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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Difference in oral fluid intake between intervention and control arms
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •On a surgical, obstetric or critical care ward environment
- •Patients who opt out of study
结局指标
主要结局
Difference in oral fluid intake between intervention and control arms
时间窗: 48 hours after randomisation
Difference in documented oral intake (ml)
Number of patients recruited into the trial
时间窗: 3 months
The number of patients in which the usual care team thought there was equipoise for oral fluid restriction
次要结局
- 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)
- Length of stay(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(From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date)
- Prescription of Diuretic medications(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)
- Daily change in creatinine(From 48 hours after randomisation until date of hospital discharge, assessed up to 120 days after trial start date)
- Patient reported outcome measure(From date of randomisation until date of hospital discharge, assessed up to 120 days after trial start date)