RCT: Impact of Preop Video on Patient Preparedness for Surgery

NCT02076360 | Completed DMC

• 1 other identifier: Pro00013617
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolapse

Keywords

Preoperative counseling; Patient satisfaction; Prolapse; Sacrocolpopexy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• patient satisfaction

  2 weeks postop

• perception of time

  prior to surgery (baseline)

• Actual facetime spent

  prior to surgery (baseline)

• QOL

  2 weeks postop

• POPQ

  2 weeks postop

Study Arms (2)

Preop Video

EXPERIMENTAL

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

Behavioral: Preoperative Video

No video

NO INTERVENTION

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

Interventions

Preoperative Video BEHAVIORAL

Patients will watch preoperative instructional video

Preop Video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida Urogynecology clinic

Tampa, Florida, 33606, United States

Location

Related Publications (1)

• 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.

  PMID: 28431952 DERIVED

MeSH Terms

Conditions

Prolapse; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristie Greene, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: March 3, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 14, 2019

Record last verified: 2016-05

Locations

US (1)