Effectiveness of out-patient based acute heart failure care: a pilot randomised controlled trial

Abstract

Objectives

Acute heart failure (AHF) hospitalisation is associated with 10% mortality. Outpatient based management (OPM) of AHF appeared effective in observational studies. We conducted a pilot randomised controlled trial (RCT) comparing OPM with standard inpatient care (IPM).

Methods

We randomised patients with AHF, considered to need IV diuretic treatment for ≥2 days, to IPM or OPM. We recorded all-cause mortality, and the number of days alive and out-of-hospital (DAOH). Quality of life, mental well-being and Hope scores were assessed. Mean NHS cost savings and 95% central range (CR) were calculated from bootstrap analysis. Follow-up: 60 days.

Results

Eleven patients were randomised to IPM and 13 to OPM. There was no statistically significant difference in all-cause mortality during the index episode (1/11 vs 0/13) and up to 60 days follow-up (2/11 vs 2/13) [p = .86]. The OPM group accrued more DAOH {47 [36,51] vs 59 [41,60], p = .13}. Two patients randomised to IPM (vs 6 OPM) were readmitted [p = .31]. Hope scores increased more with OPM within 30 days but dropped to lower levels than IPM by 60 days. More out-patients had increased total well-being scores by 60 days (p = .04). OPM was associated with mean cost savings of £2658 (95% CR 460–4857) per patient.

Conclusions

Patients with acute HF randomised to OPM accrued more days alive out of hospital (albeit not statistically significantly in this small pilot study). OPM is favoured by patients and carers and is associated with improved mental well-being and cost savings.

Keywords:

• Acute heart failure
• cost-effectiveness
• health economics
• healthcare delivery
• heart failure
• IV diuretics

Author contributions

Wong KYK designed the study, contributed to consent, assessment and management of patients in the trial, data collection, data analysis and interpretation, and writing the paper. He is responsible for the overall content as guarantor. Hughes DA performed the exploratory cost-effectiveness analysis. Debski M contributed to consent, assessment and management of patients in the trial, data collection and data analysis and writing. Latt N contributed to data collection and data analysis, and submission of abstracts which were published in Heart Suppl 2020. Assaf O contributed to data collection for the study, in particular, cost-effectiveness data. Abdelrahman A contributed to consent, assessment and management of patients in the trial, and data collection. Taylor R performed most of the statistical analysis and writing of the results of the paper. Allgar V contributed to the statistical design of the study and generated randomisation schedule blinded to investigators and patients. McNeill L contributed to the collection and analysis of the cost-effectiveness data and critically reviewed the manuscript. Howard S contributed to the analysis of the cost-effectiveness data and critically reviewed the manuscript. Wong SYS contributed to the design of the study and critically reviewed the manuscript. Jones R is the patient public involvement group representative and critically reviewed the manuscript. Cassidy CJ contributed to the design of the study and is a Safety Committee member. Seed A contributed to the design of the study and critically reviewed the manuscript. Galasko G contributed to the design of the study and is a Safety Committee member. Clark A contributed to the design of the study and critically reviewed the manuscript. Wilson D critically reviewed the manuscript. Davis GK critically reviewed the manuscript. Montasem A critically reviewed the manuscript. Lang CC critically reviewed the manuscript. Kalra PR critically reviewed the manuscript. Campbell R critically reviewed the manuscript. Lip GYH critically reviewed the manuscript. Cleland JGF contributed to the design of the study and critically reviewed the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The study is funded by internal funding from Blackpool Teaching Hospitals NHS Foundation Trust.