- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05115916
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Colorectal cancer (CRC) is the second leading cause of death from cancers affecting both men and women in the United States. One in 17 Americans will suffer from CRC during his/her lifetime. Early detection by screening has been shown to reduce CRC mortality. Despite screening recommendations, the U.S. screening rate remains well below the national benchmark of 80% as established by the National Colorectal Cancer Roundtable. The U.S. Multi-Society Task Force (MSTF), however, does recommended FIT and colonoscopy as first line screening modalities for CRC in 2017. To help address the issue of suboptimal CRC screening, the investigators implemented an intervention utilizing the principles of behavioral economics to improve screening rates. Studies in behavioral economics and psychology indicate that how information or choice is framed impacts behavior in predictable ways, which has applications in health and medicine, including the design of CRC screening strategies. This project builds upon our institutions continued quality improvement efforts utilizing behavioral economics principles to improve CRC screening, through improving the choice architecture, framing and salience of information to incentivize routine screening.
For this project the investigators will leverage our electronic health records (EHR) patient portals to improve CRC screening. Specifically, the investigators developed an electronic primer within the EHR patient portal to alert patients due for CRC screening before arrival of a mailed FIT Kit. The investigators randomized implementation of the primer at the patient-level to determine whether the electronic primer improved CRC screening completion in patients enrolled in our mailed FIT program.
For our analysis, after summarizing our demographic data, the investigators plan to compare screening completion in the two study arms using an intention-to-treat analysis and t-tests. The investigators then plan a logistic regression and Cox proportional hazards model to compare time to screening utilization in the two study arms, controlling for age, sex, race, and ethnicity. Following this the investigators use Fisher's exact tests to compare completion of individual screening modalities in the two study arms. Lastly, the investigators plan a secondary, analysis to determine the impact of opening the portal message on screening utilization, using randomization arm as an instrumental variable. In this analysis the investigators compare the subset of patients in the intervention group that opened the portal primer message to the control group. P-values less than 0.05 are considered statistically significant.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Westwood, California, Estados Unidos, 90095
- UCLA Health Department of Medicine, Quality Office
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Managed care patient, 51-75 years old
- Active primary care provider at UCLA seen within last 3 years
Exclusion Criteria:
- Inactive MyChart status or mailing address at time of enrollment
- Died within follow up period
- Any high-risk features including first degree family members with CRC, personal history of adenomas, history of inflammatory bowel disease, and any genetic GI cancer syndromes.
- Exclusion from March 2020 cohort if received FIT mailer within past 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Standard of Care
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
|
|
|
Experimental: MyChart Message
This group will receive a message via EHR portal informing them about the incoming FIT Kit
|
In addition to the standard FIT mailer protocol, we will send randomized participants a message via their personal health portal.
Patients receive the primer approximately 1-2 weeks prior to arrival of the FIT kit, which informed patients about the incoming FIT Kit and instructed patients to complete and return the kit promptly.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Colorectal Cancer Screening Uptake
Periodo de tiempo: 6 months
|
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to screening
Periodo de tiempo: 6 months
|
Time (months) to screening uptake
|
6 months
|
|
Adopción del cribado del cáncer colorrectal por modalidad
Periodo de tiempo: 6 meses
|
Tasa de finalización del cribado de CRC por tipo de modalidad
|
6 meses
|
|
Effect of electronic primer message on CRC uptake among participants who opened
Periodo de tiempo: 6 months
|
Rate of completion of CRC screening among individuals who received the MyChart electronic primer.
|
6 months
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FITPrimer
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .