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Completed

NCT Number: NCT05213390

Autonomous Telephone Follow-up After Cataract Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dora

Other

DORA uses a variety of AI technologies to deliver the patient follow-up call, including: speech transcription, natural language understanding, a machine-learning conversation model to enable contextual conversations, and speech generation. Together, these technologies cover the input, processing and analysis, and output needed to maintain a natural conversation. DORA is configured to deliver calls through a telephone connection as a real-time, stand-alone system: the operator inputs individual patient details to initiate the call and completes a summary in the electronic health record (EHR) afterwards.

Primary outcomes

  1. Agreement

    Time frame: 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

Secondary outcomes

  1. Clinical Complications Identified or Missed by DORA System

    Time frame: Up to 90 days post surgery

    Clinical data was collected from patients' electronic health record (EHR) up to 90 days postoperatively to capture numbers of participants 'recommended discharge' by Dora R1 with subsequent unexpected management change

  2. Calls Completed Without Intervention

    Time frame: Dora calls lasted an average of 7.5 minutes

    Number of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions

  3. System Usability

    Time frame: Usability assessments were completed up to 6 months after the Dora call

    Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)

  4. Usability of Telehealth System Implementation

    Time frame: Usability was assessed up to 6 months after the call

    Measured using the Telehealth Usability Questionnaire (minimum score of 1, maximum score of 5, averaged across 19 items; higher scores indicate better usability)

  5. Qualitative Patient Perspectives of Usability

    Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

    Qualitative feedback from semi-structured interviews

  6. Acceptability of AI Follow-up Phone Call

    Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

    Qualitative feedback from semi-structured interviews

  7. Satisfaction With AI Follow-up Phone Call

    Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

    Qualitative feedback from semi-structured interviews

  8. Appropriateness of AI for Follow-up Assessment

    Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call

    Qualitative feedback from semi-structured interviews

  9. Cost Impact

    Time frame: Conducted 6 months after baseline

    A cost analysis compared the direct costs of face-to-face (F2F) follow-up at Imperial with Dora R1 (in Oxford, patients do not have routine postoperative follow-up). Assumptions included annual costs for various healthcare professionals and the duration of F2F follow-up appointments (estimated at 30 min).

  10. Subsequent Unplanned Follow-up

    Time frame: Up to 90 days post surgery

    Clinical data was collected from patients' electronic health record (EHR) up to 90 days postoperatively to capture numbers of participants 'recommended discharge' by Dora R1 with subsequent unplanned review.

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Collaborators

  • Imperial College London
  • University of Oxford

Registry information

Official study title

A Clinical Investigation of an Autonomous Phone Conversational Agent for Cataract Surgery Follow-up

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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