RCT: Impact of Preop Video on Patient Preparedness for Surgery

Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076360
• Other study ID #: Pro00013617
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse

Intervention

Behavioral:
• Preoperative Video
Patients will watch preoperative instructional video

Locations

Country	Name	City	State
United States	University of South Florida Urogynecology clinic	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients' preparedness for surgery	patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery	prior to surgery (baseline)
Primary	Patient preparedness for surgery	patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery	2 week postop visit
Secondary	patient satisfaction	patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire	2 weeks postop
Secondary	perception of time	patients' perception of time spent with healthcare team	prior to surgery (baseline)
Secondary	Actual facetime spent	Actual facetime spent between physician and patient during preoperative counseling session measured in minutes	prior to surgery (baseline)
Secondary	QOL	Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])	2 weeks postop
Secondary	POPQ	Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)	2 weeks postop
Secondary	Patient satisfaction	patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire	prior to surgery (baseline)