- ICH GCP
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- Essai clinique NCT02076360
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Florida
-
Tampa, Florida, États-Unis, 33606
- University of South Florida Urogynecology clinic
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Preop Video
This arm will watch an instructional video in addition to their normal preoperative visit with the physician.
|
Patients will watch preoperative instructional video
|
Aucune intervention: No video
This arm will receive only the normal preoperative visit with the physician without the additional video
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
patients' preparedness for surgery
Délai: 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
Délai: 2 week postop visit
|
patients' feelings of preparedness for surgery as determined by a postoperative patient preparedness questionnaire for pelvic surgery
|
2 week postop visit
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
patient satisfaction
Délai: 2 weeks postop
|
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
|
2 weeks postop
|
perception of time
Délai: prior to surgery (baseline)
|
patients' perception of time spent with healthcare team
|
prior to surgery (baseline)
|
Actual facetime spent
Délai: prior to surgery (baseline)
|
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
|
prior to surgery (baseline)
|
QOL
Délai: 2 weeks postop
|
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
|
2 weeks postop
|
POPQ
Délai: 2 weeks postop
|
Objective measures of success will be determined using the Pelvic organ prolapse quantification (POPQ to quantify prolapse)
|
2 weeks postop
|
Patient satisfaction
Délai: prior to surgery (baseline)
|
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
|
prior to surgery (baseline)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kristie Greene, MD, University of South Florida
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00013617
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