A Single-Centre Feasibility Study of PROSPECTOR - Point of Care RandOmisation Systems for Performing Embedded Comparative Effectiveness Trials Of Routine Treatments in Critical Care
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effectiveness of Electronic Point of Care Randomisation Prompts
研究概览
简要总结
Every day, doctors and nurses make hundreds of decisions about treatments - like when to start or stop them, or how frequently to give them. Ideally, decisions are based on gold standard evidence from Randomised Controlled Trials (RCTs). Unfortunately, for many treatments little or no evidence exists and clinicians must use knowledge and experience to decide what is best.
As clinicians are all different, this leads to random variation in how treatments are given to patients. For example, magnesium is routinely given in intensive care to prevent abnormal heart rhythms. There is little evidence supporting this, and clinicians vary in how they administer magnesium. Traditional RCTs might be used to examine whether more magnesium is better than less magnesium, but this method is inefficient and expensive for investigating multiple comparative treatment questions.
Clinical trials are becoming more efficient by using existing hospital computer systems to run them. However, research teams continue to perform tasks like randomisation manually. For questions like magnesium supplementation, which occur daily, this is labour intensive and infeasible.
Hospital computer systems also possess mechanisms for prompting and alerting clinicians for particular decisions, reminding them of best practices, warning them of potential problems. These systems may be modified to allow clinicians to randomise patients, under specific conditions.
The investigators propose to assess whether modified computer prompts can be used to highlight the magnesium supplementation decision to clinicians. These would prompt the clinician to evaluate the uncertainty around giving or withholding magnesium in that instance. If in agreement that the optimal decision is unclear, clinicians can choose to randomise the patient within a predetermined trial structure. If the clinician knows better, they may override the prompt and continue with their preference. In both cases, the system learns from the decision and the patient receives optimal care determined by their clinician.
详细描述
Trial Design:
A single-centre, mixed methods, feasibility study, embedded within the Electronic Health Record System (EHRS). The study will be conducted on critical care units within University College London Hospitals NHS Trust and will involve patients undergoing elective major surgery which necessitates postoperative admission to critical care. The study will be pragmatic in nature, with minimal disruption to usual care pathways.
The study will consist of three phases:
- Feasibility Phase - Simulation guided semi-structured interviews with clinicians.
- Intervention Phase - Deployment of electronic prompts to evaluate candidate clinical question.
- Follow Up Phase - Patient and clinician semi-structured interviews.
Research Hypothesis:
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
- •Age 18 years or over.
- •Undergoing elective surgery of complexity sufficient to warrant postoperative critical care admission (major/complex major surgery)
- •Must be able to give written informed consent to participate
- •Clinicians:
- •Must be regularly involved in the care of postoperative patients in critical care.
排除标准
- •Active treatment for bronchospasm preceding deployment of the electronic prompt, defined as patient receiving bronchodilator therapy or Magnesium infusion.
- •Any documented allergy or intolerance to any preparation of supplemental Magnesium.
- •Serum Magnesium result > 1.5 or < 0.5 mmol/L on blood tests obtained during critical care admission .
- •Atrial Fibrillation on initial arrival to critical care.
研究组 & 干预措施
Nudge Prompt, Liberal Magnesium Strategy
This group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
干预措施: Electronic Point of Care Randomisation tool (Other)
Nudge Prompt, Liberal Magnesium Strategy
This group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
干预措施: Magnesium (Drug)
Nudge Prompt, Restrictive Magnesium Strategy
This group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
干预措施: Electronic Point of Care Randomisation tool (Other)
Nudge Prompt, Restrictive Magnesium Strategy
This group will be randomised to receive the Nudge design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
干预措施: Magnesium (Drug)
Preference Prompt, Liberal Magnesium Strategy
This group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
干预措施: Electronic Point of Care Randomisation tool (Other)
Preference Prompt, Liberal Magnesium Strategy
This group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a liberal magnesium supplementation strategy.
干预措施: Magnesium (Drug)
Preference Prompt, Restrictive Magnesium Strategy
This group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
干预措施: Electronic Point of Care Randomisation tool (Other)
Preference Prompt, Restrictive Magnesium Strategy
This group will be randomised to receive the Preference design of electronic point of care randomisation prompt. The prompt will encourage the clinician to follow a restrictive magnesium supplementation strategy.
干预措施: Magnesium (Drug)
结局指标
主要结局
Effectiveness of Electronic Point of Care Randomisation Prompts
时间窗: Duration of individual participant admission to critical care, or five postoperative days, whichever is sooner
The proportion of each design which result in compliance with the randomised allocation by the clinician. We define compliance with the prompt as 1) the appropriate administration of supplemental magnesium, following receiving the electronic prompt, where the measured serum magnesium is less than the randomised threshold OR; 2) the appropriate withholding of supplemental magnesium following prompt deployment, where the measured serum magnesium is greater than the randomised threshold.
次要结局
- Acceptability to patients of using either a Pre-Emptive or Opt-Out model to obtain informed consent for the conduct of Comparative Effectiveness Research, assessed by semi-structured interview.(Throughout study duration, maximum 6 months from study start date)
- Acceptability to critical care clinicians of using the Electronic Point of Care Randomisation prompts assessed by semi-structured interviews(Throughout study duration, maximum 6 months from study start date)
- Clinician preferences for type of Electronic Point of Care Randomisation Prompt design assessed by semi-structured interviews(Throughout study duration, maximum 6 months from study start date)