Phone Enabled Implementation of Cessation Support

Not Applicable

Recruiting

• Conditions: Smoking Cessation
• Interventions: Behavioral: Educational materials; Behavioral: Provider training; Behavioral: Phone counseling; Behavioral: Electronic reminders; Drug: Nicotine Replacement Therapy

• Registration Number: NCT05628389
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Study Start: 2024-03-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2027-04-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ask-Advice-Assist (AAA)	Educational materials	All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
Ask-Advice-Assist (AAA)	Provider training	All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
Ask-Advice-Assist (AAA)	Electronic reminders	All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
Ask-Advise-Connect (AAC)	Provider training	Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
Ask-Advise-Connect (AAC)	Electronic reminders	Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)	Phone counseling	In addition to AAC, patients will be offered NRT.
Ask-Advise-Connect (AAC)	Phone counseling	Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)	Electronic reminders	In addition to AAC, patients will be offered NRT.
Ask-Advise-Connect (AAC)	Educational materials	Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)	Provider training	In addition to AAC, patients will be offered NRT.
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)	Educational materials	In addition to AAC, patients will be offered NRT.
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)	Nicotine Replacement Therapy	In addition to AAC, patients will be offered NRT.

Primary Outcome Measures

Name	Time	Method
7-day smoking abstinence	6 Months	Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon