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RCT: Impact of Preop Video on Patient Preparedness for Surgery

Primary Purpose

Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative Video
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prolapse focused on measuring Preoperative counseling, Patient satisfaction, Prolapse, Sacrocolpopexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida Urogynecology clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preop Video

No video

Arm Description

This arm will watch an instructional video in addition to their normal preoperative visit with the physician.

This arm will receive only the normal preoperative visit with the physician without the additional video

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

patient satisfaction
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
perception of time
patients' perception of time spent with healthcare team
Actual facetime spent
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
QOL
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
POPQ
Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
Patient satisfaction
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire

Full Information

First Posted
September 20, 2013
Last Updated
May 10, 2019
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02076360
Brief Title
RCT: Impact of Preop Video on Patient Preparedness for Surgery
Official Title
Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse
Keywords
Preoperative counseling, Patient satisfaction, Prolapse, Sacrocolpopexy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preop Video
Arm Type
Experimental
Arm Description
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
Arm Title
No video
Arm Type
No Intervention
Arm Description
This arm will receive only the normal preoperative visit with the physician without the additional video
Intervention Type
Behavioral
Intervention Name(s)
Preoperative Video
Intervention Description
Patients will watch preoperative instructional video
Primary Outcome Measure Information:
Title
patients' preparedness for surgery
Description
patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery
Time Frame
prior to surgery (baseline)
Title
Patient preparedness for surgery
Description
patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
Time Frame
2 week postop visit
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
Time Frame
2 weeks postop
Title
perception of time
Description
patients' perception of time spent with healthcare team
Time Frame
prior to surgery (baseline)
Title
Actual facetime spent
Description
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
Time Frame
prior to surgery (baseline)
Title
QOL
Description
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
Time Frame
2 weeks postop
Title
POPQ
Description
Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
Time Frame
2 weeks postop
Title
Patient satisfaction
Description
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
Time Frame
prior to surgery (baseline)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristie Greene, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida Urogynecology clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28431952
Citation
Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18.
Results Reference
derived

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RCT: Impact of Preop Video on Patient Preparedness for Surgery

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