Clinical trial NCT02076360: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: Preoperative counseling
Patient satisfaction
Prolapse
Sacrocolpopexy
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: patients' preparedness for surgery
timeFrame: prior to surgery (baseline)
measure: Patient preparedness for surgery
timeFrame: 2 week postop visit
Secondary outcomes:
measure: patient satisfaction
timeFrame: 2 weeks postop
measure: perception of time
timeFrame: prior to surgery (baseline)
measure: Actual facetime spent
timeFrame: prior to surgery (baseline)
measure: QOL
timeFrame: 2 weeks postop
measure: POPQ
timeFrame: 2 weeks postop
measure: Patient satisfaction
timeFrame: prior to surgery (baseline)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Urogynecology clinic
state: Florida
Study officials:
affiliation: University of South Florida
name: Kristie Greene, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.