Ophthalmic DisordersReViseNCT05941182
Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing.
An observational study of Ophthalmic Disorders, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This study aims to involve the public, patients and National Health Service (NHS) staff in co-designing a scalable, inclusive and sustainable implementation model for ophthalmic remote consultation with vision self-testing (the intervention). Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmic Disorders
- What is being tested?
- online questionnaires
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Sep 2023to 2 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients will reflect the diversity of the eye clinic population in terms of gender, age, social deprivation, ethnicity and sub-specialty eye condition.
Who may be able to join
- Patients 4 years and older scheduled by their clinician for a follow up remote eye clinic consultation following an initial face-to face consultation.
Who cannot join
- -Patients refusing remote consultation or converted to a face-to-face appointment following scheduling.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Cambridge University Hospital NHS Trust
Cambridge, Cambridgeshire, CB22 4XU
Louise Allen, 01223836819, louise@louiseallen.com
Mahmoud Hassan, mahmoud.hassan7@nhs.net
- Recruiting
Manchester University Hospitals NHS Trust
Manchester
Jane Ashworth, jane.ashworth@mft.nhs.uk
About this study
Official title: Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing. the ReVise Study.
This study aims to involve the public, patients and National Health Service (NHS) staff in co-designing a scalable, inclusive and sustainable implementation model for ophthalmic remote consultation with vision self-testing (the intervention). The main study questions are:
What are the barriers to uptake of the intervention and how can these be mitigated by the design of the implementation model.
How do implementation outcome measures compare before and after real world application of the model.
Read the detailed description
Background: Increasing demand for hospital eyecare and limited resources makes improved uptake of remote consultation essential. Unsupported workflows and the lack of an accurate visual acuity (VA) assessment are recognised factors limiting its uptake by ophthalmologists. Difficulties with accessing and trusting technology are widely reported barriers for patients. A novel implementation model of remote consultation with vision selftesting (using the DigiVis app in this study) which is co-designed with stakeholders could support and promote its use.
Methods: This mixed methodology, highly pragmatic study will take place in three large NHS eye departments (in Cambridge, Peterborough and Manchester) with high levels of age, ethnic, cultural and socio-economic diversity. Qualitative and quantitative data from semi-structured interviews, ethnographic field notes in the community and the Planning and Evaluating Remote Consultation Services (PERCS) framework in hospital-based patient and staff focus groups will identify implementation challenges. An implementation model to mitigate these challenges will be co-designed with stakeholders and put into operation. Patients will be allocated to the intervention pathway at their clinician's discretion and with their implied agreement in accepting the appointment.
Implementation and service outcomes will be assessed using the Practical, Robust, Implementation and Sustainability Model of the Reach Effectiveness Adoption Implementation Maintenance (PRISM RE-AIM) framework before, during and after 14 months of operation, enabling adaptation of the model.
Online questionnaires of approximately 100 patients assigned to the intervention by their clinician, will enable quantitative analysis of change in patients' perceived attributes of the e-health innovation scores before and after its use. Online questionnaires will enable quantitative changes in the Normalisation Process (NoMAD) scores of approximately 100 staff before and after implementation of the co-deisgned model to be analysed by descriptive statistics.
The optimised implementation model for the intervention, when scaled up, could reach over 3 million patients a year and alleviate some of the pressures on United Kingdom (UK) ophthalmology services. Dissemination of the model and toolkit via websites, publications and presentations to patients, clinicians, service managers and policy makers will supportthe adoption of remote consultations using self-assessment apps, like DigiVis. This could not only improve patient care in the NHS but improve access to eyecare and vision screening for rural communities internationally.
- Conditions
- Ophthalmic Disorders
- Being tested
- online questionnaires
- Keywords
- Remote consultation, visual acuity testing, self-testing applications, home-testing applications
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnairesOther
Before and after online questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patient participants | Participants who have been assigned to remote consultation follow up following a face-to-face appointment by their clinician.
Online Perceived Attributes of eHealth Technology online questionnaire before and after the remote consultation. Receives: Other: online questionnaires | |
| Staff participants | Medical and administrative eye clinic staff at participating centres. Normalisation process (NOMAD) online questionnaire before and after the implementation period. Receives: Other: online questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported perceived attributes of e-health innovation score
Change in the perceived attributes of e-health innovation score before and after experiencing remote consultation and self-testing of vision. This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after the remote consultation will be calculated for each patient and a mean change in score calculated. A higher magnitude positive change in score reflects an improved perception of the technology after the experience.
Measured: 30 months
Change in staff reported normalisation measure of the technology (NoMAD) score
Change in the NoMAD score before and after implementation of the remote consultation and self-testing of vision.This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after service implementation the remote consultation will be calculated for each member of staff and a mean change in score calculated. A higher magnitude positive change in score reflects improved normalisation and acceptance of the technology after implementation.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start3 Sep 2023
- Primary completion3 Sep 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, University of East Anglia, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Louise Allen, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Louise Allen, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941182
- Sponsor's protocol ID
- A096658
- Acronym
- ReVise
- Status last verified
- Feb 2025
- First submitted
- 26 Jun 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing. the ReVise Study.
- ClinicalTrials.gov ID
- NCT05941182
- Acronym / sponsor ID
- ReVise / A096658
- Conditions
- Ophthalmic Disorders
- Keywords
- Remote consultation, visual acuity testing, self-testing applications, home-testing applications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, University of East Anglia, National Institute for Health Research, United Kingdom
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to involve the public, patients and National Health Service (NHS) staff in co-designing a scalable, inclusive and sustainable implementation model for ophthalmic remote consultation with vision self-testing (the intervention). The main study questions are:
What are the barriers to uptake of the intervention and how can these be mitigated by the design of the implementation model.
How do implementation outcome measures compare before and after real world application of the model.
Detailed description
Background: Increasing demand for hospital eyecare and limited resources makes improved uptake of remote consultation essential. Unsupported workflows and the lack of an accurate visual acuity (VA) assessment are recognised factors limiting its uptake by ophthalmologists. Difficulties with accessing and trusting technology are widely reported barriers for patients. A novel implementation model of remote consultation with vision selftesting (using the DigiVis app in this study) which is co-designed with stakeholders could support and promote its use.
Methods: This mixed methodology, highly pragmatic study will take place in three large NHS eye departments (in Cambridge, Peterborough and Manchester) with high levels of age, ethnic, cultural and socio-economic diversity. Qualitative and quantitative data from semi-structured interviews, ethnographic field notes in the community and the Planning and Evaluating Remote Consultation Services (PERCS) framework in hospital-based patient and staff focus groups will identify implementation challenges. An implementation model to mitigate these challenges will be co-designed with stakeholders and put into operation. Patients will be allocated to the intervention pathway at their clinician's discretion and with their implied agreement in accepting the appointment.
Implementation and service outcomes will be assessed using the Practical, Robust, Implementation and Sustainability Model of the Reach Effectiveness Adoption Implementation Maintenance (PRISM RE-AIM) framework before, during and after 14 months of operation, enabling adaptation of the model.
Online questionnaires of approximately 100 patients assigned to the intervention by their clinician, will enable quantitative analysis of change in patients' perceived attributes of the e-health innovation scores before and after its use. Online questionnaires will enable quantitative changes in the Normalisation Process (NoMAD) scores of approximately 100 staff before and after implementation of the co-deisgned model to be analysed by descriptive statistics.
The optimised implementation model for the intervention, when scaled up, could reach over 3 million patients a year and alleviate some of the pressures on United Kingdom (UK) ophthalmology services. Dissemination of the model and toolkit via websites, publications and presentations to patients, clinicians, service managers and policy makers will supportthe adoption of remote consultations using self-assessment apps, like DigiVis. This could not only improve patient care in the NHS but improve access to eyecare and vision screening for rural communities internationally.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient participants | – | Other: online questionnairesParticipants who have been assigned to remote consultation follow up following a face-to-face appointment by their clinician. Online Perceived Attributes of eHealth Technology online questionnaire before and after the remote consultation. |
| Staff participants | – | Other: online questionnairesMedical and administrative eye clinic staff at participating centres. Normalisation process (NOMAD) online questionnaire before and after the implementation period. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients will reflect the diversity of the eye clinic population in terms of gender, age, social deprivation, ethnicity and sub-specialty eye condition.
Key inclusion criteria (1 listed)
- Patients 4 years and older scheduled by their clinician for a follow up remote eye clinic consultation following an initial face-to face consultation.
Key exclusion criteria (1 listed)
- -Patients refusing remote consultation or converted to a face-to-face appointment following scheduling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnairesBefore and after online questionnaires | Other | Patient participants, Staff participants |
Primary outcome
Change in patient reported perceived attributes of e-health innovation score
Time frame: 30 months
Change in the perceived attributes of e-health innovation score before and after experiencing remote consultation and self-testing of vision. This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after the remote consultation will be calculated for each patient and a mean change in score calculated. A higher magnitude positive change in score reflects an improved perception of the technology after the experience.
Change in staff reported normalisation measure of the technology (NoMAD) score
Time frame: 30 months
Change in the NoMAD score before and after implementation of the remote consultation and self-testing of vision.This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after service implementation the remote consultation will be calculated for each member of staff and a mean change in score calculated. A higher magnitude positive change in score reflects improved normalisation and acceptance of the technology after implementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise Allen principal investigator
Cambridge University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmic Disorders, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Allen (01223254665, Louise.allen47@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported perceived attributes of e-health innovation score (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.