RCT: Impact of Preop Video on Patient Preparedness for Surgery
Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Tampa、Florida、美国、33606
- University of South Florida Urogynecology clinic
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
|
Patients will watch preoperative instructional video
|
|
无干预:No video
This arm will receive only the normal preoperative visit with the physician without the additional video
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
patients' preparedness for surgery
大体时间:prior to surgery (baseline)
|
patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery
|
prior to surgery (baseline)
|
|
Patient preparedness for surgery
大体时间:2 week postop visit
|
patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
|
2 week postop visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
patient satisfaction
大体时间:2 weeks postop
|
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
|
2 weeks postop
|
|
perception of time
大体时间:prior to surgery (baseline)
|
patients' perception of time spent with healthcare team
|
prior to surgery (baseline)
|
|
Actual facetime spent
大体时间:prior to surgery (baseline)
|
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
|
prior to surgery (baseline)
|
|
QOL
大体时间:2 weeks postop
|
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
|
2 weeks postop
|
|
POPQ
大体时间:2 weeks postop
|
Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
|
2 weeks postop
|
|
Patient satisfaction
大体时间:prior to surgery (baseline)
|
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
|
prior to surgery (baseline)
|
合作者和调查者
调查人员
- 首席研究员:Kristie Greene, MD、University of South Florida
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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