Clinical trial NCT05213390: Autonomous Telephone Follow-up After Cataract Surgery
Official title: A Clinical Investigation of an Autonomous Phone Conversational Agent for Cataract Surgery Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
After Cataract
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Imperial College London
First posted: 2022-01-28
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a multi-centre, mixed-methods clinical investigation to develop evidence regarding the feasibility, acceptability and potential effectiveness of Dora.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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

Based on implementation science, the interdisciplinary study will be a mixed-methods phase one pilot establishing inter-observer reliability; as well as usability and acceptability.

Timelines for delivery

The study will last eighteen months: seven months of evaluation and intervention refinement, nine months of implementation and follow-up, and two months of post-evaluation analysis and write-up.

Anticipated Impact and Dissemination

The project's key contributions will be evidence on artificial intelligence voice conversational agent effectiveness, and associated usability and acceptability. Results will be disseminated in peer-reviewed journals and at international medical sciences and engineering conferences.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Agreement
timeFrame: Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes
Secondary outcomes:
measure: Clinical Complications Identified or Missed by DORA System
timeFrame: Up to 90 days post surgery
measure: Calls Completed Without Intervention
timeFrame: Dora calls lasted an average of 7.5 minutes
measure: System Usability
timeFrame: Usability assessments were completed up to 6 months after the Dora call
measure: Usability of Telehealth System Implementation
timeFrame: Usability was assessed up to 6 months after the call
measure: Qualitative Patient Perspectives of Usability
timeFrame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
measure: Acceptability of AI Follow-up Phone Call
timeFrame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
measure: Satisfaction With AI Follow-up Phone Call
timeFrame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
measure: Appropriateness of AI for Follow-up Assessment
timeFrame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
measure: Cost Impact
timeFrame: Conducted 6 months after baseline
measure: Subsequent Unplanned Follow-up
timeFrame: Up to 90 days post surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Eduardo Normando, MD, PhD
role: STUDY_CHAIR
References:
citation: Milne-Ives M, de Cock C, Lim E, Shehadeh MH, de Pennington N, Mole G, Normando E, Meinert E. The Effectiveness of Artificial Intelligence Conversational Agents in Health Care: Systematic Review. J Med Internet Res. 2020 Oct 22;22(10):e20346. doi: 10.2196/20346.
citation: de Pennington N, Mole G, Lim E, Milne-Ives M, Normando E, Xue K, Meinert E. Safety and Acceptability of a Natural Language Artificial Intelligence Assistant to Deliver Clinical Follow-up to Cataract Surgery Patients: Proposal. JMIR Res Protoc. 2021 Jul 28;10(7):e27227. doi: 10.2196/27227.