The TRIAGE Study: Identifying Non-Responders to Glaucoma Eye Drops

Plain English summary of protocol

Background and study aims
Patients with glaucoma have high pressure in their eyes (intraocular pressure, IOP) for which initial treatment is the administration of eye drops on a daily basis to reduce the pressure. If untreated, this high pressure can lead to blindness. When a patient with glaucoma returns to clinic and continues to have high pressure, it is unknown whether this is because of the way their eye works or because they are not using the eye drops properly. In the NHS at present, it can take many months to distinguish between those who respond to eye drops and those who do not. This is wasteful of time and medicines, as well as increasing the risk that patients develop adverse drug reactions when alternative drugs are tried, rather than addressing the true problem of adherence. We propose a new way of working (the Cardiff Model of Glaucoma Care, CMGC) which will mean, at most, two extra clinic visits (soon after being prescribed eye drops and four weeks later). At four weeks, patients will know whether their treatment works for them. After which, patients will return to their original clinic where those who do not respond to treatment will have the opportunity to discuss alternate treatment. The ultimate goal of this research is to reduce the time taken to identify whether patients respond to eye drops from a current uncertain, lengthy period of months to within four weeks, and thereby personalise eye medication to individuals with glaucoma more efficiently than is currently practiced in the NHS. The aim of this stage of the research is to develop and test the appropriateness of a new way of identifying people for whom eye drops do not work.

The research questions the study looks to address are as follows:
RQ1. Problem identification: What is the usual care for patients diagnosed with glaucoma who are about to commence eye drop treatment in Wales, in terms of identifying patients’ responses to treatment?
RQ2. Development of intervention; Assessment of barriers to implementation; and Implementation and adaptation to context: Is it possible to develop and implement the Cardiff Model of Glaucoma Care (CMGC) into routine clinical practice?
RQ3. Monitoring and evaluation of implementation process and outcomes: What is the feasibility and NHS costs of implementing the CMGC?
RQ4. Monitoring and evaluation of implementation process and outcomes: Is the CMGC acceptable to patients and healthcare professionals?
RQ5. Monitoring and evaluation of implementation process and outcomes: How might CMGC become embedded in practice? Synthesis of mixed method study findings from phases RQ1 to RQ4.

Who can participate?
RQ1: CLINICAL OBSERVATIONS, SITUATED INTERVIEWS AND SURVEY
Clinical observations and situated interviews: Healthcare professionals providing care in glaucoma clinics, alongside glaucoma patients receiving such care.
Survey: Glaucoma specialist leads (or nominated individuals) in each of the Welsh health boards: Abertawe Bro Morgannwg, Aneurin Bevan, Powys, Hywel Dda and Betsi Cadwaladr
RQ2: SOP DEVELOPMENT AND FOCUS GROUPS ON SOP
SOP development: A mixed group of key stakeholders including nurses, doctors, optometrists, orthoptists, pharmacists and patients. These members will be identified in liaison with the health boards involved with the study, as well as the International Glaucoma Association, so as to include the most appropriate parties.
Focus groups and interviews: A mixed group of key stakeholders including patients, carers, doctors, pharmacists, optometrists, orthoptists, nurses, policy makers and managers. These members will be identified in liaison with the two health boards involved with the study, as well as the International Glaucoma Association, so as to include the most appropriate parties.
RQ3: COHORT FEASIBILITY STUDY
CMGC cohort feasibility study: Glaucoma or ocular hypertension patients on the point of being prescribed eye drops will be recruited to the feasibility study across the primary research sites of Cwm Taf and Cardiff and Vale University health boards, as well as any other health boards later integrated into this phase of the study e.g. Abertawe Bro Morgannwg University health board.
CMGC staff training: Staff members for the CMGC will be comprised of doctors, nurses, optometrists or orthoptists working within either Cardiff and Vale University health board or Cwm Taf University health board, or any other health board later integrated into this phase of the study e.g. Abertawe Bro Morgannwg University health board.
RQ4: PATIENT / HEALTHCARE PROFESSIONAL INTERVIEWS AND OBSERVATION
Patient interviews: Interviews will be held with patients based within three sampling cohorts. The sampling cohorts are patients who have either i) never participated in CMGC and whom are eye drop naïve, or ii) never participated in CMGC and who are established eye drop users, or iii) participated in CMGC and are up to 4 months post-CMGC.
Healthcare professional interviews: Healthcare professionals and management team involved in the study across each of the respective health boards.
Observations: Participants for this element of the research would be those patients and healthcare professionals who provided consent to be involved for the cohort feasibility study.
RQ5. SYNTHESIS OF FINDINGS
No participants required.

