Is there enough uncertainty regarding safety of management of decompensated heart failure at home to justify a multicentre trial? the safe@home-hf survey

Introduction In 2022, 9.7% of patients with acute decompensated heart failure (DHF) received intravenous (IV) diuretics via outpatient-based management (OPM) at home, in community settings, or hospital furosemide lounges. The effectiveness of OPM has largely been based on observational studies. Our UK pilot randomised trial showed OPM increased days alive out of hospital, but there is concern over a higher rate of hospitalisation by 60 days. Purpose The Safe@Home-HF Survey aims to assess whether there is enough uncertainty regarding safety of OPM to justify a multicentre randomised controlled trial (RCT). Methods A survey was sent to >55 organisations managing DHF across the UK by the NIHR Regional Research Delivery Network Study Support Service, via the British Society for Heart Failure and Safe@Home-HF investigators. Questions addressed OPM service availability and whether there is sufficient uncertainty regarding safety to justify an RCT of OPM care. Participants were asked to consider examples of equipoise (uncertainty regarding safe discharge), rating the likelihood of patients being safely managed at home. Clinical scenarios were scored on a five-point Likert scale (1=very likely unsafe, 3=equipoise, 5=very likely safe). Analysis: Likert scale responses were presented as median [interquartile range] to assess the degree of clinical uncertainty. Results Consultants and nurses from 42 sites responded. Thirty-one (74%) offered OPM, with 13% (2934/22567) of patients receiving outpatient IV diuretics annually. Safety perceptions varied, with clinical scenario scores ranging from ‘’very likely unsafe” to “very likely safe” (1-5) for all but the highest risk cases (1-4). This variability underscores the lack of consensus on OPM safety [Table and Figure]. There was a wide spectrum of opinion regarding whether the consultant or nurse would consider OPM to be a safe management strategy even for patients who would have been excluded in our pilot single-centre trial. [Features highlighted with grey-shading in Table]. 76% (32/42) of respondents reported sufficient uncertainty regarding safety to justify an RCT of home care. Most centres (91%) expressed interest in participating in an RCT, and feasibility of patient recruitment to the RCT (2-5 patients per-month per site). In addition, median 5 [2, 16] patients per-month per site can be enrolled into a registry for patients who meet eligibility criteria but choose not to be randomised or cannot be randomised due to organisational factors (e.g. no bed). Conclusions More than three-quarters of survey respondents reported enough uncertainty regarding safety of outpatient delivery of IV diuretics for heart failure to justify an RCT. However, opinion varied widely regarding the safety of OPM for selected patients.