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

Abstract

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.

Lung ultrasound-guided treatment for heart failure: An updated meta-analysis and trial sequential analysis

“…Of these studies, eight were completed and reported clinical outcomes ( 15 – 17 , 27 , 29 , 30 , 32 , 33 ). However, the other two studies were still in the process of subject enrollment ( 28 , 31 ). A total of three RCTs ( 27 , 30 , 31 ) enrolled patients with AHF, five RCTs ( 15 , 16 , 28 , 29 ) enrolled patients with CHF, and one RCT ( 30 ) enrolled patients with CHF plus pulmonary artery hypertension.…”

“…However, the other two studies were still in the process of subject enrollment ( 28 , 31 ). A total of three RCTs ( 27 , 30 , 31 ) enrolled patients with AHF, five RCTs ( 15 , 16 , 28 , 29 ) enrolled patients with CHF, and one RCT ( 30 ) enrolled patients with CHF plus pulmonary artery hypertension. Another RCT ( 33 ) enrolled subjects admitted to hospital with cardiopulmonary symptoms, nearly half of whom were diagnosed with AHF.…”

“…In six RCTs ( 15 – 17 , 27 – 29 ), the diuretic dose was modified according to the results of LUS. Meanwhile, diuretic treatment was given based on LUS and echocardiography ( 30 ), body weight ( 32 ), and inferior vena cava ultrasound ( 31 , 33 ). In the usual care group, the diuretic treatment strategy was optimized according to the results of PEs, blood tests, echocardiography, and chest X-ray in all RCTs.…”

“…However, one RCT did not report the methodological details of random sequence generation ( 30 ). A total of six studies used satisfactory methods of treatment allocation concealment ( 15 – 17 , 28 – 31 ). Blinding of participants and personnel was reported in five studies ( 15 – 17 , 28 , 29 ).…”

“…A total of three studies ( 15 , 29 , 31 ) reported the rate of patients with fewer B-lines. Overall, LUS-guided treatment was associated with a similar rate of patients with fewer B-lines (RR, 1.09; 95% CI, 0.96–1.24; p = 0.169) as usual care.…”