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RCT: Impact of Preop Video on Patient Preparedness for Surgery

2019年5月10日 更新者:University of South Florida

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

地位

完全的

条件

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Tampa、Florida、美国、33606
        • University of South Florida Urogynecology clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2013年9月20日

首先提交符合 QC 标准的

2014年2月27日

首次发布 (估计)

2014年3月3日

研究记录更新

最后更新发布 (实际的)

2019年5月14日

上次提交的符合 QC 标准的更新

2019年5月10日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00013617

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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