SmokingCATINCT01584882
Computer-Assisted Tobacco Interventions in Dental Offices
A study testing CATI Tool in people with Smoking, run by HealthPartners Institute at 1 site in United States.
Trial summary
Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- CATI Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2012
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult dental patient presenting for an exam visit whose most recent history reports the patient is a smoker. Patients had to agree to the phone survey.
Who cannot join
- Research opt out list
- Patients who discontinued the survey prior to completion(considered withdrawals)
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Bloomington, Minnesota, 55445
About this study
Official title: Computer-Assisted Guidance for Tobacco Dependence Interventions in Dental Offices
Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.
- Conditions
- Smoking
- Being tested
- CATI Tool
- Keywords
- Clinical decision support (CDS), Tobacco, Behavioral, Dental hygienist, Dentist, Smoking, Electronic health record
- Medical subject headings
- Smoking, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATI ToolBehavioural
Using Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a CATI tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details.
| Study group | Role | What they receive |
|---|---|---|
| Control (Usual care) | No intervention | Return patients seen within the data collection window in HealthPartners Dental Clinics (new patient exams were excluded) who were documented as using tobacco, specifically cigarettes, at their last dental encounter. Randomization was at the clinic level. |
| Tobacco Cessation Tool (CATI Tool) | Experimental | Using Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a 'CATI'[Computer Assisted Tobacco Intervention] tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details. Receives: Behavioral: CATI Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient report
Patient report of dental providers delivery of:
- Screening for tobacco
- Discussion of specific strategies to assist the patient with quitting smoking
- Referral to a Quitline (toll free number for comprehensive tobacco cessation support)
Measured: Within 3 days of the dental encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. Brad Rindal, DDS, Principal investigator, HealthPartners Researc Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584882
- Sponsor's protocol ID
- 09-062
- Acronym
- CATI
- Status last verified
- Jul 2014
- First submitted
- 23 Apr 2012
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Holliday 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 33605440Rindal DB, Rush WA, Schleyer TK, Kirshner M, Boyle RG, Thoele MJ, Asche SE, Thyvalikakath T, Spallek H, Durand EC, Enstad CJ, Huntley CL. Computer-assisted guidance for dental office tobacco-cessation counseling: a randomized controlled trial. Am J Prev Med. 2013 Mar;44(3):260-4. doi: 10.1016/j.amepre.2012.10.023.
PubMed 23415123
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Guidance for Tobacco Dependence Interventions in Dental Offices
- ClinicalTrials.gov ID
- NCT01584882
- Acronym / sponsor ID
- CATI / 09-062
- Conditions
- Smoking
- Keywords
- Clinical decision support (CDS), Tobacco, Behavioral, Dental hygienist, Dentist, Smoking, Electronic health record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Apr 2012 (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.
Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Usual care) | No intervention | –Return patients seen within the data collection window in HealthPartners Dental Clinics (new patient exams were excluded) who were documented as using tobacco, specifically cigarettes, at their last dental encounter. Randomization was at the clinic level. |
| Tobacco Cessation Tool (CATI Tool) | Experimental | Behavioral: CATI ToolUsing Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a 'CATI'[Computer Assisted Tobacco Intervention] tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult dental patient presenting for an exam visit whose most recent history reports the patient is a smoker. Patients had to agree to the phone survey.
Key exclusion criteria (2 listed)
- Research opt out list
- Patients who discontinued the survey prior to completion(considered withdrawals)
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 |
|---|---|---|
| CATI ToolUsing Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a CATI tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details. | Behavioural | Tobacco Cessation Tool (CATI Tool) |
Primary outcome
Patient report
Time frame: Within 3 days of the dental encounter
Patient report of dental providers delivery of: 1. Screening for tobacco 2. Discussion of specific strategies to assist the patient with quitting smoking 3. Referral to a Quitline (toll free number for comprehensive tobacco cessation support)
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 23 Aug 2023.
- 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 23415123Rindal DB, Rush WA, Schleyer TK, Kirshner M, Boyle RG, Thoele MJ, Asche SE, Thyvalikakath T, Spallek H, Durand EC, Enstad CJ, Huntley CL. Computer-assisted guidance for dental office tobacco-cessation counseling: a randomized controlled trial. Am J Prev Med. 2013 Mar;44(3):260-4. doi: 10.1016/j.amepre.2012.10.023.
- HealthPartners Research FoundationLink provided by the sponsor.
Related trials for Smoking
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
D. Brad Rindal, DDS principal investigator
HealthPartners Researc Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATI Tool in people with Smoking, run by HealthPartners 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 1 inclusion and 2 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 23 Aug 2023. 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.
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?
Patient report (time frame: Within 3 days of the dental encounter). 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 NCT01584882, which also lists 2 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 23 Aug 2023.