Effect of Surgical Planning Prompts on Elective Surgery Acceptance Rate

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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, co

Первичные конечные точки

• Rate of Surgical Registration Within 6 Months [Срок оценки: 6 months from initial outpatient consultation]

Вторичные конечные точки (6)

• Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)]
• Semantic Content Analysis of Written Responses [Срок оценки: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)]

Критерии участия

Критерии включения

• 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:

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07544641 · elective surgery cataract

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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