跳至主要内容
临床试验/NCT05809232
NCT05809232尚未招募不适用

Impact of Machine Learning-based Clinician Decision Support Algorithms in Perioperative Care - A Randomized Control Trial (IMAGINATIVE Trial)

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 9,200 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
9,200
试验地点
1
主要终点
Change in perioperative mortality rates

研究概览

简要总结

Predicting surgical risks are important to patients and clinicians for shared decision making process and management plan. The study team aim to conduct a hybrid type 1 effectiveness implementation study design. A Randomized Controlled Trial where participants undergoing surgery In Singapore General Hospital (SGH) will be allocated in 1:1 ratio to CARES-guided (unblinded to risk level) or to unguided (blinded to risk level) groups. All participants undergoing elective surgeries in SGH will be considered eligible for enrolment into the study. For elective surgeries, the participants will mainly be recruited from Pre-admission Centre. The outcome of this study will help patients and clinicians make better decisions together. Firstly, the deployment of the CARES model in a live clinical environment could potentially reduce postoperative complications and improve the quality of surgical care provision. The findings from this study would allow fine-tuning of CARES as well as further deployment of additional risk models for specific complications other than Mortality and ICU stay. This in turn would translate to better health for the surgical population and improved cost-effectiveness. This is significant as the surgical population is expected to continuously grow due to improved access to care, better technologies and the aging population. Secondly, IMAGINATIVE will be instrumental in improving our understanding of the deployment strategies for AI/ML predictive models in healthcare. Models such as CARES could be the standard of care in the future if proven to improve the health outcomes of patients. As model deployments are costly and can be disruptive to the EMR processes, this study would be the initial spark for future deployment and health services research focusing on improving the value of these model deployments.

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
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients >=21 Years old
  • •Patients going for elective surgery
  • •For semi-structured interview:
  • •1. Any clinician or nurse that used CARES during the research trial

排除标准

  • •Patients with reduced mental capacity
  • •Patients who are unable to give consent

研究组 & 干预措施

CARES-guided Group

Active Comparator

The Intervention

干预措施: CARES-guided Group (Other)

Non CARES-Guided Group

No Intervention

The control - Participants randomized to the control arm will continue to have their routine Pre-Anesthesia Assessment on the electronic form, without the CARES calculator calculations, as per current practice

结局指标

主要结局

Change in perioperative mortality rates

时间窗: Five years

To assess the effectiveness of the Machine Learning Clinical Decision Support (ML-CDS). Hypothesis: The CARES-guided group will have a 30% relative reduction in one-year mortality rate due to the increased clinician awareness of the risks.

次要结局

  • Change in potentially avoidable planned ICU admission after surgery(Five years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验