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Informed Consent Formats by Information Preference and Priority

24 de enero de 2018 actualizado por: Carnegie Mellon University
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.

Tipo de estudio

Intervencionista

Inscripción (Actual)

500

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.

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Carnegie Mellon University

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 18 Years Old or Older
  • Read and agreed to informed consent
  • Indicated desire to participate
  • Diagnosed with asthma
  • US resident

Exclusion Criteria:

  • Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Original
Participants will review the full-length, original consent form for the clinical trial.
Conductual: Original consent form
Participants will review the full-length, original consent form for the clinical trial.
Experimental: Shortened
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
Conductual: Shortened consent form
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
Experimental: Reordered
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
Conductual: Reordered, shortened consent form
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
Experimental: Highlighted
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
Conductual: Shortened consent form with a highlights box
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
Experimental: Interactive
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.
Conductual: Interactive, shortened consent form
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Score for high impact questions
Periodo de tiempo: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
through study completion, an average of 30 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Score for low impact questions
Periodo de tiempo: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 49 or lower on impact on willingness to enroll in a previous study.
through study completion, an average of 30 minutes
Total score for all questions
Periodo de tiempo: through study completion, an average of 30 minutes
Sum of correct answers (T/F) on full knowledge test.
through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer
Periodo de tiempo: through study completion, an average of 30 minutes
Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
through study completion, an average of 30 minutes
Scores for different information categories
Periodo de tiempo: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for each of the 20 information categories
through study completion, an average of 30 minutes
Effect of location on score
Periodo de tiempo: through study completion, an average of 30 minutes
Logistic regression coefficient of likelihood of predicting a correct answer, based upon the location on which the sentence appeared--uses only the shortened, and the reordered conditions. Note that sentences appearing in the introduction (which is the first section of all treatments) must be dropped, as there will be no variation in location.
through study completion, an average of 30 minutes
Decision to enroll
Periodo de tiempo: through study completion, an average of 30 minutes
Likert measure of participants hypothetical decision to enroll in the study
through study completion, an average of 30 minutes
Confidence in enrollment decision
Periodo de tiempo: through study completion, an average of 30 minutes
Likert measure of participants confidence in hypothetical decision to enroll in the study
through study completion, an average of 30 minutes
Satisfaction with consent structure
Periodo de tiempo: through study completion, an average of 30 minutes
Likert measure of participants satisfaction with the consent form
through study completion, an average of 30 minutes
Perception of investigator concern for well being
Periodo de tiempo: through study completion, an average of 30 minutes
Likert measure of participants belief in the investigator's concerns for the participant's well-being
through study completion, an average of 30 minutes
Perception of investigator transparency
Periodo de tiempo: through study completion, an average of 30 minutes
Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
through study completion, an average of 30 minutes
Participant's probability estimate of the likelihood that the treatment would help control their asthma
Periodo de tiempo: through study completion, an average of 30 minutes

Survey question of the following form:

'If you enrolled in the trial described in the consent form, what is the probability that the treatment could help control your asthma better, where 0% means "no chance at all of helping" and 100% means "would definitely help"?'

Participants provided with drop-down menu including values from 0% to 100% in increments of 1%.
through study completion, an average of 30 minutes

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant's free-response text describing what was learned from reading the informed consent document
Periodo de tiempo: through study completion, an average of 30 minutes

Survey question of the following form:

"What are some of the key things you learned from reading the informed consent document?"

Participants are then provided with an free-response text box where they are allowed to enter whatever text they want, as long as they enter some text. These responses will be coded by two independent coders, blinded to the treatment arms, using an emergent coding system to identify different topics that participants may raise.
through study completion, an average of 30 minutes

Colaboradores e Investigadores

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

Patrocinador

Carnegie Mellon University

Colaboradores

ICON plc

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 (Actual)

27 de noviembre de 2017

Finalización primaria (Actual)

31 de diciembre de 2017

Finalización del estudio (Actual)

31 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

8 de enero de 2018

Primero enviado que cumplió con los criterios de control de calidad

24 de enero de 2018

Publicado por primera vez (Actual)

31 de enero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de enero de 2018

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

24 de enero de 2018

Última verificación

1 de enero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • STUDY2017_00000268

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.

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. .

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