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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida Urogynecology clinic
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
|
Sin intervención: No video
This arm will receive only the normal preoperative visit with the physician without the additional video
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
patients' preparedness for surgery
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
patient satisfaction
Periodo de tiempo: 2 weeks postop
|
patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
|
2 weeks postop
|
|
perception of time
Periodo de tiempo: prior to surgery (baseline)
|
patients' perception of time spent with healthcare team
|
prior to surgery (baseline)
|
|
Actual facetime spent
Periodo de tiempo: prior to surgery (baseline)
|
Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
|
prior to surgery (baseline)
|
|
QOL
Periodo de tiempo: 2 weeks postop
|
Completion of validated condition specific QOL measures (ie. the Patient Global Impression of Improvement [PGI-I])
|
2 weeks postop
|
|
POPQ
Periodo de tiempo: 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
Periodo de tiempo: prior to surgery (baseline)
|
patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
|
prior to surgery (baseline)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristie Greene, MD, University of South Florida
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00013617
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