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

NCT02564653 | Completed

• 1 other identifier: 14-01422
• Study Type: interventional
• Target: 4,733
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

• Adherence to tobacco use treatment guidelines and costs

  patient exit interviews

  Up to 12 months

Secondary Outcomes (1)

• Smoking abstinence

  Up to 12 months

Other Outcomes (1)

• Barriers and facilitators for tobacco use treatment

  Up to 12 months

Study Arms (2)

Technical Assistance, training,clinical reminders

OTHER

provider adherence to tobacco use treatment guidelines

Behavioral: Technical Assistance, training and clinical reminders

TTC + help of community health workers

OTHER

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.

Behavioral: TTC+Referral to Community Health Worker

Interventions

Technical Assistance, training and clinical reminders BEHAVIORAL

Technical Assistance, training and clinical reminders (TTC)

Technical Assistance, training,clinical reminders

TTC+Referral to Community Health Worker BEHAVIORAL

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

TTC + help of community health workers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient eligibility:
• Current patients at community health center for routine visit
• years or older
• Current or regular smoker (\>1 cigarette in past 7 days)
• Willingness to complete survey
• years or older
• Willingness to complete survey or interview

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 32907603 DERIVED

• 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.

  PMID: 28241770 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Donna Shelley, MD, MPH

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: October 1, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

US (1)