Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Improving Cancer Patients' Insurance Choices (I Can PIC)

29 de abril de 2019 actualizado por: Washington University School of Medicine

Supporting Cancer Survivors' Health Insurance Marketplace Decisions

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

263

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
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

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 a 64 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Ability to read English
  • Diagnosed with cancer in the past 5 years
  • Residing in Missouri or Illinois

Exclusion Criteria:

  • Eligible for Medicaid or Medicare in Missouri or Illinois
  • Enrolled in the following types of health insurance plans: Medicare, Medicaid, TRICARE or other military healthcare, or Indian Health Services

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: I Can PIC
The I Can PIC website will be provided to participants randomized to the experimental/intervention group.
Conductual: I Can PIC
Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.
Otros nombres:
  • Decision Aid (DA)
Sin intervención: Attention Control
Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knowledge Score
Periodo de tiempo: Completed immediately after using I Can PIC
The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.
Completed immediately after using I Can PIC
Decision Self-efficacy
Periodo de tiempo: Completed immediately after using I Can PIC.
The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).
Completed immediately after using I Can PIC.
Certainty about Choice (Decisional Conflict Scale)
Periodo de tiempo: Completed immediately after using I Can PIC
The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.
Completed immediately after using I Can PIC

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health Insurance Literacy Measure
Periodo de tiempo: Completed immediately after using I Can PIC
Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.
Completed immediately after using I Can PIC
Health Insurance Literacy Measure
Periodo de tiempo: 3 month follow-up

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Choice of Health Insurance Plan
Periodo de tiempo: Completed immediately after using I Can PIC
Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.
Completed immediately after using I Can PIC
Choice of Health Insurance Plan
Periodo de tiempo: 3 month follow-up

Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Healthcare Utlization
Periodo de tiempo: 3 month follow-up
Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization
3 month follow-up
Knowledge Score
Periodo de tiempo: 3 month follow-up

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Certainty about Choice (Decisional Conflict Scale)
Periodo de tiempo: 3 month follow-up

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up

Colaboradores e Investigadores

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

Patrocinador

Washington University School of Medicine

Colaboradores

American Cancer Society, Inc.

Investigadores

  • Investigador principal: Mary C Politi, PhD, Washington University School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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 junio de 2018

Finalización primaria (Actual)

28 de febrero de 2019

Finalización del estudio (Actual)

28 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2018

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2018

Publicado por primera vez (Actual)

19 de julio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2019

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

29 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 201704045

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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 Cáncer

Ensayos clínicos sobre I Can PIC

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Malta

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir