- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07609199
3A-OR Very Brief Tobacco Cessation Intervention in Primary Care
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
(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.
(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:
- (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."
- (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.
- (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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Melda Dibek, MD
- Telefonní číslo: +905305793069
- E-mail: mdbuyukdinc@adu.edu.tr
Studijní záloha kontaktů
- Jméno: Okay Başak, MD
- Telefonní číslo: +905333375579
- E-mail: okaybasak@yahoo.com
Studijní místa
-
-
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Aydin, Turecko (Türkiye)
- Family Health Centers
-
Kontakt:
- Melda Dibek, MD
- Telefonní číslo: +905305793069
- E-mail: mdbuyukdinc@adu.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being aged 15 years and older (including pregnant and breastfeeding women);
- Having used any tobacco product at least once daily within the last month;
- All smokers, regardless of their intention to quit tobacco use;
- Providing a phone number for follow-up;
- Being able to read and speak Turkish;
- Signing the informed consent form.
Exclusion Criteria:
- Using tobacco products less than once per day;
- Having made an attempt to quit tobacco use within the last month;
- Having impaired cognitive functions;
- Having participated in another study on tobacco use within the past year.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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'.
|
|
Žádný zásah: Control Group
Participants who use tobacco products but were not subjected to the intervention, usual care
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Smoking cessation success
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Motivational change
Časové okno: 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
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At 3, 6 and 12-month follow ups
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Melda Dibek, MD, Adnan Menders University
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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