A Clinical Investigation of an Autonomous Phone Conversational Agent for Cataract Surgery Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Agreement
研究概览
简要总结
This project will apply AI technology to meet the gap between increasing demand and limited capacity of high- volume healthcare services. The project will develop evidence that will support the safe deployment of Ufonia's automated telemedicine platform to deliver calls to cataract surgery patients at two large NHS hospital trusts.
The proposed study will implement DORA in addition to the current standard of care for a cohort of patients at Imperial College Healthcare Trust and Oxford University Hospitals NHS Foundation Trust. The study will evaluate the agreement of DORA's decision with an expert clinician. In addition it will test the acceptability of the solution for patients and clinicians; the sensitivity and specificity of the system in deciding if a patient requires additional review; and the health economic benefits of the solution to patients (reduced time and travel) and the local healthcare system. If successful, a proposal will be developed to roll the solution out to all patients at each site in anticipation of an application to a late phase award for wider NHS deployment.
详细描述
Background
Due to an ageing population and increased expectation, the demand for many services is exceeding the capacity of the clinical workforce. As a result, staff are facing a crisis of burnout from being pressured to deliver high- volume workloads, driving increasing costs for providers. Artificial intelligence, in the form of conversational agents, presents a possible opportunity to enable efficiencies in the delivery of care.
Aims and Objectives
This study aims to evaluate the effectiveness, usability and acceptability of DORA - an AI-enabled autonomous telemedicine call - for detection of post-operative cataract surgery patients who require further assessment. The study's objectives are: to establish efficacy of DORA's decision making in comparison to an expert human clinician; baseline sensitivity and specificity for detection of true complications; evaluation of patient acceptability; evidence for cost-effectiveness; and to capture data that may support further studies.
Project plan and methods used
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
No masking is possible, because all participants receive the same intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent;
- •Aged 18 years or older;
- •On the waiting list for routine cataract surgery. Cataract surgery as part of a combined procedure with other ocular surgery will not be included;
- •No history or presence of significant ocular comorbidities that would be expected to alter the risks of cataract surgery or normal post-operative follow-up schedule. Note that significant ocular comorbidities do not include stable, chronic, or inactive ocular conditions such as amblyopia, drop-controlled stable glaucoma or ocular hypertension, previous squint surgery, inactive macular pathology, previous refractive surgery, or previous vitreoretinal surgery with stable retina.
排除标准
- •Individuals with any condition that could preclude the ability to comply with the study or follow-up procedures;
- •Presence of ocular or systemic uncontrolled disease (unless deemed not clinically significant by the Investigator and Sponsor);
- •Involved in current research related to this technology or been involved in related research to this technology prior to recruitment;
- •Cognitive difficulties, hearing impairment or non-English speakers;
- •History of current or severe, unstable or uncontrolled systemic disease (unless deemed not clinically significant by the Investigator and Sponsor).
结局指标
主要结局
Agreement
时间窗: Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes
Inter-rater reliability: the degree of agreement between DORA and the clinician on their assessments of the individual symptoms and the management plan; Whether or not the clinician had to interrupt the call to ask clarifying questions
次要结局
- Clinical Complications Identified or Missed by DORA System(Up to 90 days post surgery)
- Calls Completed Without Intervention(Dora calls lasted an average of 7.5 minutes)
- System Usability(Usability assessments were completed up to 6 months after the Dora call)
- Usability of Telehealth System Implementation(Usability was assessed up to 6 months after the call)
- Qualitative Patient Perspectives of Usability(Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call)
- Acceptability of AI Follow-up Phone Call(Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call)
- Satisfaction With AI Follow-up Phone Call(Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call)
- Appropriateness of AI for Follow-up Assessment(Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call)
- Cost Impact(Conducted 6 months after baseline)
- Subsequent Unplanned Follow-up(Up to 90 days post surgery)
研究者
Edward Meinert, PhD
Evaluation Lead
University of Plymouth