Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
29 de outubro de 2020 atualizado por: Unity Health Toronto
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction.
When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting.
Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference.
The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
Informed consent is dependent on three criteria; the patient must be competent, relevant information including risks, benefits and alternatives must be clearly communicated, and the acceptance of treatment must be voluntary. The consent process usually occurs in the office setting through physician-led verbal communication. Despite satisfying the three criteria of informed consent, many patients leave the office with an inadequate understanding of the treatment they have consented to.
The purpose of this study is to use an interactive patient education pathway as an adjunct to the informed consent process for patients undergoing hysteroscopy. This will be done using a randomized controlled trial design.
Patients will be randomized to the control group (standard consent process) or the education group (standard consent process augmented by access to an interactive hysteroscopy teaching platform).
All patients will undergo the standard physician-led informed consent process. Patients from both groups will be asked to complete a post-informed consent questionnaire to assess their understanding of their upcoming procedure, preparedness for the procedure, and satisfaction with the informed consent process, be that through the traditional method or the interactive patient education portal.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
78
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Women planning on undergoing a hysteroscopy procedure
Exclusion Criteria:
- Women NOT planning on undergoing a hysteroscopy procedure
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Patient Education Group
Patients in this group will undergo the standard physician-led informed consent process and then be provided with an interactive patient education platform for hysteroscopy on a tablet available in the clinic for up to one hour of time.
After the patient has explored the patient education platform, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process.
|
The patient education platform for hysteroscopy surgery is a website platform which has patient education materials regarding hysteroscopy procedures in the format of pictures, videos, and text.
Information on this platform includes anatomy of the surgery area, what to expect, reasons for the surgery, ways to prepare for the surgery, and recovering from the surgery.
|
|
Sem intervenção: Standard Consent Group
Patients in this group will undergo the standard physician-led informed consent process only.
After they have consented to the surgery, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Comprehension of their Upcoming Surgery
Prazo: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
Patient comprehension of their upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group).
The survey will ask the patient to name a benefit, risk, discomfort, and indication of the procedure, as well as a consequence to not having the procedure.
One point will be given for each correct answer.
Comprehension will be measured using a mean.
|
After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Preparedness for their Upcoming Surgery
Prazo: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
Patient preparedness for the upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group).
Patients will be asked to indicate how prepared they feel on a 5-point Likert scale with 1 = Very Prepared and 5 = Very Unprepared.
|
After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
|
Patient Satisfaction with the Consent Process
Prazo: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
Satisfaction with the consent process will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group).
Patients will be asked how much time they think was spent on the consent process (vs.
actual time spent, measured using a stop watch).
Difference between perceived time and actual time will be calculated.
Patients will also be asked if certain aspects of the consent process were covered by the doctor during the discussion (e.g.
"Was the procedure explained to you?", "Were the risks explained to you?").
Answer options will be "Yes/No".
Patients will be asked if they received enough information to make a sound decision and if their questions were answered to their satisfaction.
Answer options will be "Yes/No" Patient satisfaction will be determined using frequency counts.
|
After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Eliane Shore, MD, Unity Health Toronto
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de novembro de 2020
Conclusão Primária (Antecipado)
1 de novembro de 2021
Conclusão do estudo (Antecipado)
1 de novembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
19 de outubro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de outubro de 2020
Primeira postagem (Real)
4 de novembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 20-215
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .