An interventional study of Dora in Cataract and After Cataract, sponsored by University of Plymouth. Completed at 2 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by University of Plymouth · Not applicable, Interventional, and Screening
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 225 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →University of Plymouth is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. The entire conversation will be supervised by a clinician. This clinician will be able to interrupt the call at any point if the system fails, the patient struggles to interact with it, or DORA does not collect sufficient information from the patient. The clinician will record a clinical assessment which will be compared to the DORA assessment.
Other: Dora
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.
Agreement
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
Time frame: Inter-rater reliability was assessed based on data collected during Dora calls, which lasted an average of 7.5 minutes
Clinical Complications Identified or Missed by DORA System
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
Time frame: Up to 90 days post surgery
Calls Completed Without Intervention
Number of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions
Time frame: Dora calls lasted an average of 7.5 minutes
System Usability
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Time frame: Usability assessments were completed up to 6 months after the Dora call
Usability of Telehealth System Implementation
Measured using the Telehealth Usability Questionnaire (minimum score of 1, maximum score of 5, averaged across 19 items; higher scores indicate better usability)
Time frame: Usability was assessed up to 6 months after the call
Qualitative Patient Perspectives of Usability
Qualitative feedback from semi-structured interviews
Time frame: 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
Qualitative feedback from semi-structured interviews
Time frame: 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
Qualitative feedback from semi-structured interviews
Time frame: 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
Qualitative feedback from semi-structured interviews
Time frame: Semi-structured interview call, lasting up to 30 minutes, conducted up to 6 months after the Dora call
Cost Impact
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).
Time frame: Conducted 6 months after baseline
Subsequent Unplanned Follow-up
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.
Time frame: Up to 90 days post surgery
| Milestone | Dora Follow-up Phone Call |
|---|---|
| Started | 225 |
| Completed | 202 |
| Not completed | 23 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 12 |
| Withdrew: Protocol violation | 9 |
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
| Participants | Dora Outcome Decision | Supervising Clinician Decision |
|---|---|---|
| Discharge | 117 | 131 |
| Review | 78 | 64 |
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
| Participants | Unexpected Management Change |
|---|---|
| Clinical Complications Identified or Missed by DORA System | 10 |
Number of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions
| DORA follow-up calls | Dora Follow-up Phone Call |
|---|---|
| Call completed autonomously | 195 |
| Call incomplete | 7 |
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
| units on a scale | Dora Follow-up Phone Call |
|---|---|
| System Usability | 77.76 ± 17.55 |
Measured using the Telehealth Usability Questionnaire (minimum score of 1, maximum score of 5, averaged across 19 items; higher scores indicate better usability)
| units on a scale | Dora Follow-up Phone Call |
|---|---|
| Usability of Telehealth System Implementation | 3.79 ± 0.89 |
Qualitative feedback from semi-structured interviews
| participants | Dora Follow-up Phone Call |
|---|---|
| Burden | 18 |
| Opportunity costs | 12 |
| Self-efficacy | 5 |
| Intervention coherence | 17 |
Qualitative feedback from semi-structured interviews
| participants | Dora Follow-up Phone Call |
|---|---|
| Affective attitude (anticipated) | 15 |
| Affective attitude (experienced) | 20 |
| Ethicality | 5 |
Qualitative feedback from semi-structured interviews
| participants | Dora Follow-up Phone Call |
|---|---|
| Willing | 15 |
| Not willing | 1 |
| Hesitant, but willing | 4 |
Qualitative feedback from semi-structured interviews
| participants | Dora Follow-up Phone Call |
|---|---|
| Perceived effectiveness (anticipated) | 4 |
| Perceived effectiveness (experienced) | 19 |
| Perceived effectiveness (long-term) | 19 |
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).
| Great British Pounds | Dora Follow-up Phone Call |
|---|---|
| Total staff cost (standard pathway) | 4555.16 |
| Total staff cost (Dora pathway) | 1084.21 |
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.
| Participants | Unplanned Follow-up |
|---|---|
| Subsequent Unplanned Follow-up | 5 |
Collected over Up to 3 months post cataract surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dora Follow-up Phone Call | 0/202 (0%) | 0/202 (0%) | 4/202 (2%) |
| Event | Dora Follow-up Phone Call |
|---|---|
| Symptomatic patients with unexpected management changesEye disorders | 4/202 |
| Age, Continuous(years) | Dora Follow-up Phone Call |
|---|---|
| Mean | 74 ± 8.96 |
| Sex: Female, Male(Participants) | Dora Follow-up Phone Call |
|---|---|
| Female | 116 |
| Male | 86 |
| Race/Ethnicity, Customized(Participants) | Dora Follow-up Phone Call |
|---|---|
| Ethnicity — White | 160 |
| Ethnicity — Asian | 12 |
| Ethnicity — Black | 11 |
| Ethnicity — Other | 17 |
| First or second cataract surgery(Participants) | Dora Follow-up Phone Call |
|---|---|
| First eye | 113 |
| Second eye | 89 |
| Income(Participants) | Dora Follow-up Phone Call |
|---|---|
| ≤ £19,999/yr | 28 |
| £20,000-29,999/yr | 24 |
| £30,000-39,999/yr | 5 |
| £40,000-49,999/yr | 5 |
| £50,000-69,999/yr | 9 |
| >£70,000/yr | 6 |
| Undefined | 70 |
| Education level(Participants) | Dora Follow-up Phone Call |
|---|---|
| Lower Than Bachelor's Degree | 88 |
| Bachelor's Degree or Higher | 43 |
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University of Plymouth