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3A-OR Very Brief Tobacco Cessation Intervention in Primary Care

21 de mayo de 2026 actualizado por: Melda Dibek, Aydin Adnan Menderes University

The Effectiveness of the 3A-OR Very Brief Tobacco Cessation Intervention in Primary Care: A Multicenter Pragmatic Trial Protocol

Introduction: Türkiye is far from the World Health Organization (WHO)'s target of reducing tobacco use prevalence by 30% by 2025. Most tobacco users consider quitting, and most have attempted to quit at least once. However, the success rate of quitting on one's own is quite low. Studies demonstrating that very brief tobacco cessation interventions delivered by healthcare professionals increase cessation rates have almost entirely been conducted in hospital settings. The aim of this trial is to investigate the effectiveness of implementing the 3A-OR (Ask - Assess - Advise - Offer Assistance - Record) very brief tobacco cessation intervention in routine primary care family medicine practice on the success of tobacco cessation.

Methods/design: This protocol describes a two-arm, multicenter pragmatic trial for adolescent and adult tobacco users. The project will be carried out in family health centers in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention to their patients as part of their routine clinical practice. The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'. Routine practice in family health centers will constitute the control group. Data will be collected using standard questionnaire forms at baseline and during follow-up interviews at 3, 6, and 12 months. Tobacco cessation rate and increase in smokers' motivation were the primary outcomes of the trial.

Discussion: If the 3A-OR very brief tobacco cessation intervention is found to be effective, the results of this trial will provide evidence that will encourage the widespread use of the intervention in primary care family health centers. The study results are intended to be disseminated through the Family Medicine Academy Association website, conference presentations, and scientific publications.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

3A-OR Model (Ask - Assess - Advise - Offer Assistance - Record) In this brief intervention algorithm, the physician primarily learns every patient's smoking status, assesses the smoker's motivation to quit, advises cessation with different approaches for the pre-contemplation and contemplation/preparation stages, then offers assistance, and finally records the encounter in the patient's file. Its motivational impact is reported to be higher than the other comparable models. The Turkish abbreviation is 3Ö-TK.

Theoretical Framework

  1. (A) LEARN!

    During visits the patient may share information about smoking. If not, the physician inquires within the routine assessment of habits:

    "Do you smoke cigarettes?" Smokers are briefly informed about the study and invited to participate; only those who consent proceed to the next steps.

  2. (A) ASSESS!

    The physician evaluates the smoker's motivation to quit:

    "Are you considering quitting smoking?" The smoker may be in the pre-contemplation, contemplation or preparation stage.

    If the smoker is in the PRE-CONTEMPLATION stage:

  3. (A) ADVISE! "Smoking is harmful to health. It causes cardiovascular disease, COPD, cancer and many other conditions. One out of every two lifelong smokers dies from a smoking-related cause. Quitting is the single most important action you can take for your health. I strongly advise you to stop smoking."
  4. (O) OFFER ASSISTANCE! "If you would like to talk about smoking, I can schedule a separate appointment for you (if the smoker agrees, the earliest possible slot is arranged). Should you consider quitting at any point, I am always available to help personally or to refer you to a smoking-cessation clinic." A brochure containing information on smoking and local cessation services is handed to the patient.
  5. (R) RECORD! The family physician documents the patient's smoking status and advice given. At every subsequent contact, the topic is revisited from where it left off, and the intervention is repeated.

If the smoker is in the CONTEMPLATION or PREPARATION stage 3. (A) ADVISE! "I commend you on your intention to quit smoking. Smoking is harmful to health and one in two smokers dies from a smoking-related cause. Quitting is the most important step you can take for your wellbeing. I encourage you to implement your plan as soon as possible." 4. (O) OFFER ASSISTANCE! "I can assist you throughout this process. If you wish, we can schedule a dedicated appointment. You may also seek support from a smoking-cessation clinic (hand the patient a brochure listing clinic details). Whenever you are ready, I can arrange an appointment for you." 5. (R) RECORD! The family physician records all smoking-related information. At each follow-up visit, the discussion continues from the previous point and the intervention is repeated.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

2400

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

Copia de seguridad de contactos de estudio

  • Nombre: Okay Başak, MD
  • Número de teléfono: +905333375579
  • Correo electrónico: okaybasak@yahoo.com

Ubicaciones de estudio

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Being aged 15 years and older (including pregnant and breastfeeding women);
  2. Having used any tobacco product at least once daily within the last month;
  3. All smokers, regardless of their intention to quit tobacco use;
  4. Providing a phone number for follow-up;
  5. Being able to read and speak Turkish;
  6. Signing the informed consent form.

Exclusion Criteria:

  1. Using tobacco products less than once per day;
  2. Having made an attempt to quit tobacco use within the last month;
  3. Having impaired cognitive functions;
  4. Having participated in another study on tobacco use within the past year.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Study Group
participants who used tobacco products and underwent the intervention
The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'.
Sin intervención: Control Group
Participants who use tobacco products but were not subjected to the intervention, usual care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Smoking cessation success
Periodo de tiempo: At 3, 6 and 12-month follow ups
Patient-reported success in quitting tobacco use among smokers in the intervention and control groups at the end of three, six, and twelve months
At 3, 6 and 12-month follow ups

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motivational change
Periodo de tiempo: At 3, 6 and 12-month follow ups
Changes in motivation to quit among smokers who have not quit tobacco use. For successful tobacco cessation, the key criterion will be that the individual has not used tobacco for at least the last 7 days at the three-month follow-up, at least the last 15 days at the six-month follow-up, and at least the last month at the one-year follow-up
At 3, 6 and 12-month follow ups

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Melda Dibek, MD, Adnan Menders University

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 (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de julio de 2026

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Melda DİBEK

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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