RCT: Impact of Preop Video on Patient Preparedness for Surgery

Study Overview
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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.

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

Conditions
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Prolapse

Intervention / Treatment
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* Behavioral: Preoperative Video


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preop Video<br>This arm will watch an instructional video in addition to their normal preoperative visit with the physician. | Behavioral: Preoperative Video<br>* Patients will watch preoperative instructional video<br>|
| No Intervention: No video<br>This arm will receive only the normal preoperative visit with the physician without the additional video | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative counseling, Patient satisfaction, Prolapse, Sacrocolpopexy