Tobacco Use DisorderEarly Phase 1DTCNCT00627185
Dental Tobacco Control.Net:Improving Practice
A Early Phase 1 study testing Internet-delivered continuing professional development in people with Tobacco Use Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Internet-delivered continuing professional development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2008
- Phase
- Early Phase 1
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- general dental practices that have internet access
- Periodontal practices that have internet access
- patients of participating dental or periodontal practices
Who cannot join
- patients who were 18 years of age and younger
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. The intervention involves surveying practices regarding preventive care, surveying adult patients about their tobacco habits and preventive care provided by dental practice and training/educating the dentist and office staff on tobacco cessation. With patients who smoke and indicate that they have quit, we followed up with testing their saliva for the presence of cotinine. We have enrolled general dentists and periodontists who practice in the Southeastern United States.
Read the detailed description
Tobacco use has been described as the number one behavioral health problem of our time with a projected 8.4 million total smoking related deaths worldwide by the year 2020. Current clinical practice guidelines entitled "Treating Tobacco Use and Dependence" provide a summary of evidence-based recommendations. Despite the evidence of tobacco risk and the efficacy of tobacco control interventions, 30% of current smokers report that they have never been advised to stop smoking by a healthcare provider. Nearly half (47.9%) of dentists report they have never intervened to assist tobacco users in quitting. Our intervention is designed to improve the rate of tobacco cessation advice delivered in dental practices.
This proposal is in response to the request for applications "Translational Research in Dental Practice-based Tobacco Control Interventions" (RFA: DE-03-007). Our exploration of barriers and facilitators will assist in clarifying processes that influence translation of tobacco-related knowledge into clinical dental practice. Our trial will integrate theoretically grounded methods of provider behavior change, medical informatics, and tobacco control research to translate guidelines into dental clinical practice. We will avoid a "one-size-fits-all" approach by tailoring strategies for tobacco cessation counseling to individual practices. The intervention will be longitudinal, with updates and continuous access for dentists and dental staff over 2 years. Our evaluation will extend from processes of care to patient outcomes. Ancillary analyses will assess differences in tobacco counseling rates associated with practice, provider, and patient-level variables including disparities in counseling by race. To assess the relative impact of various components of the multi-modal intervention, we will conduct secondary analyses of the association of amount of use of each specific component with frequency of tobacco cessation counseling within the intervention group.
- Conditions
- Tobacco Use Disorder
- Being tested
- Internet-delivered continuing professional development, No intervention arm
- Keywords
- Tobacco control, Tobacco cessation, Tobacco use
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered continuing professional developmentBehavioural
Also called Internet, Quality Assurance, Health Care, Tobacco Use Cessation
Interactive motivational website for dentists and hygienists with practice improvement resources, discussion forum, and educational cases on cessation counseling with email reminders.
No intervention armOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention group (dental practices) that received the interactive motivational website for patient tobacco cessation Receives: Behavioral: Internet-delivered continuing professional development |
| 2 | Placebo comparator | Control group (dental practices) that did not receive any materials or resources on tobacco cessation. This is a wait-list control. Receives: Other: No intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice.
Measured: Baseline, 8-months post-intervention, and 24-months post-intervention
Secondary outcomes (1)
Point prevalence smoking cessation
Measured: six-months after index visit for patients who smoke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startSep 2003
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas K Houston, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627185
- Sponsor's protocol ID
- X030814016
- Other IDs
- R01DA017971
- Acronym
- DTC
- Status last verified
- Aug 2010
- First submitted
- 14 Feb 2008
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Houston TK, Funkhouser E, Allison JJ, Levine DA, Williams OD, Kiefe CI. Multiple measures of provider participation in Internet delivered interventions. Stud Health Technol Inform. 2007;129(Pt 2):1401-5.
PubMed 17911944Houston TK, Richman JS, Ray MN, Allison JJ, Gilbert GH, Shewchuk RM, Kohler CL, Kiefe CI; DPBRN Collaborative Group. Internet delivered support for tobacco control in dental practice: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e38. doi: 10.2196/jmir.1095.
PubMed 18984559Holliday 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 33605440Houston TK, Delaughter KL, Ray MN, Gilbert GH, Allison JJ, Kiefe CI, Volkman JE; National Dental PBRN Collaborative Group. Cluster-randomized trial of a web-assisted tobacco quality improvement intervention of subsequent patient tobacco product use: a National Dental PBRN study. BMC Oral Health. 2013 Feb 23;13:13. doi: 10.1186/1472-6831-13-13.
