Tobacco Cessation Via Public Health Dental Clinics (PHD2)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tobacco Cessation Via Public Health Dental Clinics (PHD2)|
- The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
- Reduction in tobacco use at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks and 7.5 months ] [ Designated as safety issue: No ]
- Number of quit attempts at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ] [ Designated as safety issue: No ]
- Increase in readiness to quit at 6 weeks & 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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
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.
No Intervention: 1
Usual Care Control: Patients receive treatment as usual.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683839
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39213|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Oregon|
|Oregon Research Institute|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Judith S. Gordon, Ph.D||Oregon Research Institute|