Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention
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|ClinicalTrials.gov Identifier: NCT00384254|
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Cessation||Behavioral: 5 A Behavioral: 3 A||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||January 2008|
No Intervention: 1
Usual Care Control: Patients receive treatment as usual
"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.
"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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384254
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39213|
|Principal Investigator:||Judith S. Gordon, Ph.D||Oregon Research Institute|