Effect of Surgical Planning Prompts on Elective Surgery Acceptance Rate

NCT07544641 | Not Yet Recruiting

• 1 other identifier: elective surgery cataract
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cataract

Keywords

Cataract; Shared Decision-Making; Elective Surgery; Surgical Planning; Decision Aid; Patient Autonomy; Behavioral Intervention

Outcome Measures

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.

  6 months from initial outpatient consultation

Secondary Outcomes (6)

• Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much)

  At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

• Clarity of Treatment Plan (3-point scale, 1 = not at all, 3 = very much)

  At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

• Condition-Related Anxiety (3-point scale, 1 = not at all, 3 = very much)

  At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

• Perceived Urgency to Act (3-point scale, 1 = not at all, 3 = very much)

  At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

• Perceived Helpfulness of Consultation (3-point scale, 1 = not at all, 3 = very much)

  At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

Other Outcomes (8)

• Physician Surgical Recommendation Rating (5-point scale, 1 = very weak, 3 = very strong)

  within 24 hours of initial outpatient consultation

• Presenting Visual Acuity (Study Eye)

  Baseline (initial outpatient consultation)

• Best Corrected Visual Acuity (Study Eye)

  Baseline (initial outpatient consultation)

Study Arms (2)

Structured Self-Reflection (Intervention)

EXPERIMENTAL

Participants receive a structured prompt via an online questionnaire asking them to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept elective cataract surgery. For example: "When I can confirm that my children will be available for 3 days post-surgery, I would be willing to undergo the operation." This intervention guides participants to actively define a personal pathway toward the surgical decision

Behavioral: Structured Surgical Planning Self-Reflection

No Writing Task (Control)

NO INTERVENTION

After reading the same standardized introductory paragraph about cataract diagnosis and treatment as the intervention group, control participants proceed directly to the follow-up questionnaire items without any writing task. All subsequent questionnaire items are identical to those completed by the intervention group.

Interventions

Structured Surgical Planning Self-Reflection BEHAVIORAL

Participants 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.

Structured Self-Reflection (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosed with one of the following: age-related cataract, complicated cataract, traumatic cataract, metabolic cataract, or congenital cataract 2. Age 18+ years 3. Baseline intraocular pressure (IOP) ≤ 21 mmHg 4. Axial length 20-30 mm 5. No intraocular surgery within the past 3 months 6. Meets at least ONE of the following functional criteria:
• 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
• Cataract interfering with fundus examination/treatment (e.g., diabetic retinopathy, macular disease, uveitis)
• Lens with risk of inducing glaucoma (shallow anterior chamber with family history or fellow-eye history of angle-closure, lens dislocation/subluxation, hypermature cataract)

You may not qualify if:

• Already decided to undergo or decline surgery at time of initial consultation

Sponsors & Collaborators

• Tongji University: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Y. Charles Zhang

CONTACT

+86 13262886498; yizi@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants are not informed of the study's true hypothesis or the existence of the other study arm. Outcome assessors (research assistants tracking surgical registration) are blinded to group assignment. The three treating physicians provide standardized information and are blinded to each patient's group allocation. Randomization is acheived through the survey platform.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 12 months after publication
• Access Criteria: all information can be requested by emailing Charles Zhang