Implementing Tobacco Use Guidelines in Community Health Centers in Vietnam Public Health System
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ClinicalTrials.gov Identifier: NCT02564653 |
Recruitment Status :
Completed
First Posted : October 1, 2015
Last Update Posted : June 1, 2020
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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 |
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
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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.
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Behavioral: TTC+Referral to Community Health Worker
TTC+ referral to a VHW for additional counseling and follow-up |
- Adherence to tobacco use treatment guidelines and costs [ Time Frame: Up to 12 months ]patient exit interviews
- 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
- 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

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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 |
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

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
United States, New York | |
NYU Langone Medical Center | |
New York, New York, United States, 10016 |
Principal Investigator: | Donna Shelley, MD, MPH | NYU School of Medicine |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |