Tobacco Cessation Via Public Health Dental Clinics (PHD2)

This study has been completed.

Sponsor:

Collaborators:

Columbia University

University of Mississippi Medical Center

Information provided by (Responsible Party):

Oregon Research Institute

ClinicalTrials.gov Identifier:

NCT00683839

First received: May 16, 2008

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention	Phase
Smoking	Behavioral: Brief tobacco counseling	Phase 2


Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Smoking

U.S. FDA Resources

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:

The primary outcome is prolonged abstinence at 7.5 months following intervention. [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	2637
Study Start Date:	January 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients of participating public health dental clinics
Tobacco users

Exclusion Criteria:

Emergency patients

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683839

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

Publications:

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.

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
Study First Received:	May 16, 2008
Last Updated:	October 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Research Institute:


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

ClinicalTrials.gov processed this record on March 03, 2015

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