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Autonomous Telephone Follow-up After Cataract Surgery

Primary Purpose

Cataract, After Cataract

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dora
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cataract

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Imperial College Healthcare NHS Trust
  • Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dora follow-up phone call

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical complications identified or missed by DORA system
Complications identified from patients' electronic health records up to 90 days following cataract surgery; Congruence between complications identified and management planned in DORA call and face-to-face follow up (Imperial); Comparison to data from patients attending eye casualty (Oxford)
Proportion of calls completed without intervention
Proportion of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions
System usability
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
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)
Qualitative patient perspectives of usability
Qualitative feedback from semi-structured interviews
Acceptability of AI follow-up phone call
Qualitative feedback from semi-structured interviews
Satisfaction with AI follow-up phone call
Qualitative feedback from semi-structured interviews
Appropriateness of AI for follow-up assessment
Qualitative feedback from semi-structured interviews
Cost impact
Comparison of the costs of implementing DORA and the costs of the usual standard of care

Full Information

First Posted
November 8, 2021
Last Updated
September 1, 2022
Sponsor
University of Plymouth
Collaborators
University of Oxford, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT05213390
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
Collaborators
University of Oxford, Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, After Cataract

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
No masking is possible, because all participants receive the same intervention.
Allocation
N/A
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dora follow-up phone call
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dora
Intervention Description
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 Outcome Measure Information:
Title
Agreement
Description
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
6 months
Secondary Outcome Measure Information:
Title
Clinical complications identified or missed by DORA system
Description
Complications identified from patients' electronic health records up to 90 days following cataract surgery; Congruence between complications identified and management planned in DORA call and face-to-face follow up (Imperial); Comparison to data from patients attending eye casualty (Oxford)
Time Frame
Up to 90 days post surgery
Title
Proportion of calls completed without intervention
Description
Proportion of autonomous calls that were completed without needing any intervention from the supervising clinician; Clinician-reported reasons for asking clarifying questions
Time Frame
6 months
Title
System usability
Description
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Time Frame
6 months
Title
Usability of telehealth system implementation
Description
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
6 months
Title
Qualitative patient perspectives of usability
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Acceptability of AI follow-up phone call
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Satisfaction with AI follow-up phone call
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Appropriateness of AI for follow-up assessment
Description
Qualitative feedback from semi-structured interviews
Time Frame
6 months
Title
Cost impact
Description
Comparison of the costs of implementing DORA and the costs of the usual standard of care
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Normando, MD, PhD
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33090118
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.
Results Reference
background
PubMed Identifier
34319248
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.
Results Reference
background

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Autonomous Telephone Follow-up After Cataract Surgery

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