Tobacco Cessation Via Public Health Dental Clinics (PHD2)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Smoking	Behavioral: Brief tobacco counseling	Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2637 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Tobacco Cessation Via Public Health Dental Clinics (PHD2)
Study Start Date :	January 2006
Actual Primary Completion Date :	September 2009
Actual Study Completion Date :	September 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 2; 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.

Outcome Measures

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Primary Outcome Measures :

1. The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ]

Secondary Outcome Measures :

1. Reduction in tobacco use at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks and 7.5 months ]
2. Number of quit attempts at 6 weeks and 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ]
3. Increase in readiness to quit at 6 weeks & 7.5 months following intervention. [ Time Frame: 6 weeks & 7.5 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Patients of participating public health dental clinics
• Tobacco users

Exclusion Criteria:

• Emergency patients

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39213
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403

Sponsors and Collaborators

Oregon Research Institute

Columbia University

University of Mississippi Medical Center

Investigators

Principal Investigator:	Judith S. Gordon, Ph.D	Oregon Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Other Publications:

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.

Responsible Party:	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00683839 History of Changes
Other Study ID Numbers:	5R01CA107442-3; 5R01CA107442 ( U.S. NIH Grant/Contract )
First Posted:	May 26, 2008
Last Update Posted:	October 26, 2011
Last Verified:	October 2011

Keywords provided by Oregon Research Institute:

Tobacco; Smoking; Smokeless; Cessation; Public health clinic	Dental patients; 5 As; NRT; Tobacco Quit Line; Smokeless tobacco