RCT: Impact of Preop Video on Patient Preparedness for Surgery

May 10, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida Urogynecology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
Behavioral: Preoperative Video
Patients will watch preoperative instructional video
No Intervention: No video
This arm will receive only the normal preoperative visit with the physician without the additional video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prior to surgery (baseline)
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
2 week postop visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 2 weeks postop
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
2 weeks postop
perception of time
Time Frame: prior to surgery (baseline)
patients' perception of time spent with healthcare team
prior to surgery (baseline)
Actual facetime spent
Time Frame: prior to surgery (baseline)
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
prior to surgery (baseline)
QOL
Time Frame: 2 weeks postop
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
2 weeks postop
POPQ
Time Frame: 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
Time Frame: prior to surgery (baseline)
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
prior to surgery (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Kristie Greene, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00013617

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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