to adjust medicine dose and/or type to keep both the heart and kidneys working together at their best. Design and methods We shall use medical records to predict how an individual's kidney function will change over time, allowing us to recommend how often each person should be tested. We shall combine this with treatment advice in an 'alert' message sent to GPs via their computer system. Working with doctors and nurses will help us understand how to make these alerts user friendly. We shall test our alerts in 100 general practices to discover whether they improve kidney health in people with heart failure and are cost-effective for the NHS. Patient and Public Involvement (PPI) Our public co-applicant has lived experience of heart failure and will co-lead our PPI group. We shall recruit and train a 12-strong group to work closely with researchers, to ensure that changes to healthcare as a result of this project are supported by people living with heart failure. The group will take active roles in the work, including input into development of the alert and co-developing surveys, training materials and plain language summaries. Sharing our Work We will use social media and our website to reach the public, links to groups such as the Royal Colleges of Physicians to reach healthcare professionals and networks such as the North West Coast Applied Research Collaborative for researchers. Members of PPI group will be Ambassadors for the project, presenting the work across patient support groups and charities.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.2 HEALTH AND WELFARE ECONOMICS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR;RENAL AND UROGENITAL