- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07716280
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS)
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS) - PATIENT
The long-term goal of this program of research is to increase the reach of Lung Cancer Screening (LCS) among low-resource healthcare settings and populations. The proposed project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in three Utah safety-net healthcare system clinics.
LUNG-IS employs a comprehensive conceptual model with theories, models, and frameworks of implementation and behavioral science, uses rigorous mixed-methods to evaluate factors that influence implementation of LCS, and uses patient navigation to facilitate clinic-community linkages.
LUNG-IS leverages existing pathways to care and Centralized Hub infrastructure that enables eligibility assessment, LCS Shared Decision Making (SDM) with clinical decision support, screening referral, and screening logistics assistance to help overcome barriers to LCS completion. The Centralized Hub model uses ubiquitous technologies (i.e., text messaging/telehealth) to enable patients to be assessed for LCS eligibility, engage in SDM if eligible, and be referred for LCS. For patients who decide to complete LCS, they will be provided patient navigation via Community Health Workers designed to address logistical barriers, hesitancy, and financial constraints around completing LCS.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Indy Li, MS
- Número de teléfono: 801-213-5697
- Correo electrónico: indy.li@hci.utah.edu
Ubicaciones de estudio
-
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Reclutamiento
- Huntsman Cancer Institute/ University of Utah
-
Contacto:
- Indy Li, MS
- Número de teléfono: 801-213-5697
- Correo electrónico: indy.li@hci.utah.edu
-
Investigador principal:
- Chelsey Schlechter, MPH, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Current or former, male and female, smokers.
- Age 50-80.
- Primary language English or Spanish.
- Have a phone that can send/receive text messages.
Exclusion Criteria:
- Patients who have never smoked.
- Patients who are under the age of 50 or above the age of 80.
- Primary language other than English or Spanish.
- Do not have access to a phone that can send/receive text messages.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Stage 1: TM+
Basic text messages sent directly to the patient's cell phone.
|
Basic text messages sent directly to the patient's cell phone.
|
|
Otro: Stage 1: TM+, CA
Basic text messages sent directly to the patient's cell phone.
Also includes the option for chat bot to answer frequently asked LCS questions.
|
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
|
|
Otro: Stage 1: TM+, Video
Basic text messages sent directly to the patient's cell phone.
Also includes the option for an educational video about LCS.
|
Basic text messages sent directly to the patient's cell phone.
Educational video about LCS.
|
|
Otro: Stage 1: TM+, CA, Video
Basic text messages sent directly to the patient's cell phone. Also includes the option for chat bot to answer frequently asked LCS questions and option for educational video about LCS. Patients who complete SDM and are referred to LCS will also be assigned to one of the following conditions. Descriptions of these conditions are as follows: |
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
Educational video about LCS.
|
|
Otro: Stage 2: TM+, RPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and reactive patient navigation to help get to the LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Reactive patient navigation to help get to the LCS appointment.
|
|
Otro: Stage 2:TM+, PPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and proactive patient navigation to help get to the LCS appointment. Patients who need transportation financial assistance will receive transportation vouchers to help get them to and from their LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Proactive patient navigation to help get to the LCS appointment.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of Implementation Strategies on Lung Cancer Screening (LCS) eligibility screening
Periodo de tiempo: up to 15 weeks after study enrollment
|
Evaluate the impact of implementation strategies on Lung Cancer Screening (LCS) eligibility screening.
This outcome measure will report the proportion of participants who complete LCS eligibility screening.
|
up to 15 weeks after study enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion
Periodo de tiempo: up to 7 weeks after completion of LCS eligibility screen
|
Evaluate the impact of implementation strategies on Shared Decision Making (SDM) completion.
This outcome measure will report the proportion of patients who complete SDM.
|
up to 7 weeks after completion of LCS eligibility screen
|
|
Impact of Implementation Strategies on LCS Completion
Periodo de tiempo: up to 6 months after placement of LCS referral
|
Evaluate the impact of implementation strategies on LCS completion.
This outcome measure will report the proportion of participants who complete LCS.
|
up to 6 months after placement of LCS referral
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Tecnología, industria y agricultura
- Tecnología
- Grabación de cinta
- Medios audiovisuales
- Tecnología educativa
- Televisión
- Grabación de video
Otros números de identificación del estudio
- 187448
- 1U48DP006855-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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