Phone Enabled Implementation of Cessation Support

Обзор

The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.

Подробное описание

The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.

Вмешательства

• Поведенческое Educational materials
  Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.
• Поведенческое Phone counseling
  Cessation counseling to address insufficient patient self-efficacy and motivation.
• Препарат Nicotine Replacement Therapy
  Nicotine patches to address nicotine withdrawal symptoms in patients.
• Поведенческое Provider training
  Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.
• Поведенческое Electronic reminders
  Electronic reminders to address the lack of integration of AAA/AAC into practice.

Первичные конечные точки

• 7-day smoking abstinence [Срок оценки: 6 Months]

Критерии участия

Критерии включения

• Age 18+
• A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week).
• Not pregnant
• Reachable by phone
• Interested in quitting
• Lives in Greater Beirut Area

Критерии исключения

• Patients who use other tobacco products including vape exclusively.
• Any patient below 18 years old.
• Cigarette smokers who do not smoke on daily basis.
• Waterpipe smokers who smoke less than once/weekly

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Ливан · 1 центр

• American University of Beirut Medical Center — Beirut

Публикации

• Salloum RG, Romani M, Bteddini DS, El-Jardali F, Lee JH, Theis R, LeLaurin JH, Hamadeh R, Osman M, Abla R, Khaywa J, Ward KD, Shelley D, Nakkash R. An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS. Implement Sci Commun. 2023 Jun 26;4(1):72. doi: 10.1186/s43058-023-00456-w. PMID 37365656

Идентификаторы

NCT: NCT05628389 · IRB202202537 -N · R01CA262319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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