Effect of Surgical Planning Prompts on Elective Surgery Acceptance Rate

April 15, 2026 updated by: Charles Zhang, PhD, Tongji University

Impact of Patient Surgical Planning on Elective Surgery Acceptance Rate: A Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Shared Decision-Making (SDM) tools for elective surgery often include exercises that ask patients to clarify under what conditions they would choose surgery. While such prompts have been effective for promoting medication adherence and vaccination, elective surgery is a higher-stakes decision involving pain, recovery, and cost concerns. A preliminary study of 60 patients found that 16.7% of controls versus 0% of intervention participants registered for surgery within 4 months, raising the hypothesis that structured self-reflection may inadvertently reduce surgical uptake by heightening patients' concerns.

Both groups first read a standardized paragraph explaining their cataract diagnosis and the availability of phacoemulsification surgery. The intervention group then receives a structured prompt asking them to write in detail about the specific conditions under which they would feel confident choosing surgery (e.g., "When I can confirm post-operative care from family for 3 days, I would be willing to proceed"). The control group does not receive a writing task and proceeds directly to the follow-up questionnaire items, which are identical across groups.

Three treating physicians each recruit from their own outpatient clinics within the same hospital. Each physician provides standardized, non-directive explanations of the condition and treatment options, and independently rates their degree of surgical recommendation for each of their patients based on their clinical judgment of surgical appropriateness. These physician recommendation ratings are included as covariates in the analysis. Baseline ophthalmic clinical measures - including visual acuity, best corrected visual acuity (BCVA), presence of fundus pathology or other ocular comorbidities, BCVA of the contralateral eye, cataract type and grade, and intraocular pressure - are also recorded and may be included as covariates.

After questionnaire completion, research assistants will track whether each participant registers for surgery within 6 months. Following surgery or the 6-month endpoint (whichever is earlier), participants will be fully debriefed and asked for informed consent. Data from participants who decline consent will be destroyed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. 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:

    1. Best Corrected Visual Acuity (BCVA) ≤ 0.5 and vision loss primarily attributable to cataract
    2. Posterior subcapsular cataract with patient-reported significant impact from glare, halos, or impaired night driving
    3. Patient-reported significant decrease in contrast sensitivity
    4. Anisometropia or refractive error, and patient reports inability to accept spectacle correction impacting reading, daily chores, TV viewing, driving, or outdoor activities
    5. Cataract interfering with fundus examination/treatment (e.g., diabetic retinopathy, macular disease, uveitis)
    6. Lens with risk of inducing glaucoma (shallow anterior chamber with family history or fellow-eye history of angle-closure, lens dislocation/subluxation, hypermature cataract)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Structured Self-Reflection (Intervention)
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
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.
No Intervention: No Writing Task (Control)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Surgical Registration Within 6 Months
Time Frame: 6 months from initial outpatient consultation
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much)
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Patient-reported level of understanding of their cataract condition following the outpatient consultation, measured via a single-item self-assessment in the online questionnaire.
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)
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Patient-reported sense of having a clear plan regarding subsequent treatment for their eye condition, measured via a single-item self-assessment.
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)
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Patient-reported level of anxiety about their current cataract condition, measured via a single-item self-assessment.
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)
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Patient-reported perceived urgency of taking the next step for their cataract condition, measured via a single-item self-assessment.
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)
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Patient-reported overall assessment of how helpful the outpatient visit was, measured via a single-item self-assessment.
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Semantic Content Analysis of Written Responses
Time Frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Qualitative and quantitative analysis of the text written by intervention-group participants in the structured self-reflection task, examining themes, specificity, emotional valence, and their correlation with surgical uptake.
At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physician Surgical Recommendation Rating (5-point scale, 1 = very weak, 3 = very strong)
Time Frame: within 24 hours of initial outpatient consultation

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
within 24 hours of initial outpatient consultation
Presenting Visual Acuity (Study Eye)
Time Frame: Baseline (initial outpatient consultation)
logMAR of the presenting visual acuity of the study eye measured using a standardized chart.
Baseline (initial outpatient consultation)
Best Corrected Visual Acuity (Study Eye)
Time Frame: Baseline (initial outpatient consultation)
logMAR of the best corrected visual acuity of the study eye following refraction.
Baseline (initial outpatient consultation)
Best Corrected Visual Acuity (Contralateral Eye)
Time Frame: Baseline (initial outpatient consultation)
logMAR of the corrected visual acuity of the non-study eye measured using a standardized chart.
Baseline (initial outpatient consultation)
Intraocular Pressure (Study Eye)
Time Frame: Baseline (initial outpatient consultation)
mmHg of the intraocular pressure measured using tonometry.
Baseline (initial outpatient consultation)
Presence of fundus pathology or other ocular comorbidities as assessed during clinical examination.
Time Frame: Baseline
Proportion of participants with ≥1 comorbidity (%)
Baseline
Cataract Morphological Type
Time Frame: Baseline
Classification of cataract type (e.g., nuclear, cortical, posterior subcapsular).
Baseline
Cataract Severity Grade
Time Frame: Baseline
Cataract severity graded using LOCS III.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • elective surgery cataract

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all the primary, secondery, and other outcome measures.

IPD Sharing Time Frame

Starting 12 months after publication

IPD Sharing Access Criteria

all information can be requested by emailing Charles Zhang

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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