RCT: Impact of Preop Video on Patient Preparedness for Surgery

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02076360
Collaborator
(none)
100
1
2
40
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Preoperative Video
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. patients' preparedness for surgery [prior to surgery (baseline)]

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

  2. Patient preparedness for surgery [2 week postop visit]

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

Secondary Outcome Measures

  1. patient satisfaction [2 weeks postop]

    patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire

  2. perception of time [prior to surgery (baseline)]

    patients' perception of time spent with healthcare team

  3. Actual facetime spent [prior to surgery (baseline)]

    Actual facetime spent between physician and patient during preoperative counseling session measured in minutes

  4. QOL [2 weeks postop]

    Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])

  5. POPQ [2 weeks postop]

    Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)

  6. Patient satisfaction [prior to surgery (baseline)]

    patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Florida Urogynecology clinic Tampa Florida United States 33606

Sponsors and Collaborators

  • University of South Florida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of South Florida
ClinicalTrials.gov Identifier:
NCT02076360
Other Study ID Numbers:
  • Pro00013617
First Posted:
Mar 3, 2014
Last Update Posted:
May 14, 2019
Last Verified:
May 1, 2016
Keywords provided by University of South Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2019