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

Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System:a Rural Model

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Technical Assistance, training and clinical reminders; Behavioral: TTC+Referral to Community Health Worker

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.

• Study Type: Interventional
• Enrollment (Actual): 4733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Technical Assistance, training,clinical reminders; provider adherence to tobacco use treatment guidelines	Behavioral: Technical Assistance, training and clinical reminders; Technical Assistance, training and clinical reminders (TTC)
Other: 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.	Behavioral: TTC+Referral to Community Health Worker; TTC+ referral to a VHW for additional counseling and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to tobacco use treatment guidelines and costs	patient exit interviews	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking abstinence	Surveys will be conducted in person and smoking abstinence will be validated using carbon monoxide (CO) monitoring	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers and facilitators for tobacco use treatment	practice environment checklist to inventory current policies, work flow, systems (e.g. chart systems) and staff roles and responsibilities in general and specifically related to tobacco use treatment	Up to 12 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Donna Shelley, MD, MPH, NYU School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 14-01422

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No