Phone Enabled Implementation of Cessation Support (PHOENICS)

University of Florida

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Behavioral: Phone counseling; Behavioral: Educational materials; Drug: Nicotine Replacement Therapy; Behavioral: Electronic reminders; Behavioral: Provider training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05628389

IRB202202537 -N

R01CA262319 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Ask-Advice-Assist (AAA)

Other group

Description:

All patients will be screened for tobacco use, and offer brief cessation advice and counseling.

Treatment:

Behavioral: Provider training

Behavioral: Electronic reminders

Behavioral: Educational materials

Ask-Advise-Connect (AAC)

Experimental group

Description:

Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.

Treatment:

Behavioral: Provider training

Behavioral: Electronic reminders

Behavioral: Phone counseling

Behavioral: Educational materials

Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)

Experimental group

Description:

In addition to AAC, patients will be offered NRT.

Treatment:

Behavioral: Provider training

Behavioral: Electronic reminders

Drug: Nicotine Replacement Therapy

Behavioral: Phone counseling

Behavioral: Educational materials