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Trial details
Phone Enabled Implementation of Cessation Support
Current status:
Approved
|
Date registered:
20/03/2023
Trial version(s)
Current: 21/11/2022
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Main Information
Primary registry identifying number
LBCTR2023015204
Protocol number
NCT05628389
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
15/11/2023
Primary sponsor
University of Florida
Primary sponsor: Country of origin
United States
Public title
Phone Enabled Implementation of Cessation Support
Acronym
PHOENICS
Scientific title
Phone Enabled Implementation of Cessation Support
Acronym
PHOENICS
Brief summary of the study: English
The tobacco use burden in Lebanon is exceptionally high. 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. 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.
Brief summary of the study: Arabic
إنّ عبء استخدام التبغ في لبنان مرتفع بشكل استثنائي. على الرغم أنّ منظّمة الصحة العالمية توصي بالتدخّلات القائمة على الأدلة بهدف علاج الاعتماد على التبغ على المستوى السكاني، لم يتم دمج هذه العلاجات كجزء روتيني من الرعاية الأولية في لبنان، كما هو الحال في بلدان أخرى ذات موارد محدودة. تهدف هذه الدراسة الى تقييم فعالية تدخلات قائمة على الأدلة لتنفيذ علاج الإقلاع عن التدخين في مراكز الرعاية الصحية الأولية في لبنان. سيتم السعي لتحقيق الأهداف المحددة التالية: 1) تعديل برنامج الإقلاع عن التدخين الحالي لتقديم الاستشارة عبر الهاتف للمدخنين في لبنان. 2) اختبار فعالية وتكلفة برنامج قائم على الإحالة يقدم خدمات الإقلاع عن التدخين لمرضى مراكز الرعاية الأولية ؛ 3) تحديد العوامل - متعددة المستويات - التي تؤثر على التنفيذ والاستدامة.
Health conditions/problem studied: Specify
Smoking. We will include exclusive cigarette, exclusive waterpipe and dual cigarette/waterpipe smokers.
Interventions: Specify
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 NRT is the most effective alternative.
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria: - age ≥18 years - patient at a participating primary health care center with a visit in the past 6 months - daily smoker (≥ 5 cigarettes or ≥1 waterpipe session per day) - reachable by phone - interested in quitting - lives in Greater Beirut - able to provide informed consent
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
- pregnant or nursing patients - patients for whom NRT is medically contraindicated - patients enrolled in other tobacco treatment programs
Type of Study
Type
Interventional
Type of intervention
Behavioral treatment
Trial scope
Other
Trial scope: Specify scope
Smoking cessation
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Single
Pharmaceutical class
N/A
Therapeutic indication
N/A
Therapeutic benefit
NRT will promote successful smoking abstinence by addressing nicotine withdrawal symptoms.
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
1500
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/10/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
30/06/2026
Recruitment status
Pending
Date of completion
01/09/2027
IPD sharing statement plan
Yes
IPD sharing statement description
We consider sharing of data and resources generated by this project to be an essential component of our proposed activities. We will make our results available to the community of scientists interested in interventions for tobacco dependence treatment in low-resource settings. This has the purpose both of sharing science and avoiding unintentional duplication of research. As we establish a large dataset of clinical trial and implementation measures and outcomes, we anticipate that the data will become a resource to researchers with an interest in tobacco control, global health, primary care, and implementation science. Although we intend to allow investigators who are associated with the study to have priority for analyzing questions of interest to them, we will make the data available in compliance with relevant guidelines and compliance with consent forms, IRB approvals, as well as University of Florida (UF) and American University of Beirut (AUB) regulations. Before making data available to others outside this project, we will ensure that the data to be shared are de-identified or provided in a Limited Dataset and comply with both IRB regulations and the Privacy Rule under HIPAA regulations. No protected health information, including personally identifiable information (PHI) such as name, address, telephone, or other identifying information will be shared outside of UF and AUB except when needed for study purposes, and only after IRB approval. We will invite other investigators not associated with the study to propose ancillary studies that will of necessity require sharing of data that we have collected or that come from UF and AUB, because we view this study as an important resource for building evidence for the implementation of evidence-based tobacco treatment interventions in low-resource settings. Any such requests from non-study investigators will be reviewed by the principal investigators and co-investigators to ensure they do not conflict with planned analyses, conserve resources, are respectful of study participants, and comply with relevant IRB and HIPAA regulations. We will make study data available to other investigators under data use agreements between the data collection site and data recipient site(s). These agreements will ensure that the data will be used only for specified research purposes, that any individual participant’s data will not be disseminated beyond the data recipient, that the data will not be used to identify an individual participant, that data will be protected under appropriate data security measures including encryption and password protection, and that the data will be destroyed or returned to us upon completion of relevant analyses. Furthermore, we will also determine whether at least one member of our investigator team should be involved scientifically in any projects that result from data sharing requests. We also plan to present findings at scientific conferences and through publications. We will share results and products (e.g., patient education materials) with community members, NGOs, and governmental organizations in Lebanon through a variety of forums tailored to each target population, including through the Knowledge to Policy Center at AUB.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
National Institutes of Health - Department of Health and Human Services
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ruba
Abla
AUB
Lebanon
01-350000
ra328@aub.edu.lb
AUB
Scientific
Maya
Romani
AUB
Lebanon
01-350000
mr39@aub.edu.lb
AUB - MC
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
AUB-MC
Maya Romani
Practicing family physician, clinical educator, researcher and Director of the AUB Smoking Cessation Program
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
26/01/2023
Lina El-Onsi Daouk
le08@aub.edu.lb
T +961 1 35 00 00 – Ext 5445
Other
University of Florida
26/08/2022
Peter Iafrate,
irb@ufl.edu
(352) 273−9600
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Ask-Advice-Assist
All patients will be screened for tobacco use, and offer brief cessation advice and counseling
AAA
Ask-Advise-Connect
Patients will be connected to phone counseling and will receive six sessions of telephone counseling
AAC
Ask-Advise-Connect + Nicotine Replacement Therapy
In addition to AAC, patients will be offered NRT.
AAC+NRT
Primary Outcomes
Name
Time points
Measure
Smoking abstinence
6-month
Carbon monoxide confirmed-abstinence from smoking in the last 7 days prior to assessment
Key Secondary Outcomes
Name
Time points
Measure
Continuous abstinence
1, 3, and 6 months
Self-reported measure
24-hour quit attempts
1, 3, and 6 months
Self-reported measure
Reduction in smoking
1, 3, and 6 months
Self-reported measure
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
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