Phone Enabled Implementation of Cessation Support (PHOENICS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phone Enabled Implementation of Cessation Support (PHOENICS)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Educational materials
* Behavioral: Phone counseling
* Drug: Nicotine Replacement Therapy
* Behavioral: Provider training
* Behavioral: Electronic reminders


Participation Criteria
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Eligibility Criteria
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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 smoke other tobacco products including vape, IQOS and others exclusively. Any patient below 18 years old. Cigarette smokers who do not smoke on daily basis. Waterpipe smokers who smoke less than once/weekly

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ask-Advice-Assist (AAA)<br>All patients will be screened for tobacco use, and offer brief cessation advice and counseling. | Behavioral: Educational materials<br>* Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.<br>Behavioral: Provider training<br>* Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.<br>Behavioral: Electronic reminders<br>* Electronic reminders to address the lack of integration of AAA/AAC into practice.<br>|
| Experimental: Ask-Advise-Connect (AAC)<br>Patients in will be connected to phone counseling and will receive six sessions of telephone counseling. | Behavioral: Educational materials<br>* Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.<br>Behavioral: Phone counseling<br>* Cessation counseling to address insufficient patient self-efficacy and motivation.<br>Behavioral: Provider training<br>* Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.<br>Behavioral: Electronic reminders<br>* Electronic reminders to address the lack of integration of AAA/AAC into practice.<br>|
| Experimental: Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)<br>In addition to AAC, patients will be offered NRT. | Behavioral: Educational materials<br>* Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.<br>Behavioral: Phone counseling<br>* Cessation counseling to address insufficient patient self-efficacy and motivation.<br>Drug: Nicotine Replacement Therapy<br>* Nicotine patches to address nicotine withdrawal symptoms in patients.<br>Behavioral: Provider training<br>* Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.<br>Behavioral: Electronic reminders<br>* Electronic reminders to address the lack of integration of AAA/AAC into practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day smoking abstinence | Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment | 6 Months |