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A feasibility study of the use of a cataract surgery decision aid which includes personalised estimates of risks and benefits

Involve-CAT: a feasibility randomised controlled trial of a cataract decision aid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11309852
Enrollment
40
Registered
2019-05-16
Start date
2018-10-09
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shared decision-making about cataract surgery Eye Diseases

Interventions

Participants enrolled into the study will be invited for a research appointment alongside their Cataract Assessment appointment. A member of the research team will accompany participants throughout

Sponsors

University Hospitals Bristol NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients: Patients undergoing cataract surgery are eligible to be recruited to the study if they meet the following criteria: 1. Aged 50 years or over at time of recruitment 2. Referred for and subsequently deemed clinically eligible for either first or second eye cataract surgery 3. Ability to provide informed consent 4. Ability to read and understand study materials (PIS, Cat-PROM5, CDA, CDQM etc) 5. Willingness to participate Health Professionals: Health Professionals are eligible to be recruited to the study if they meet the following criteria: 1. Willingness to participate 2. Ability and willingness to use the Cataract Decision Aid to help patients make a decision about whether or not to have cataract surgery

Exclusion criteria

Exclusion criteria: Previous participation in earlier elements of the cataract research programme

Design outcomes

Primary

MeasureTime frame
Patients’ knowledge about options, their preferences and readiness to make a decision, assessed using the Cataract Decision Quality Measure before and after pre-operative clinician consultation

Secondary

MeasureTime frame
The likely effectiveness and cost-effectiveness of the decision support tool and the need for a subsequent full-scale trial, assessed through analysis of the following themes: 1. Estimated sample size, and the most appropriate primary/secondary outcomes for a main trial assessed using the effect size 2. Recruitment and retention rates, comparing numbers of study completion, declines and screen failures against routine care volume over the recruitment period 3. Decision support costs estimated through analysis of the duration and staff costs of pre-operative assessment and data collection in the intervention arm compared to routine care arm 4. Potential cost savings from avoidance of high risk/low benefit surgery and avoiding costly complications and complication-induced visual disability 5. Quality and level of shared decision making assessed using the Observer OPTION5 instrument during pre-operative assessment 6. Patient and clinician experience of the use of decision support tools, assessed using qualitative interviews after the pre-operative assessment study visit 7. Acceptability of the decision aid to patients and clinicians, assessed using qualitative interviews after the pre-operative assessment study visit 8. Self-reported difficulty with vision, assessed using the Cat-PROM5 questionnaire pre- and post-operatively 9. Uptake of cataract surgical option following patient-clinician interaction when using CDA compared to routine care 10. Initial validation of the benefits prediction model developed earlier in the Programme for predicting self-reported Cat-PROM5 benefit from surgery, assessed pre and post-operatively

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026