PubMed 23438090
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Tobacco Control.Net:Improving Practice
- ClinicalTrials.gov ID
- NCT00627185
- Acronym / sponsor ID
- DTC / X030814016
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco control, Tobacco cessation, Tobacco use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Feb 2008 (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.
This is a randomized, controlled trial (RCT) to test the efficacy of an internet continuing dental education intervention designed to increase tobacco cessation counseling in dental practices. The intervention involves surveying practices regarding preventive care, surveying adult patients about their tobacco habits and preventive care provided by dental practice and training/educating the dentist and office staff on tobacco cessation. With patients who smoke and indicate that they have quit, we followed up with testing their saliva for the presence of cotinine. We have enrolled general dentists and periodontists who practice in the Southeastern United States.
Detailed description
Tobacco use has been described as the number one behavioral health problem of our time with a projected 8.4 million total smoking related deaths worldwide by the year 2020. Current clinical practice guidelines entitled "Treating Tobacco Use and Dependence" provide a summary of evidence-based recommendations. Despite the evidence of tobacco risk and the efficacy of tobacco control interventions, 30% of current smokers report that they have never been advised to stop smoking by a healthcare provider. Nearly half (47.9%) of dentists report they have never intervened to assist tobacco users in quitting. Our intervention is designed to improve the rate of tobacco cessation advice delivered in dental practices.
This proposal is in response to the request for applications "Translational Research in Dental Practice-based Tobacco Control Interventions" (RFA: DE-03-007). Our exploration of barriers and facilitators will assist in clarifying processes that influence translation of tobacco-related knowledge into clinical dental practice. Our trial will integrate theoretically grounded methods of provider behavior change, medical informatics, and tobacco control research to translate guidelines into dental clinical practice. We will avoid a "one-size-fits-all" approach by tailoring strategies for tobacco cessation counseling to individual practices. The intervention will be longitudinal, with updates and continuous access for dentists and dental staff over 2 years. Our evaluation will extend from processes of care to patient outcomes. Ancillary analyses will assess differences in tobacco counseling rates associated with practice, provider, and patient-level variables including disparities in counseling by race. To assess the relative impact of various components of the multi-modal intervention, we will conduct secondary analyses of the association of amount of use of each specific component with frequency of tobacco cessation counseling within the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Internet-delivered continuing professional developmentIntervention group (dental practices) that received the interactive motivational website for patient tobacco cessation |
| 2 | Placebo comparator | Other: No intervention armControl group (dental practices) that did not receive any materials or resources on tobacco cessation. This is a wait-list control. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- general dental practices that have internet access
- Periodontal practices that have internet access
- patients of participating dental or periodontal practices
Key exclusion criteria (1 listed)
- patients who were 18 years of age and younger
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 |
|---|---|---|
| Internet-delivered continuing professional developmentAlso: Internet, Quality Assurance, Health Care, Tobacco Use CessationInteractive motivational website for dentists and hygienists with practice improvement resources, discussion forum, and educational cases on cessation counseling with email reminders. | Behavioural | 1 |
| No intervention arm | Other | 2 |
Primary outcome
Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice.
Time frame: Baseline, 8-months post-intervention, and 24-months post-intervention
1 secondary outcome
Point prevalence smoking cessation
Time frame: six-months after index visit for patients who smoke
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 9 Mar 2015.
- Background: PubMed 17911944Houston TK, Funkhouser E, Allison JJ, Levine DA, Williams OD, Kiefe CI. Multiple measures of provider participation in Internet delivered interventions. Stud Health Technol Inform. 2007;129(Pt 2):1401-5.
- Results publication: PubMed 18984559Houston TK, Richman JS, Ray MN, Allison JJ, Gilbert GH, Shewchuk RM, Kohler CL, Kiefe CI; DPBRN Collaborative Group. Internet delivered support for tobacco control in dental practice: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e38. doi: 10.2196/jmir.1095.
- 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.
- Derived from this study: PubMed 23438090Houston TK, Delaughter KL, Ray MN, Gilbert GH, Allison JJ, Kiefe CI, Volkman JE; National Dental PBRN Collaborative Group. Cluster-randomized trial of a web-assisted tobacco quality improvement intervention of subsequent patient tobacco product use: a National Dental PBRN study. BMC Oral Health. 2013 Feb 23;13:13. doi: 10.1186/1472-6831-13-13.
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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.
Thomas K Houston, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Internet-delivered continuing professional development in people with Tobacco Use Disorder, run by University of Alabama at Birmingham 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 3 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 9 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (time frame: Baseline, 8-months post-intervention, and 24-months post-intervention). 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 NCT00627185, which also lists 4 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 9 Mar 2015.