Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam

NCT01967654 | Withdrawn

• 1 other identifier: 13-00413
• Study Type: interventional
• Target: N/A
• 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

  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

Secondary Outcomes (1)

• Smoking abstinence

  6 months

Study Arms (2)

Technical assistance, training, plus clinical reminder system

EXPERIMENTAL

To assess the contextual factors of the intervention settings (district level policies and organizational level characteristics) that may influence tobacco use treatment in CHCs and to inform additional modifications to the proposed implementation strategies.

Other: Technical Assistance, training and clinical reminders

TTC + referral to community health workers

EXPERIMENTAL

To compare the effectiveness and cost effectiveness of two multi component implementation strategies.

Other: Referral to Community Health Worker

Interventions

Technical Assistance, training and clinical reminders OTHER

Technical assistance, training, plus clinical reminder system

Referral to Community Health Worker OTHER

TTC + referral to 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
• Provider eligibility:
• Provider at community health center
• years or older
• Willingness to complete survey or interview

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Institute of Social and Medical Studies

Hanoi, Vietnam

Location

Related Publications (2)

• Shelley D, Cleland CM, Nguyen T, VanDevanter N, Siman N, Van Minh H, Nguyen N. Effectiveness of a Multicomponent Strategy for Implementing Guidelines for Treating Tobacco Use in Vietnam Commune Health Centers. Nicotine Tob Res. 2022 Feb 1;24(2):196-203. doi: 10.1093/ntr/ntab189.

  PMID: 34543422 DERIVED

• Shelley D, VanDevanter N, Cleland CC, Nguyen L, Nguyen N. Implementing tobacco use treatment guidelines in community health centers in Vietnam. Implement Sci. 2015 Oct 9;10:142. doi: 10.1186/s13012-015-0328-8.

  PMID: 26453554 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: October 18, 2013
• First Posted: October 23, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

VN (1)