Tobacco Use CessationPhase 2NCT00384254
Tobacco Quitlines:Adjunct to Dental Office Tobacco Intervention
A Phase 2 study testing 5 A and 3 A in people with Tobacco Use Cessation, run by Oregon Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- 5 A and 3 A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,177 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dental patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39213
About this study
Official title: Tobacco Quitlines as an 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.
Read the 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.
- Conditions
- Tobacco Use Cessation
- Being tested
- 5 A, 3 A
- Keywords
- Tobacco., Cessation., Dental patients., Dentists., Hygienists., Dental assistants., Health care providers., Behavioral intervention., Tobacco intervention., Cigarettes., Smokeless tobacco., Smoking intervention.
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 ABehavioural
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 ABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Care Control: Patients receive treatment as usual |
| 2 | Experimental | "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. Receives: Behavioral: 5 A |
| 3 | Experimental | "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. Receives: Behavioral: 3 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.
Measured: 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.
Measured: 3 and 12 months
Secondary outcomes (6)
Conduct an economic analysis to determine the incremental cost per quit of the two interventions.
Measured: 12 month
Examine predictors of patient outcomes and the interaction of these variables with intervention condition.
Measured: 12 month
Examine patients' report of practitioner protocol delivery at six weeks as a function of intervention condition.
Measured: 6 week and 12 month
Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions.
Measured: 12 month
Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol.
Measured: 3 and 12 month
Assess the effect of the intervention condition on changes in self-reported attitudes of dentists, dental hygienists, and dental assistants.
Measured: 3 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJan 2004
- Primary completionNov 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Judith S. Gordon, Ph.D, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384254
- Sponsor's protocol ID
- DA 17972
- Other IDs
- R01DA017972
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2006
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH. The 5A's vs 3A's plus proactive quitline referral in private practice dental offices: preliminary results. Tob Control. 2007 Aug;16(4):285-8. doi: 10.1136/tc.2007.020271.
PubMed 17652247Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH, Lichtenstein E. Do faxed quitline referrals add value to dental office-based tobacco-use cessation interventions? J Am Dent Assoc. 2010 Aug;141(8):1000-7. doi: 10.14219/jada.archive.2010.0314.
PubMed 20675426Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention
- ClinicalTrials.gov ID
- NCT00384254
- Acronym / sponsor ID
- DA 17972
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco., Cessation., Dental patients., Dentists., Hygienists., Dental assistants., Health care providers., Behavioral intervention.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,177 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Care Control: Patients receive treatment as usual |
| 2 | Experimental | Behavioral: 5 A"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. |
| 3 | Experimental | Behavioral: 3 A"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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Dental patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 ADental 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. | Behavioural | 2 |
| 3 AProviders 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. | Behavioural | 3 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Results publication: PubMed 17652247Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH. The 5A's vs 3A's plus proactive quitline referral in private practice dental offices: preliminary results. Tob Control. 2007 Aug;16(4):285-8. doi: 10.1136/tc.2007.020271.
- Results publication: PubMed 20675426Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH, Lichtenstein E. Do faxed quitline referrals add value to dental office-based tobacco-use cessation interventions? J Am Dent Assoc. 2010 Aug;141(8):1000-7. doi: 10.14219/jada.archive.2010.0314.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith S. Gordon, Ph.D principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5 A and 3 A in people with Tobacco Use Cessation, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention. (time frame: 3 and 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384254, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.