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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02564653
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Technical Assistance, training and clinical reminders Behavioral: TTC+Referral to Community Health Worker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4733 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System:a Rural Model
Actual Study Start Date : August 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Arm Intervention/treatment
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)

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




Primary Outcome Measures :
  1. Adherence to tobacco use treatment guidelines and costs [ Time Frame: Up to 12 months ]
    patient exit interviews


Secondary Outcome Measures :
  1. Smoking abstinence [ Time Frame: Up to 12 months ]
    Surveys will be conducted in person and smoking abstinence will be validated using carbon monoxide (CO) monitoring


Other Outcome Measures:
  1. Barriers and facilitators for tobacco use treatment [ Time Frame: Up to 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564653


Locations
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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Donna Shelley, MD, MPH NYU School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02564653    
Other Study ID Numbers: 14-01422
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No