Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System

Not Applicable

Completed

• Conditions: Tobacco Use Cessation
• Interventions: Behavioral: Technical Assistance, training and clinical reminders; Behavioral: TTC+Referral to Community Health Worker

• Registration Number: NCT02564653
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

The long-term goal of the project is to develop a generalizable model for implementing evidence-based tobacco use treatment within existing health systems locally and globally. 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 of two practical and highly replicable strategies for implementing evidence-based guidelines for the treatment of tobacco use in public health clinics and community based settings 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 Article 14specifies the need to integrate clinical 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4733

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
• 18 years or older
• Willingness to complete survey or interview

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technical Assistance, training,clinical reminders	Technical Assistance, training and clinical reminders	provider adherence to tobacco use treatment guidelines
TTC + help of community health workers	TTC+Referral to Community Health Worker	We will assess this secondary aim by comparing smoking cessation outcomes among smokers who receive brief provider counseling alone only vs. smokers who receive provider counseling + community health worker counseling. The purpose of this assessment is to specifically analyze the impact of the community health worker counseling component of the intervention using a quasiexperimental design that leverages the larger RCT.

Primary Outcome Measures

Name	Time	Method
Adherence to tobacco use treatment guidelines and costs	Up to 12 months	patient exit interviews

Secondary Outcome Measures

Name	Time	Method
Smoking abstinence	Up to 12 months	Surveys will be conducted in person and smoking abstinence will be validated using carbon monoxide (CO) monitoring

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States