NCT05628389

Phone Enabled Implementation of Cessation Support

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation

Interventions

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

Timeline

• Start date: 2024-03-06
• Primary completion: 2027-08-30
• Completion: 2027-08-31
• First posted: 2022-11-28
• Last updated: 2025-07-01

Locations

1 site across 1 country: Lebanon