Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide

• Published in: BMJ open Vol. 14; no. 1; p. e080410
• Main Authors: Chen, Yang, Shah, Anoop, Jani, Yogini, Higgins, Daniel, Saleem, Nausheen, Chafer, Kris, Sydes, Matthew Robert, Asselbergs, Folkert W, Lumbers, R Thomas
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 11-01-2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Cardiovascular Medicine; Clinical medicine; Consent; Correspondence; Critical care; Electronic Health Records; Fasting; Feasibility Studies; Furosemide - therapeutic use; Heart failure; Heart Failure - drug therapy; Hospitalization; Hospitals; Humans; Intervention; Patients; Physicians; Randomized Controlled Trial; Randomized Controlled Trials as Topic; Sample Size; Heart failure; Randomized Controlled Trial; Electronic Health Records; Feasibility Studies
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-080410

IntroductionAcute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct to pharmacological therapy with loop diuretics, but there is a lack of evidence from traditional randomised controlled trials (RCTs) to support the safety and effectiveness of this intervention in the acute setting.This study aims to explore the feasibility of using computer alerts within the electronic health record (EHR) system to invite clinical care teams to enrol patients into a pragmatic RCT at the time of clinical decision-making. It will additionally assess the effectiveness of using an alert to help address the clinical research question of whether oral fluid restriction is a safe and effective adjunct to pharmacological therapy for patients admitted with fluid overload.Methods and analysisTHIRST (Randomised Controlled Trial within the electronic Health record of an Interruptive alert displaying a fluid Restriction Suggestion in patients with the treatable Trait of congestion) Alert is a single-centre, parallel-group, open-label pragmatic RCT embedded in the EHR system that will be conducted as a feasibility study at an National Health Service (NHS) hospital in London. The clinical care team will be invited to enrol suitable patients in the study using a point-of-care alert with a target sample size of 50 patients. Enrolled patients will then be randomised to either restricted or unrestricted oral fluid intake. Two primary outcomes will be explored (1) the proportion of eligible patients enrolled in the study and (2) the mean difference in oral fluid intake between randomised groups. A series of secondary outcomes are specified to evaluate the effectiveness of the alert, adherence to the randomised treatment allocation and the quality of data generated from routine care, relevant to the outcomes of interest.Ethics and disseminationThis study was approved by Riverside Research Ethics Committee (Ref: 22/LO/0889) and will be published on completion.Trial registration numberNCT05869656.