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Completed

NCT Number: NCT00384254

Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5 A

Behavioral

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.

3 A

Behavioral

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.

Primary outcomes

  1. The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.

    Time frame: 3 and 12 month

  2. 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 outcomes

  1. Conduct an economic analysis to determine the incremental cost per quit of the two interventions.

    Time frame: 12 month

  2. Examine predictors of patient outcomes and the interaction of these variables with intervention condition.

    Time frame: 12 month

  3. Examine patients' report of practitioner protocol delivery at six weeks as a function of intervention condition.

    Time frame: 6 week and 12 month

  4. Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions.

    Time frame: 12 month

  5. Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol.

    Time frame: 3 and 12 month

  6. 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

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Oct 6, 2006
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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