Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- patients' preparedness for surgery
研究概览
简要总结
This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes.
The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit.
Objective:
A. Primary Aim(s):
• To determine if patients feel more prepared for surgery with addition of preoperative patient education video
B. Secondary Aim(s):
- To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery
- To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video
- To determine if actual patient-physician time spent counseling differs between groups
- To determine if patient preparedness is correlated with objective surgical outcomes
- To determine if patient preparedness is correlated with patient symptom improvement scores after surgery
Hypothesis:
The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
- •It is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned
- •English speaking
- •Willing and able to provide written and informed consent
排除标准
- •Women <18
- •Not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy
- •Non-English speaking
- •Unable or unwilling to provide written and informed consent
研究组 & 干预措施
Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
干预措施: Preoperative Video (Behavioral)
No video
This arm will receive only the normal preoperative visit with the physician without the additional video
结局指标
主要结局
patients' preparedness for surgery
时间窗: prior to surgery (baseline)
patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery
Patient preparedness for surgery
时间窗: 2 week postop visit
patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
次要结局
- perception of time(prior to surgery (baseline))
- POPQ(2 weeks postop)
- Actual facetime spent(prior to surgery (baseline))
- QOL(2 weeks postop)
- Patient satisfaction(prior to surgery (baseline))
- patient satisfaction(2 weeks postop)