Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01
28 de abril de 2026 actualizado por: David Adler, University of Rochester
Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01
This randomized clinical trial evaluates the effectiveness of text messaging and facilitated referral strategies to increase lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.
The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.
The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1036
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
- Nombre: Peter Macdowell
- Número de teléfono: 585-274-1509
- Correo electrónico: peter_macdowell@urmc.rochester.edu
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 50 - 80
- ≥ 20 pack-year smoking history
- current smoker or quit within 15 years
- English/Spanish speaking
- Registered in the Emergency Department as a patient
Exclusion Criteria:
- Non-English/Spanish
- Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
- Lack of text-capable mobile phone and/or inability to use text function
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: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Basic Referral (enhanced control arm)
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening.
They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator.
If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.
|
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
|
|
Experimental: Basic Referral plus Text Messaging
Participants assigned to this arm will receive the basic referral as described in the previous arm.
In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening.
Patients will receive a total of 9 messages.
|
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
|
|
Comparador activo: Facilitated Referral
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.
|
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
|
|
Experimental: Facilitated Referral plus Text Messaging
Participants assigned to this arm will receive facilitated referral plus the series of text messages described above.
Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.
|
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Periodo de tiempo: Up to 120 Days After Enrollment
|
Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment.
Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up.
The outcome is reported as the proportion of participants who complete screening.
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Up to 120 Days After Enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Periodo de tiempo: Up to 120 Days After Enrollment
|
Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment.
The outcome is reported as the proportion of participants who participate in shared decision making.
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Up to 120 Days After Enrollment
|
|
Frequency of Reported Barriers to Lung Cancer Screening at 120 Days
Periodo de tiempo: 120 Days After Enrollment
|
Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results.
The outcome is reported as the number and proportion of participants reporting each barrier.
|
120 Days After Enrollment
|
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Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Periodo de tiempo: Up to 120 Days After Enrollment
|
Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability.
The outcome is reported as summary scores based on participant responses.
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Up to 120 Days After Enrollment
|
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Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Periodo de tiempo: 120 Days After Enrollment
|
Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness.
The outcome is reported as summary scores based on participant responses.
|
120 Days After Enrollment
|
|
Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days
Periodo de tiempo: 120 Days After Enrollment
|
Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider.
The outcome is reported as the number and proportion of participants reporting each facilitator.
|
120 Days After Enrollment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de marzo de 2027
Finalización primaria (Estimado)
1 de diciembre de 2030
Finalización del estudio (Estimado)
1 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FP00007604
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Undecided
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
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