RCT: Impact of Preop Video on Patient Preparedness for Surgery

NCT ID: NCT02076360

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Preop Video

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

Group Type EXPERIMENTAL

Preoperative Video

Intervention Type BEHAVIORAL

Patients will watch preoperative instructional video

No video

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative Video

Patients will watch preoperative instructional video

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristie Greene, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida Urogynecology clinic

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28431952 (View on PubMed)

Other Identifiers

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Pro00013617

Identifier Type: -

Identifier Source: org_study_id

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