Engaging Patients in Tobacco Cessation Resources in Dental Settings (ENGAGE)
22 de junio de 2022 actualizado por: HealthPartners Institute
A Clinic-randomized Trial of a Clinical Decision Support System to Improve Dental Provider Delivery of Brief Tobacco Interventions and Quitline Referrals
The overarching goal of this project is to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling.
Using a stratified, group-randomized, controlled, 2-arm trial conducted in two settings, the investigators will compare smoking-related clinical decision support (CDS) to usual care.
Descripción general del estudio
Descripción detallada
This project aims to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling.
The study team will evaluate the effectiveness of clinical decision support (CDS) to improve dental provider delivery of brief tobacco interventions and referrals to tobacco quitlines for further tobacco counseling.
The CDS will generate personalized, evidence-based recommendations for dentists and dental hygienists to actively engage their smoking patients in the course of usual dental care.
Subsequently, the study team will assess the tobacco cessation actions of smokers using patient-centered outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
56
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
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Dentistry
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Minnesota
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Bloomington, Minnesota, Estados Unidos, 55425
- HealthPartners Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15261
- University of Pittsburgh School of Dental Medicine
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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
No
Géneros elegibles para el estudio
Todos
Descripción
DENTAL STUDENTS AND DENTAL HYGIENE STUDENTS
Inclusion Criteria:
- 3rd and 4th year predoctoral students or dental hygiene students enrolled at selected dental schools
PRIVATE PRACTICE DENTISTS & HYGIENISTS
Inclusion Criteria:
- General practice dentists or dental hygienists practicing at selected private practice clinics
Exclusion Criteria:
- Providers not able or willing to record current tobacco use status in their electronic health record
- Providers affiliated with selected dental schools who hold a current teaching or clinical position
PATIENTS
Inclusion Criteria:
- Current cigarette smokers
Exclusion Criteria:
- patients requesting to opt out of research
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Usual Care
Usual care, practitioners review clinical guidelines for tobacco during consent process.
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Experimental: Clinical Decision Support
The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
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The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment
Periodo de tiempo: within a week of the index dental encounter
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Composite of provider actions reported by patient regarding delivery of brief interventions and/or referral to treatment.
These actions included that the provider 1) delivered a brief smoking intervention by discussing, a)developing a quit plan or b)setting a quit date or c)using medications to help patients quit or d)discussed strategies for quitting.
The provider made a 2) referral to a quitline; a)provided information about how to contact a tobacco quitline or b) arranged for the patient to be contacted by the tobacco quit line for smoking cessation.
The composite is satisfied if the patient reports that any of the intervention activities or referral was delivered by the provider.
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within a week of the index dental encounter
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Smokers With Initial Actions Related to Cessation
Periodo de tiempo: within a week of index dental encounter
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Composite of patient-reported actions of smokers with initial actions related to cessation.
This composite is met if the patient reported that they contacted a smoking cessation quitline, set a quit date, developed a plan to quit, or is starting nicotine replacement or other medication to help quit within 1-7 days of their index dental visit.
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within a week of index dental encounter
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Percentage of Smokers With Long-term Actions Related to Cessation
Periodo de tiempo: within six-months of index dental encounter
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Composite of patient-reported actions of smokers with long-term actions related to cessation.
This composite includes whether the patient reported that they quit smoking (stopped smoking for more than one day because they were trying to stop smoking), or reduced their smoking use (50% reduction in amount smoked at 6 months compared to baseline).
This composite is satisfied if the patient reports that they have done any of these actions within the 6 months +/- 1 week period between the index dental visit and the date of the second patient survey.
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within six-months of index dental encounter
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Heiko Spallek, DMD,PhD,MSBA, University of Sydney
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.
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)
29 de marzo de 2019
Finalización primaria (Actual)
30 de diciembre de 2020
Finalización del estudio (Actual)
30 de junio de 2021
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2018
Publicado por primera vez (Actual)
4 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- A15-107
- U01DE026135 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Sharing of study outputs and resources is an essential element of this research.
To facilitate the conduct of future research, we will make available de-identified datasets and technical resources from the completed project in a manner consistent with human subject protection and HIPAA privacy regulations.
These resources will be subject to requirements imposed by the governing Institutional Review Board (IRB) and our organizational legal requirements.
Marco de tiempo para compartir IPD
Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
Criterios de acceso compartido de IPD
Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician.
Study publications will note the method for requesting the study data and technical materials.
The study statistician will provide data and accompanying files in an archived zip format to requesters via email.
Data will not be stored in a public repository.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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. .