Clinical trial NCT05941182: Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing.
Official title: Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing. the ReVise Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ophthalmic Disorders
Keywords: Remote consultation
visual acuity testing
self-testing applications
home-testing applications
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
name: University of East Anglia
name: National Institute for Health Research, United Kingdom
First posted: 2023-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in patient reported perceived attributes of e-health innovation score
timeFrame: 30 months
measure: Change in staff reported normalisation measure of the technology (NoMAD) score
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Trust
state: Cambridgeshire
city: Manchester
country: United Kingdom
facility: Manchester University Hospitals NHS Trust
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Louise Allen
role: PRINCIPAL_INVESTIGATOR
References: