Impact of Patient Surgical Planning on Elective Surgery Acceptance Rate: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 268
- 主要终点
- Rate of Surgical Registration Within 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Diagnosed with one of the following: age-related cataract, complicated cataract, traumatic cataract, metabolic cataract, or congenital cataract
- •Age 18+ years
- •Baseline intraocular pressure (IOP) ≤ 21 mmHg
- •Axial length 20-30 mm
- •No intraocular surgery within the past 3 months
- •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)
排除标准
- •Already decided to undergo or decline surgery at time of initial consultation
研究组 & 干预措施
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
干预措施: Structured Surgical Planning Self-Reflection (Behavioral)
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.
结局指标
主要结局
Rate of Surgical Registration Within 6 Months
时间窗: 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.
次要结局
- 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))
- Semantic Content Analysis of Written Responses(At time of questionnaire completion (Within 48 hours post-initial outpatient consultation))
研究者
Charles Zhang, PhD
Research Professor
Tongji University