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Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures

29 de octubre de 2020 actualizado 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.

Descripción general del estudio

Estado

Desconocido

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Anticipado)

78

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Women planning on undergoing a hysteroscopy procedure

Exclusion Criteria:

  • Women NOT planning on undergoing a hysteroscopy procedure

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Comprehension of their Upcoming Surgery
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Preparedness for their Upcoming Surgery
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Eliane Shore, MD, Unity Health Toronto

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de noviembre de 2020

Finalización primaria (Anticipado)

1 de noviembre de 2021

Finalización del estudio (Anticipado)

1 de noviembre de 2021

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2020

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2020

Publicado por primera vez (Actual)

4 de noviembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20-215

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Patient Education Platform

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