- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00865553
Computer-Assisted Stop-Smoking Program in Helping Doctors Counsel Patients Who Smoke Cigarettes
Clinical Testing of a Decision Support System for Tobacco Use Treatment
RATIONALE: A computer-assisted stop-smoking program may help doctors counsel patients who smoke and may help increase the number of patients who stop smoking.
PURPOSE: This phase II trial is studying how well a computer-assisted stop-smoking program works in helping doctors counsel patients who smoke cigarettes.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
- Test the hypothesis that the clinical decision support system will improve the rate at which physicians assist their patients with smoking cessation by providing information and recommendations on smoking cessation resources.
- Assess whether exposure to information and recommendations facilitated by the smoking cessation-personal digital assistant (SC-PDA) will increase the rate at which patients make at least 1 attempt to quit smoking in the month following the physician visit.
- Assess whether exposure to information and recommendations facilitated by the SC-PDA will increase the reported use of counseling and pharmacotherapy during those attempts over that observed with a smoking status identification system alone.
- Evaluate the acceptance of the SC-PDA into the workflow of ambulatory care clinics.
OUTLINE: In weeks 1-12, physicians have access to a smoking status identification system (SSID) that reminds the physician the smoking status of the patient they are evaluating. In weeks 6-12, physicians have access to a computerized smoking cessation clinical decision support system using a hand-held personal digital assistant (SC-PDA) that they can use in the exam room with their patients who smoke. The SC-PDA system assists physicians in recommending and prescribing approved pharmacotherapy; facilitates referral of patients to local counseling resources; prints a tailored handout for a patient listing specific recommendations, instructions, and cessation resources; and generates the necessary documentation to support billing for this intervention.
Patients who visit their physician in weeks 2-6 or weeks 8-12 complete a survey after their clinic visit and undergo a telephone interview 1 month later. Physicians undergo interviews and focus groups are conducted with clinic staff in weeks 12-16.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Vermont
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Burlington, Vermont, Estados Unidos, 05405-0110
- Reclutamiento
- Vermont Cancer Center at University of Vermont
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Contacto:
- Clinical Trials Office - Vermont Cancer Center at University o
- Número de teléfono: 802-656-2178
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Current smoker, defined as self-reported smoking most days or every day (patient)
- Seeks care at a participating Fletcher Allen Health Care primary care clinic (patient)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Physician adherence to the United States Public Health Service's Tobacco Use and Dependence Treatment guideline (USPHS Guideline) as measured by the patient exit survey
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Patient perception of physician as measured by the patient exit survey and telephone interview
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Prevalence of smoking and associated variables as measured by the patient exit survey
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Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview
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Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview
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Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log
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Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview
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Physician self-reported use of SC-PDA as measured by physician interview
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Physician opinion on perceived value and barriers to use as measured by physician interview
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Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Theodore W. Marcy, MD, MPH, University of Vermont
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- CDR0000629824
- VCC-08186
- IRB#00000486
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. .
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