RCT: Impact of Preop Video on Patient Preparedness for Surgery
Impact of Preoperative Patient Education Video on Patient Preparedness After Sacrocolpopexy: A Single Blind Randomized Controlled Trial
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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Florida
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Tampa, Florida, Verenigde Staten, 33606
- University of South Florida Urogynecology clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
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Patients will watch preoperative instructional video
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Geen tussenkomst: No video
This arm will receive only the normal preoperative visit with the physician without the additional video
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
patients' preparedness for surgery
Tijdsspanne: prior to surgery (baseline)
|
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
Tijdsspanne: 2 week postop visit
|
patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
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2 week postop visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
patient satisfaction
Tijdsspanne: 2 weeks postop
|
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
|
2 weeks postop
|
|
perception of time
Tijdsspanne: prior to surgery (baseline)
|
patients' perception of time spent with healthcare team
|
prior to surgery (baseline)
|
|
Actual facetime spent
Tijdsspanne: prior to surgery (baseline)
|
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
|
prior to surgery (baseline)
|
|
QOL
Tijdsspanne: 2 weeks postop
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Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
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2 weeks postop
|
|
POPQ
Tijdsspanne: 2 weeks postop
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Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
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2 weeks postop
|
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Patient satisfaction
Tijdsspanne: prior to surgery (baseline)
|
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
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prior to surgery (baseline)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kristie Greene, MD, University of South Florida
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00013617
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