This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00384254
First received: October 3, 2006
Last updated: October 24, 2011
Last verified: October 2011
  Purpose
The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research—dental office interventions and telephone help line effectiveness—led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.

Condition Intervention Phase
Tobacco Use Cessation Behavioral: 5 A Behavioral: 3 A Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention. [ Time Frame: 3 and 12 month ]
  • Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit. [ Time Frame: 3 and 12 months ]

Secondary Outcome Measures:
  • Conduct an economic analysis to determine the incremental cost per quit of the two interventions. [ Time Frame: 12 month ]
  • Examine predictors of patient outcomes and the interaction of these variables with intervention condition. [ Time Frame: 12 month ]
  • Examine patients' report of practitioner protocol delivery at six weeks as a function of intervention condition. [ Time Frame: 6 week and 12 month ]
  • Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions. [ Time Frame: 12 month ]
  • Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol. [ Time Frame: 3 and 12 month ]
  • Assess the effect of the intervention condition on changes in self-reported attitudes of dentists, dental hygienists, and dental assistants. [ Time Frame: 3 and 12 month ]

Enrollment: 2177
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual Care Control: Patients receive treatment as usual
Experimental: 2
"5 A" Intervention Condition: Patients in this condition receive all five "A" components (Ask, Advise, Assess, Assist, Arrange) recommended in the Clinical Practice Guideline: Treating Tobacco Use and Dependence.
Behavioral: 5 A
Dental providers are trained to provide Ask, Advise, Assess, Assist and Arrange to all tobacco using patients. Written materials are provided, including information on local cessation resources, pharmacotherapy and tobacco quitlines.
Experimental: 3
"3 A" Condition: Patients receive Ask, Advise, Arrange intervention consisting of the first two "A" components recommended by the Clinical Practice Guideline: Treating tobacco Use and Dependence, plus Fax-to-Quit referral to a tobacco quit line.
Behavioral: 3 A
Providers are trained to provide Ask, Advise and Arrange intervention to all tobacco using patients. Written materials, prescription for NRT and a Fax-to-Quit referral are provided.

Detailed Description:

Although many dental practitioners now routinely incorporate the first two of the "5A's" (Ask and Advise) into their practice, and previous research indicates that brief office-based interventions are effective in producing modest tobacco quit rates for dental patients, dental practitioners continue to perceive a number of obstacles to routine provision of tobacco cessation services. Many dental practitioners still believe that counseling patients to quit an addictive behavior is beyond the scope of their training or comfort.

Recent studies have shown that proactive phone counseling from State-sponsored telephone tobacco help lines has a positive effect on tobacco cessation. The use of these help lines offers a unique supplement to the dental professional that could reduce the burden on practitioner and enhance the likelihood of their patients' quitting. Referral to a specialist is within the common heuristic followed by dental and medical practitioners. Therefore, we believe referral to a telephone help line may be an innovative way of enabling dentists and dental hygienists to encourage and support their patients to quit tobacco.

We will test two levels of intervention as compared to usual care in a randomized clinical trial in which 60 dental practices in Mississippi are randomized to one of three conditions. In one condition ("5A's"), the dental team will provide a brief office-based intervention that is modeled on the "5A's" advocated by the Clinical Practice Guideline. In the second condition ("3A's" + THL), the dental team will provide the first three "A's" (Ask, Advise, Assess), and then refer patients to the State-supported telephone help line for provision of the cessation counseling and follow-up support. In the third condition (Usual Care), volunteering practices will ask their patients only to complete our study surveys.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
  • Dentists in private practice, employing at least one dental hygienist and one dental assistant.

Exclusion Criteria:

  • Dental patients under the age of 18
  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: NCT00384254

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39213
Sponsors and Collaborators
Oregon Research Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Judith S. Gordon, Ph.D Oregon Research Institute
  More Information

Publications:
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00384254     History of Changes
Other Study ID Numbers: DA 17972
R01DA017972 ( U.S. NIH Grant/Contract )
Study First Received: October 3, 2006
Last Updated: October 24, 2011

Keywords provided by Oregon Research Institute:
Tobacco.
Cessation.
Dental patients.
Dentists.
Hygienists.
Dental assistants.
Health care providers.
Behavioral intervention.
Tobacco intervention.
Cigarettes.
Smokeless tobacco.
Smoking intervention.

ClinicalTrials.gov processed this record on September 21, 2017