Involve-CAT
Research type
Research Study
Full title
Involve-CAT: A Feasibility Randomised Controlled Trial of a Cataract Decision Aid
IRAS ID
246649
Contact name
John Sparrow
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
Cataract is an extremely common potentially blinding age-related condition, with cataract surgery being the most frequently undertaken surgical procedure on the NHS (~450,000 in 2016-17). This study is part of a 5-year research Programme which aims to address issues of direct relevance to the perceptions of people with cataract undergoing surgery.
Overall, we aim to improve pre-operative decision making in cataract surgery, using evidence-based decision-support information on likely patient-reported benefits and individual risks of harm, whilst also investigating cost issues.
This current study is a feasibility study for using a Cataract Decision Aid (CDA) to support patient-clinician shared decision making. The CDA is a case-report form (CRF), however throughout this document, we will refer to this particular CRF as the CDA. We also aim to gather information to enable us to validate the benefits prediction model for self-reported benefits from cataract surgery (developed earlier in the Programme).
Patients who are eligible for cataract surgery will be randomly allocated to either continue with a routine assessment, or to use the CDA as part of their consultation with their clinician at their pre-operative stage. This study will assess the feasibility of a future full-scale trial.
We hypothesise that the use of the CDA will enhance patient-clinician shared decision making by incorporating patients' key concerns and general/personalised estimates of likely risks and benefits of cataract surgery and non-operative management. We expect patients' knowledge of the treatment options to improve, considering their own personal preferences during the deliberation process.
Summary of Results:
Decisions about whether to opt for cataract surgery right away, or to hold off, are mostly based on a patient’s ability to read a letter chart rather than on their real-world experience of their vision. This can mean that patients are sent for surgery before they really need it, or (more commonly) have to wait longer, until their vision is deemed poor enough. In order for the decision-making process to be more patient-friendly, we developed and tested a series of decision supporting ‘tools’ which give individual patients, and their doctors, a better understanding of how badly everyday vision is affected by their cataract(s).
To enable patients to express how their vision affects them day-to-day, we developed a short questionnaire, Cat-PROM5, which has been shown to work well. Cat-PROM5 can be completed by patients before they see their eye doctor and considered alongside the letter chart results. Cat-PROM5 can also be completed after surgery, which is useful for doctors to measure how much a patient has benefitted from surgery. Furthermore, our analysis allows the eye doctor to predict how good a patient’s vision is likely to be after the surgery, should they decide to go ahead.
People considering an operation usually also want to know what the risk is of things turning out badly. We have therefore developed a way to predict the risk of a complication occurring during the surgery and of loss of vision following the surgery, based on things like age and eye health.
Using these predictions, we created a cataract decision aid which also includes general cataract surgery information and frequently asked questions. This was tested and most of the patients and doctors thought it was useful, though it, and the way it is used, could still be improved.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0476
Date of REC Opinion
16 Aug 2018
REC opinion
Further Information Favourable Opinion