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

NCT ID: NCT02564653

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4733 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-08-31

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.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technical Assistance, training,clinical reminders

provider adherence to tobacco use treatment guidelines

Group Type: OTHER

Technical Assistance, training and clinical reminders

Intervention Type: BEHAVIORAL

Technical Assistance, training and clinical reminders (TTC)

TTC + help of community health workers

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.

Group Type: OTHER

TTC+Referral to Community Health Worker

Intervention Type: BEHAVIORAL

TTC+ referral to a VHW for additional counseling and follow-up

Interventions

Technical Assistance, training and clinical reminders

Technical Assistance, training and clinical reminders (TTC)

Intervention Type: BEHAVIORAL

TTC+Referral to Community Health Worker

TTC+ referral to a VHW for additional counseling and follow-up

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Shelley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

References

VanDevanter N, Vu M, Nguyen A, Nguyen T, Van Minh H, Nguyen NT, Shelley DR. A qualitative assessment of factors influencing implementation and sustainability of evidence-based tobacco use treatment in Vietnam health centers. Implement Sci. 2020 Sep 9;15(1):73. doi: 10.1186/s13012-020-01035-6.

Reference Type: DERIVED

PMID: 32907603 (View on PubMed)

VanDevanter N, Kumar P, Nguyen N, Nguyen L, Nguyen T, Stillman F, Weiner B, Shelley D. Application of the Consolidated Framework for Implementation Research to assess factors that may influence implementation of tobacco use treatment guidelines in the Viet Nam public health care delivery system. Implement Sci. 2017 Feb 28;12(1):27. doi: 10.1186/s13012-017-0558-z.

Reference Type: DERIVED

PMID: 28241770 (View on PubMed)

Other Identifiers

14-01422

Identifier Type: -

Identifier Source: org_study_id