Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Shared decision making
研究概览
简要总结
The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.
详细描述
In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Masking was not performed as it was not feasible
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
- •Participants must be >18 years
- •Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum
排除标准
- •Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum
研究组 & 干预措施
3D-printed model arm
Surgeons in this arm will use a 3D-printed modular human torso model with a magnetically detachable colon and rectum to teach patients about the anatomy and proximity of colonic segments undergoing surgery, potential surgical complications, and operative procedures during the pre-operative consent.
干预措施: 3D-printed model (Other)
Standard care arm
Surgeons will employ the usual pre-operative counseling in this arm. This will include teaching patients about the anatomy, operative procedures, and potential surgical complications during the pre-operative consent using 2D images.
结局指标
主要结局
Shared decision making
时间窗: Within 30 minutes after the preoperative counselling session.
Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.
次要结局
- Change in patient anxiety(Within 30 minutes before and 30 minutes after the preoperative counselling session.)
- Change in patient knowledge using a self-developed questionnaire(Within 30 minutes before and 30 minutes after the preoperative counselling session.)
研究者
Aimal Khan
Assistant Professor of Surgery
Vanderbilt University Medical Center