跳至主要内容
临床试验/NCT05355727
NCT05355727Unknown不适用

PROSAIC-DS (PROState AI in Cancer - Decision Support): Evaluation of the Deontics AI Platform for Evidence-based Treatment Planning in Multidisciplinary Cancer Care: Increasing Compliance and Streamlining MDTs in Prostate Cancer

Guy's and St Thomas' NHS Foundation Trust4 个研究点 分布在 1 个国家目标入组 1,040 人开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,040
试验地点
4
主要终点
PROSAIC-DS as a triage tool

研究概览

简要总结

Around 375,000 cancers are diagnosed in the UK annually, with this figure expected to reach 500,000 by 2035. As the number of different cancer treatment options and our scientific understanding continue to grow rapidly, it can be difficult for clinicians to keep up-to-date with best practice, causing unjustified variations in the quality of care and clinical outcomes for patients.

Currently, when a patient has been referred to and seen by a clinician, their treatment is then discussed in a Multi-Disciplinary Team Meeting (MDTM). MDTM is a meeting of medical experts, including Surgeons, Oncologists, Nurses, and specialists in cancer, imaging and diagnosis. This is the case even if a treatment decision is straightforward.

A nationwide review published by CRUK in 2017 highlighted the demands on cancer teams and the MDTM process:

  • Increased caseloads are causing dramatic increases in the time spent by clinicians in MDTMs, leading to an unsustainable rise in costs: the cost in England has increased from £88m to £159m in 4 years;
  • There is not enough time in the MDTM to discuss complex cases;
  • There is a failure to involve patients in the decision-making process: around 75% of patients feel their views are unrepresented in MDTMs; In our study we are looking at the potential of technology - particularly Clinical Decision Support Systems (CDSS) - to improve MDTM decision making.

Deontics has a CE marked AI-based CDSS that integrates individual patient data and preferences with evidence-based clinical guidelines. This dynamically and transparently generates best-practice, individualised treatment recommendations which can help determine treatment. Deontics' AI tool has already been shown to provide personalised recommendations concordant with UK best practice while incorporating patient values, and can be used to safely triage less complex patients straight to treatment with minimal clinical oversight. Our project partners with Deontics to develop PROSAIC-DS - A CDSS for prostate cancer.

详细描述

I

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients referred to the GSTT and KCH Prostate MDT meetings where sufficient information is available for the MDT to make a treatment decision (approximately 40-50 per week) will be eligible for the study.

排除标准

  • If data available for patients is not adequate to make any treatment decisions they will be excluded. Non-consenting patients will be excluded.

结局指标

主要结局

PROSAIC-DS as a triage tool

时间窗: 6-9 months

The % of patients the PROSAIC-DS tool can appropriately triage away non-complex Prostate Cancer cases from the MDTM with appropriate treatment plans as directed by approved guidelines (EAU, BAUS, NICE, AUA).

PROSAIC-DS influence on MDTM concordance with approved guidelines

时间窗: 6-9 months

Evaluation of PROSAIC-DS as a member of the MDTM via the impact of live PROSAIC-DS recommendations on MDTM decision concordance with approved guidelines (EAU, BAUS, NICE, AUA) on randomised patients discussed in the MDTM. This is measured through the difference in level of concordance between the MDTM with PROSAIC-DS switched off and the MDTM with PROSAIC-DS on when less complex cases (ones triaged away) are excluded.

次要结局

  • Cost effectiveness of PROSAIC-DS(6-9 months - duration of data collection)
  • Qualitative Analysis: Patient acceptability(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验