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.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida Urogynecology clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
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Sem intervenção: No video
This arm will receive only the normal preoperative visit with the physician without the additional video
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
patients' preparedness for surgery
Prazo: prior to surgery (baseline)
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patients' feelings of preparedness for surgery as determined by a preoperative patient preparedness questionnaire for pelvic surgery
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prior to surgery (baseline)
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Patient preparedness for surgery
Prazo: 2 week postop visit
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
patient satisfaction
Prazo: 2 weeks postop
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patient satisfaction as determined by completion of an adapted postoperative satisfaction questionnaire
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2 weeks postop
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perception of time
Prazo: prior to surgery (baseline)
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patients' perception of time spent with healthcare team
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prior to surgery (baseline)
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Actual facetime spent
Prazo: prior to surgery (baseline)
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Actual facetime spent between physician and patient during preoperative counseling session measured in minutes
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prior to surgery (baseline)
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QOL
Prazo: 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
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POPQ
Prazo: 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
Prazo: prior to surgery (baseline)
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patient satisfaction as determined by completion of an adapted preoperative satisfaction questionnaire
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prior to surgery (baseline)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristie Greene, MD, University of South Florida
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00013617
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Ensaios clínicos em Prolapso
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Medical University of ViennaRecrutamentoProlapso de órgãos pélvicos | Cistocele | Prolapso Vaginal | Cistocele, linha média | Prolaps BexigaÁustria
Ensaios clínicos em Preoperative Video
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Dartmouth-Hitchcock Medical CenterRecrutamento
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Dartmouth-Hitchcock Medical CenterConcluídoQueimadura por frio | Mão congelada | Pé GeladoEstados Unidos