Tobacco Use Cessation Clinical Trial
Vietnam has a smoking prevalence that is the second highest among South East Asian countries (SEACs). With a population of approximately 90 million, Vietnam also has the second largest total number of adult smokers (over 16 million) in SEA. According to the World Health Organization (WHO), most reductions in mortality from tobacco use in the near future will be achieved through helping current users quit. Tobacco use treatment, as defined by the U.S. Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of recommended care is suboptimal. The objective of this proposal is to fill the current research-to-practice gap by conducting a randomized controlled trial that compares the effectiveness and cost effectiveness of two practical and highly replicable strategies for implementing evidence-based guidelines for the treatment of tobacco use in public health clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches, and the WHO's recently released guidelines for implementing Article 14 of the Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the need to integrate best practices for treating tobacco use and dependence into routine preventive care. The proposed implementation strategies also build on the growing literature that supports the effectiveness of integrating community health workers as members of the health care team to improve access to preventive services.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patient eligibility: - Current patients at community health center for routine visit - 18 years or older - Current or regular smoker (>1 cigarette in past 7 days) - Willingness to complete survey - Provider eligibility: - Provider at community health center - 18 years or older - Willingness to complete survey or interview |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | Institute of Social and Medical Studies | Hanoi |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to tobacco use treatment guidelines | To assess the primary outcome of provider adherence to tobacco treatment guidelines, the investigators will conduct patient exit interviews (PEI) (surveys conducted immediately after the patient visit) with 50 smokers pre and 50 postimplementation at each site (1300 in each study period). | 4-6 weeks | No |
Secondary | Smoking abstinence | Using accepted standards for measuring cessation outcomes, all patients who complete a PEI in the post intervention period will be followed prospectively to assess 3 and 6 month 7-day point prevalence abstinence, defined as any smoking (even a puff) in the past 7 days. Surveys will be conducted in person and smoking abstinence will be validated using carbon monoxide (CO) monitoring with abstinence defined as a CO<10ppm. | 6 months | No |
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