THIRST Alert Trial (THIRST)

THIRST Alert Trial - a 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

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.

Study Overview

• Status: Recruiting
• Conditions: Fluid Overload; Congestive Heart Failure
• Intervention / Treatment: Behavioral: Fluid restriction; Behavioral: Free fluids

Detailed Description

Trial Design:

A single centre, pragmatic, parallel group randomised controlled trial and feasibility study. The study will be conducted entirely within University College Hospital, at University College London Hospitals NHS Foundation Trust.

Research Hypothesis:

Clinician-facing alerts, delivered through the electronic health records system, provide a feasible method of enrolling patients into pragmatic trials evaluating the effectiveness of routine treatments

Clinical Research question:

In hospitalised patients with fluid overload, does an automated clinician-facing computerised decision support system (CDSS) alert recommendation for either oral fluid restriction (to 1L per day) or no-fluid restriction (continue with free fluids) result in a change in clinical behaviour and change in the oral fluid intake of enrolled patients?

Study participants:

The study population will be patients treated for suspected fluid overload with a regular prescription of intravenous (IV) furosemide within 48 hours of an unplanned hospital admission.

For staff participants, any clinician with prescribing rights for IV furosemide may be exposed to the CDSS alert. For subsequent medical staff, nursing staff and other allied health professionals, patient enrolment into the trial and their treatment allocation status will be communicated through both EHR and clinical processes that are embedded within routine care, including verbal and non-digital patient handover.

Summary of Interventions:

This study will evaluate the effect of a Best practice advisory (BPA) interruptive alert that is embedded within the electronic health record (EHR) used at the study site. The first BPA will ask the treating clinician whether they judge randomisation to either oral fluid restriction or no restriction is appropriate - if yes is selected, randomised allocation to one of two subsequent alerts will occur at the point of care. This intervention will be tested in silico prior to deployment to the live EHR.

Ethics:

This study protocol was approved by the London Riverside Research Ethics Committee (Ref: 22/LO/0889) and sponsored by University College London (Ref: 151938).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Chen, BMBCh, MSc; Phone Number: 020 3447 8066; Email: yang.a.chen@ucl.ac.uk
• Study Contact Backup: Name: Tom Lumbers, MBBChir, PhD; Phone Number: 020 3447 8066; Email: t.lumbers@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Recruiting
    • University College Hospital
    • Contact: Yang Chen, BMBCh; Email: yang.a.chen@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Prescribed IV furosemide during the first 48h of their admission as a regular prescription rather than a one-off dose.
• Assessed as being suitable for inclusion in the trial by the responsible clinical team i.e., fluid restriction deemed to be in equipoise.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alert recommending oral fluid restriction; The alert will suggest to the treating clinician to fluid restrict the patient to 1L of oral fluid per day	Behavioral: Fluid restriction; Oral fluid restriction of 1000ml per day
Active Comparator: Alert recommending no oral fluid restriction; The alert will suggest to the treating clinician to continue without any oral fluid restriction	Behavioral: Free fluids; Continue care without any oral fluid restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to randomised alert recommendation	Proportion of alerts actioned with corresponding clinical documentation	During trial recruitment window (up to day 2)
Proportion of alerts with clinical orders for nursing staff	Corresponding documentation of nursing receipt of treatment allocation	During trial recruitment window (up to day 2)
Oral fluid intake	Documented oral fluid intake (ml)	From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date
Net fluid balance	Documented overall fluid balance (ml)	From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date
Weight change after randomisation	Weight (kg)	48 hours after randomisation
Length of stay	Number of Days	From day of admission to day of discharge, assessed up to 120 days after trial start date
Frequency of blood test measurements of renal function	Number of times blood tests are measured	From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date
Prescription of Diuretic medications	Dose and duration of intravenous and oral diuretics	From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date
Daily change in creatinine	48 hours after randomisation	From 48 hours after randomisation until date of hospital discharge, assessed up to 120 days after trial start date
Patient reported outcome measure	Visual analog scale (1-10) of wellbeing, thirst perception and breathlessness	From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals (UCLH) NHS Foundation Trust; National Institute for Health and Care Research (NIHR) UCLH Biomedical Research Centre
• Investigators: Principal Investigator: Yang Chen, BMBCh, MSc, UCL; Study Chair: Tom Lumbers, MBBChir, PhD, UCL; Principal Investigator: Anoop D Shah, MBBS, PhD, UCL

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): November 4, 2023
• Study Completion (Estimated): December 4, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Electronic health record; Pragmatic trial; Comparative effectiveness research; Learning health systems; Treatable trait
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 151938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No