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Clinical Trials/NCT02076360
NCT02076360
Completed
N/A

Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial

University of South Florida1 site in 1 country100 target enrollmentAugust 2013
ConditionsProlapse

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prolapse
Sponsor
University of South Florida
Enrollment
100
Locations
1
Primary Endpoint
patients' preparedness for surgery
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

patients' preparedness for surgery

Time Frame: 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

Time Frame: 2 week postop visit

patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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