Tobacco Cessation Via Public Health Dental Clinics

Study Overview
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Brief Summary
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The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.

Detailed Description
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The prevalence of tobacco use is especially high in lower socioeconomic status (SES) populations in the U.S. Community Health Centers provide comprehensive primary care services, and usually dental services, to large numbers of low-income smokers and smokeless tobacco users. The typical patient has multiple dental visits, which can be used for tobacco cessation advice and counseling by the dental office team. This study builds on a successful pilot study conducted in two public health dental clinics. This study is a randomized clinical trial in which 14 public health dental clinics in Oregon, Mississippi, and New York City were stratified by state, matched within state by racial/ethnic composition, and then randomly assigned to either the Intervention or Usual Care Control condition. In the Intervention Condition, the dental team provided a brief intervention modeled on the 5A's advocated by the Clinical Practice Guideline.

Official Title
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Tobacco Cessation Via Public Health Dental Clinics (PHD2)

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Brief tobacco counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of participating public health dental clinics Tobacco users Exclusion Criteria: Emergency patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Dental practitioners provide the following intervention: 5As plus nicotine replacement therapy The 5As consist of: Ask, Advise, Assess, Assist and Arrange. | Behavioral: Brief tobacco counseling<br>* Public health dental professionals provide brief counseling during routine visits based on the Clinical Practice Guidelines 5 As (Ask, Advise, Assess, Assist, Arrange), including offering free Nicotine Replacement Therapy and referral to a Tobacco Quit Line. Pharmacologic: nicotine patch or lozenge maximum 12 week course.<br>|
| No Intervention: 1<br>Usual Care Control: Patients receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is prolonged abstinence at 7.5 months following intervention. |  | 7.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in tobacco use at 6 weeks and 7.5 months following intervention. |  | 6 weeks and 7.5 months | 
| Number of quit attempts at 6 weeks and 7.5 months following intervention. |  | 6 weeks & 7.5 months | 
| Increase in readiness to quit at 6 weeks & 7.5 months following intervention. |  | 6 weeks & 7.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Smoking, Smokeless, Cessation, Public health clinic, Dental patients, 5 As, NRT, Tobacco Quit Line, Smokeless tobacco