Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing. (ReVise)

February 9, 2025 updated by: Louise Allen, Cambridge University Hospitals NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients 4 years and older scheduled by their clinician for a follow up remote eye clinic consultation following an initial face-to face consultation.

Exclusion Criteria:

-Patients refusing remote consultation or converted to a face-to-face appointment following scheduling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: online questionnaires
Before and after online questionnaires
Staff participants
Medical and administrative eye clinic staff at participating centres. Normalisation process (NOMAD) online questionnaire before and after the implementation period.
Other: online questionnaires
Before and after online questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 months
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.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of East Anglia
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Louise Allen, Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2023

Primary Completion (Estimated)

September 3, 2025

Study Completion (Estimated)

February 2, 2026

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 9, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A096658

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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