Effect of Surgical Planning Prompts on Elective Surgery Acceptance Rate
ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji University
About this trial
This randomized, double-blind, controlled trial investigates whether prompting patients facing elective cataract surgery to articulate their specific conditions for choosing surgery (a structured self-reflection intervention commonly used in Shared Decision-Making) affects their subsequent decision to undergo the procedure. Eligible cataract patients who have been informed of surgical indications at an outpatient visit will be randomly assigned 1:1 to an intervention group (structured writing about personal conditions for accepting surgery) or a control group (no writing task). Both groups read the same standardized information about cataract diagnosis and treatment, and both complete the same set of follow-up questionnaire items. Three treating physicians independently rate their degree of surgical recommendation for each patient; these ratings along with baseline clinical measures are included as covariates in the analysis. The primary outcome is whether participants register for cataract surgery within 6 months of their initial outpatient consultation. Secondary outcomes include self-reported understanding of the condition, clarity of treatment plan, condition-related anxiety, perceived urgency, perceived helpfulness of the consultation, semantic analysis of written responses, and patient experience measures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Best Corrected Visual Acuity (BCVA) ≤ 0.5 and vision loss primarily attributable to cataract
Posterior subcapsular cataract with patient-reported significant impact from glare, halos, or impaired night driving
Patient-reported significant decrease in contrast sensitivity
Anisometropia or refractive error, and patient reports inability to accept spectacle correction impacting reading, daily chores, TV viewing, driving, or outdoor activities
Disqualifiers
Already decided to undergo or decline surgery at time of initial consultation
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Surgical Planning Self-Reflection
BehavioralParticipants are guided through an online structured writing exercise that prompts them to articulate the specific personal conditions under which they would choose to undergo elective cataract surgery. The prompt is embedded within an online questionnaire presented under the cover story of a comprehensive clinical assessment. It asks participants to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept the surgery, considering factors such as physical readiness, work, family, finances, timing, etc.
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: Structured Self-Reflection (Intervention)Experimental treatment 1 intervention
Group B: No Writing Task (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of Surgical Registration Within 6 Months
Proportion of participants who register (sign up) for cataract surgery at the Shanghai General Hospital Ophthalmology Clinical Center within 6 months of their initial outpatient consultation at which they were informed of surgical indications. Determined by cross-referencing surgery registration lists with study participant records.
Time frame
6 months from initial outpatient consultationSecondary outcomes
1
Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much)
Patient-reported level of understanding of their cataract condition following the outpatient consultation, measured via a single-item self-assessment in the online questionnaire.
Time frame
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)2
Clarity of Treatment Plan (3-point scale, 1 = not at all, 3 = very much)
Patient-reported sense of having a clear plan regarding subsequent treatment for their eye condition, measured via a single-item self-assessment.
Time frame
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)3
Condition-Related Anxiety (3-point scale, 1 = not at all, 3 = very much)
Patient-reported level of anxiety about their current cataract condition, measured via a single-item self-assessment.
Time frame
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)4
Perceived Urgency to Act (3-point scale, 1 = not at all, 3 = very much)
Patient-reported perceived urgency of taking the next step for their cataract condition, measured via a single-item self-assessment.
Time frame
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)Other outcomes
1
Physician Surgical Recommendation Rating (5-point scale, 1 = very weak, 3 = very strong)
Each of the three treating physicians independently rates their degree of recommendation for surgery for each patient they see, based on their clinical judgment of surgical appropriateness. These ratings serve as covariates to control for between-patient variation in clinical indication severity and between-physician variation in recommendation tendencies. Time Frame: At time of initial outpatient consultation
Time frame
within 24 hours of initial outpatient consultation2
Presenting Visual Acuity (Study Eye)
logMAR of the presenting visual acuity of the study eye measured using a standardized chart.
Time frame
Baseline (initial outpatient consultation)3
Best Corrected Visual Acuity (Study Eye)
logMAR of the best corrected visual acuity of the study eye following refraction.
Time frame
Baseline (initial outpatient consultation)4
Best Corrected Visual Acuity (Contralateral Eye)
logMAR of the corrected visual acuity of the non-study eye measured using a standardized chart.
Time frame
Baseline (initial outpatient consultation)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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