THIRST Alert Trial

NCT05869656 | Completed

• 1 other identifier: 151938
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this feasibility study is to determine whether an alert embedded within the electronic health record (EHR) causes clinicians to enrol patients into a randomised controlled trial (RCT) comparing oral fluid restriction versus no restriction in patients admitted to hospital with fluid overload. One of the main causes of fluid overload is heart failure where there is a lack of strong evidence to support the effectiveness of oral fluid restriction in the acute setting. This causes significant variation in clinical practice where decisions on whether or not to impose a restriction in oral fluid intake is based on the preference of the treating clinician rather than robust evidence from research. THIRST Alert is a pragmatic randomised controlled trial (RCT), embedded in the EHR, which seeks to determine whether a computerised alert for the clinical team can change clinician behaviour during routine NHS care at University College London Hospitals NHS Foundation Trust (UCLH). Patients with suspected fluid overload will be identified based on the prescription of intravenous furosemide, a medication used to stimulate diuresis (increased urine output) to remove excess fluid. A repeat prescription of intravenous furosemide within the first 48 hours of an unplanned admission will trigger the alert. A clinician from the treating team will then be asked to consider enrolling the patient into the RCT if they judge that oral fluid restriction might be beneficial but they have uncertainty about this (clinical equipoise). Enrolled patients will be randomised to either oral fluid restriction of 1 litre per day or no fluid restriction. This will then be actioned through documenting as part of the clinical plan in the patients record and then communicated to the patient and the rest of the clinical team, including nursing staff. The study will record the number of patients recruited into the trial and the effect of the alert on enrolled patients' subsequent oral fluid intake. There are no additional tests or follow up for patients and the trial finishes on discharge from the study site. All trial outcomes will use data collected from routine care and the study is supported by the UCLH Biomedical Research Centre, funded by NIHR.

Conditions

Fluid Overload; Congestive Heart Failure

Keywords

Electronic health record; Comparative effectiveness research; Pragmatic trial; Learning health systems; Heart Failure; Treatable trait

Outcome Measures

Primary Outcomes (2)

• Number of patients recruited into the trial

  The number of patients in which the usual care team thought there was equipoise for oral fluid restriction

  3 months

• Difference in oral fluid intake between intervention and control arms

  Difference in documented oral intake (ml)

  48 hours after randomisation

Secondary Outcomes (10)

• Adherence to randomised alert recommendation

  During trial recruitment window (up to day 2)

• Proportion of alerts with clinical orders for nursing staff

  During trial recruitment window (up to day 2)

• Oral fluid intake

  From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date

• Net fluid balance

  From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date

• Weight change after randomisation

  48 hours after randomisation

Study Arms (2)

Alert recommending oral fluid restriction

EXPERIMENTAL

The alert will suggest to the treating clinician to fluid restrict the patient to 1L of oral fluid per day

Behavioral: Fluid restriction

Alert recommending no oral fluid restriction

ACTIVE COMPARATOR

The alert will suggest to the treating clinician to continue without any oral fluid restriction

Behavioral: Free fluids

Interventions

Fluid restriction BEHAVIORAL

Oral fluid restriction of 1000ml per day

Alert recommending oral fluid restriction

Free fluids BEHAVIORAL

Continue care without any oral fluid restriction

Alert recommending no oral fluid restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prescribed IV furosemide during the first 48h of their admission as a regular prescription rather than a one-off dose.

You may not qualify if:

• On a surgical, obstetric or critical care ward environment
• Patients who opt out of study

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals (UCLH) NHS Foundation Trust: collaborator
• National Institute for Health and Care Research (NIHR) UCLH Biomedical Research Centre: collaborator

Study Sites (1)

University College Hospital

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

• Chen Y, Shah A, Jani Y, Higgins D, Saleem N, Chafer K, Sydes MR, Asselbergs FW, Lumbers RT. 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. BMJ Open. 2024 Jan 11;14(1):e080410. doi: 10.1136/bmjopen-2023-080410.

  PMID: 38216198 DERIVED

MeSH Terms

Conditions

Edema; Heart Failure

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yang Chen, BMBCh, MSc

  UCL

  PRINCIPAL INVESTIGATOR

• Tom Lumbers, MBBChir, PhD

  UCL

  STUDY CHAIR

• Anoop D Shah, MBBS, PhD

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility RCT with an alert intervention that is clinician facing

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 22, 2023
• Study Start: May 3, 2023
• Primary Completion: November 4, 2023
• Study Completion: December 4, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)