Rationale and design of a risk-guided strategy for reducing readmissions for acute decompensated heart failure: the Risk-HF study

Aims: Heart failure (HF) readmission commonly arises owing to insufficient patient knowledge and failure of recognition of the early stages of recurrent fluid congestion. In previous work, we developed a score to predict short-term hospital readmission and showed that higher-risk patients benefit most from a disease management programme (DMP) that included enhancing knowledge and education by a nurse. We aim to evaluate the effectiveness of a novel, nurse-led HF DMP in selected patients at high risk of short-term hospital readmission, using ultrasound-guided diuretic management and artificial intelligence to enhance HF knowledge in an outpatient setting. Methods and results: Risk-HF is a prospective multisite randomized controlled trial that will allocate 404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30 days, into risk-guided nurse intervention (DMP-Plus group) compared with usual care. Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based ‘digital health coach’; and (vi) exercise guidance through the digital coach. Usual care involves standard post-discharge hospital care. The primary outcome is reduced death and/or hospital readmissions at 30 days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement. Assuming that our intervention will reduce readmissions and/or deaths by 50%, with a 1:1 ratio of intervention vs. usual care, we plan to randomize 404 patients to show a difference at a statistical power of 80%, using a two-sided alpha of 0.05. We anticipate this recruitment will be achieved by screening 2020 hospitalized HF patients for eligibility. An 8 week pilot programme of our digital health coach in 21 HF patients, age ' 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21). A pilot of the use of HHU by nurses showed that it was feasible and accurate. Conclusions: The Risk-HF trial will evaluate the effectiveness of a risk-guided intervention to improve HF outcomes and will evaluate the efficacy of trained HF nurses delivering a fluid management protocol that is guided by lung ultrasound with an HHU at point of care.