What does the study involve?
RQ1: CLINICAL OBSERVATIONS, SITUATED INTERVIEWS AND SURVEY
Clinical observations and interviews: Observations will be carried out on between 30 and 50 clinical consultations across both research sites. This will involve recruiting between 30 and 50 glaucoma patients and between eight and 15 healthcare professionals for both the observation and the situated interviews.
Survey: The survey on current glaucoma practice will be issued out to all glaucoma leads based in the Welsh health boards, aside from those based in the primary research sites of Cardiff and Vale University Health Board and Cwm Taf University Health Board. This is expected to be between 5 and 12 specialists.
RQ2: SOP DEVELOPMENT AND FOCUS GROUPS ON SOP
SOP Development: The group of stakeholders for the SOP development meetings is expected to number between 10 and 12 participants in total.
Focus groups and Interviews: Four focus groups will be held, each comprising up to six to eight stakeholder members, including glaucoma patients and healthcare professionals. Based on participant availability, one-to-one and one-to-two interviews may also be conducted. This will result in a sample of between 24 and 32 participants.
RQ3: COHORT FEASIBILITY STUDY
CMGC cohort feasibility study: 60 glaucoma patients will be recruited to the feasibility study across each of the research sites. Should recruitment prove an issue to either of the first two primary research sites (Cardiff and Vale and Cwm Taf), this can be expanded to other Welsh health boards
CMGC staff training: Between four and seven healthcare professionals in each of the research sites (eight to 14 in total) will be expected to be working with the CMGC and be required to undertake training in relation to best practice from the developed SOP.
RQ4: PATIENT / HEALTHCARE PROFESSIONAL INTERVIEWS AND OBSERVATION
Patient interviews: Across the sampling cohorts, it is anticipated that between 18 and 30 glaucoma patients of varying backgrounds will be recruited to be interviewed. 6 to 10 of these will have been retained in the study following phase RQ3.
Healthcare professional interviews: It is expected that between 6 and 10 participants comprising nurses, consultants and clinic managers working within the CMGC will be recruited for these healthcare professional interviews.
Observations: It is expected that between 30 and 45 hours of observation will be carried out across all applicable research sites. This will involve between 6 and 10 healthcare professionals and between 30 and 45 glaucoma patients.

What are the possible benefits and risks of participating?
The study is unlikely to harm patients in any way as it does not involve any additional administration of medicines or treatments to those that would already be received. Indeed, the intention of the CMGC is to identify non-respondent patients and ensure they receive the appropriate care more quickly than in current practice. That said, there is the risk that patients may experience a time burden through attending the CMGC with the number of clinical attendances initially front-loaded. However, the study aims to identify any such issues as perceived by the patient, with the hope being that identifying the appropriate treatment early on outweighs any potential burdens and ultimately saves patients’ time.
For NHS staff participants involved with the CMGC there will be a requirement to attend training sessions on its delivery. However, the benefits for glaucoma clinic staff in terms of gaining competence and confidence in the CMGC is felt to outweigh any of these burdens.

Where is the study run from?
The research is part of a project based at Cardiff University in the School of Healthcare Sciences and the School of Optometry and Vision Sciences. The project is led by Professor James Morgan and Professor Heather Waterman.

When is the study starting and how long is it expected to run for?
December 2017 to March 2019

Who is funding the study?
Health and Care Research Wales

Who is the main contact?
Dr. Simon Read, readsm@cardiff.ac.uk

Contact information

Dr Simon Read
Public

School of Healthcare Sciences
Cardiff University
Eastgate House
35-43 Newport Road
Cardiff
CF24 0AB
Cardiff
CF24 0AB
United Kingdom

ORCID ID	0000-0003-2445-283X
Phone	02920 688930
Email	readsm@cardiff.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• Wales

Study participating centres

Sponsor information

Cardiff University
University/education

7th Floor, McKenzie House
30-36 Newport Road
Cardiff
Cardiff
CF24 0DE
Wales
United Kingdom

Phone	02920879277
Email	resgov@cardiff.ac.uk
Website	http://www.cardiff.ac.uk/
"ROR"	https://ror.org/03kk7td41

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

26/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
05/04/2019: Internal review.
04/04/2019: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/07/2019 to 31/07/2020
2. The recruitment end date was changed from 31/03/2019 to 15/04/2019
08/03/2019: Internal review.
04/03/2019: Trial’s existence confirmed by IRB.