Tobacco Cessation Via Public Health Dental Clinics

Smoking Clinical Trial

— PHD2  

Official title:

Tobacco Cessation Via Public Health Dental Clinics (PHD2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683839
• Other study ID #: 5R01CA107442-3
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: October 24, 2011
• Start date: January 2006
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2637
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of participating public health dental clinics

• Tobacco users

Exclusion Criteria:

• Emergency patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of Mississippi	Jackson	Mississippi
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Research Institute	Columbia University, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gordon JS, Andrews JA, Albert DA, Crews KM, Payne TJ, Severson HH. Tobacco cessation via public dental clinics: results of a randomized trial. Am J Public Health. 2010 Jul;100(7):1307-12. doi: 10.2105/AJPH.2009.181214. Epub 2010 May 13. — View Citation

Hinds E, Gordon JS, Widdop CJ. Tobacco Cessation in Public Health Dental Clinics: Short-Term Outcomes for Women. Society of Behavioral Medicine's 29th Annual Meeting and Scientific Sessions in San Diego, California, March 26-29th, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is prolonged abstinence at 7.5 months following intervention.		7.5 months	No
Secondary	Reduction in tobacco use at 6 weeks and 7.5 months following intervention.		6 weeks and 7.5 months	No
Secondary	Number of quit attempts at 6 weeks and 7.5 months following intervention.		6 weeks & 7.5 months	No
Secondary	Increase in readiness to quit at 6 weeks & 7.5 months following intervention.		6 weeks & 7.5 months	No