Tobacco UseQA-DDSNCT02570646
QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
A study testing QA-DDS in people with Tobacco Use, run by Jamie Studts at 1 site in United States.
Trial summary
Using a single-arm trial design, this study will examine the feasibility and acceptability of evaluating QuitAdvisorDDS, a clinical decision support software application designed to facilitate implementation of evidence-based tobacco treatment interventions into the dental setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- QA-DDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Nov 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receives dental care from a participating practitioner;
- Is age 18 or older;
- Self-reports tobacco use within the past month;
- Willing to comply with all study procedures and be available for the duration of the study;
- Willing to provide verbal informed consent;
- Has access to a telephone, and agrees to receive text messages, emails, or telephone calls related to the study. (The patient's preferred method of contact will be ascertained).
- Willing to be contacted on a regular basis by each of these entities: the practice;Regional Coordinators (RC) and/or University of Kentucky (UK) researchers; and
- Willing to provide contact information of one person living at a different address who will know the patient's whereabouts in the event the patient cannot be reached.
Who cannot join
- Psychiatric disability or mental illness judged by the practitioner to be clinically significant so as to preclude informed consent or compliance with procedures of study visits.
- Cognitive impairment judged by the practitioner to be significant so as to preclude informed consent or compliance with procedures of study visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40536-0086
About this study
Using a single-arm trial design, this study will examine the feasibility and acceptability of evaluating QuitAdvisorDDS, a clinical decision support software application designed to facilitate implementation of evidence-based tobacco treatment interventions into the dental setting. The study will examine the feasibility and acceptability of evaluating the impact of the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts as well as provider knowledge, attitudes, and practices regarding tobacco treatment. Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up, while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to serve as biochemical verification of smoking status.
- Conditions
- Tobacco Use
- Being tested
- QA-DDS
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QA-DDSBehavioural
Also called QuitAdvisorDDS
QuitAdvisorDDS is a point-of-care software tool to facilitate implementation of evidence-based tobacco treatment interventions in dental care settings.
| Study group | Role | What they receive |
|---|---|---|
| QA-DDS | Experimental | Patients will receive exposure to the QA-DDS tool from their dental care practitioner. Receives: Behavioral: QA-DDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS
80% of participating patients must indicate that they would want their dental practitioner to continue to use QA-DDS.
Measured: Immediately Post-Consultation up to 1 week
Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal
80% of participating patients must indicate that they would want to continue to use the QA-DDS Patient Portal.
Measured: 1-Month Follow-Up
Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey
80% of the enrolled dental care patients must complete the 1-month follow-up survey with the 7-day point prevalence measure of self-reported smoking status.
Measured: 1-Month Follow-Up
Secondary outcomes (2)
Secondary Patient Acceptability A: Average QA-DDS Satisfaction Ratings Among Patients on 0-10 Scale
Average QA-DDS satisfaction ratings among enrolled dental patients must be 7 or greater on a 0-10 scale.
Measured: Immediately Post-Consultation up to 1 week
Secondary Patient Feasibility A: Rate of Patient Accrual by Study Practices
75% of the study practices must recruit 10 eligible dental patients within a 4-month recruitment phase
Measured: 4-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamie Studts
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Alabama at Birmingham, The National Dental Practice-Based Research Network, Health Decision Technologies, LLC
- Responsible party
- Sponsor-investigator, Jamie Studts, University of Kentucky
- Investigators
- Jamie L Studts, PhD, Principal investigator, Associate Professor, University of Kentucky College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570646
- Sponsor's protocol ID
- 10-155-E
- Other IDs
- R44DE021327
- Acronym
- QA-DDS
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2015
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 33605440
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
- ClinicalTrials.gov ID
- NCT02570646
- Acronym / sponsor ID
- QA-DDS / 10-155-E
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Jamie StudtsUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Alabama at Birmingham, The National Dental Practice-Based Research Network, Health Decision Technologies, LLC
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Oct 2015 (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.
Using a single-arm trial design, this study will examine the feasibility and acceptability of evaluating QuitAdvisorDDS, a clinical decision support software application designed to facilitate implementation of evidence-based tobacco treatment interventions into the dental setting. The study will examine the feasibility and acceptability of evaluating the impact of the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts as well as provider knowledge, attitudes, and practices regarding tobacco treatment. Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up, while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to serve as biochemical verification of smoking status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QA-DDS | Experimental | Behavioral: QA-DDSPatients will receive exposure to the QA-DDS tool from their dental care practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Receives dental care from a participating practitioner;
- Is age 18 or older;
- Self-reports tobacco use within the past month;
- Willing to comply with all study procedures and be available for the duration of the study;
- Willing to provide verbal informed consent;
Key exclusion criteria (2 listed)
- Psychiatric disability or mental illness judged by the practitioner to be clinically significant so as to preclude informed consent or compliance with procedures of study visits.
- Cognitive impairment judged by the practitioner to be significant so as to preclude informed consent or compliance with procedures of study visits.
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 |
|---|---|---|
| QA-DDSAlso: QuitAdvisorDDSQuitAdvisorDDS is a point-of-care software tool to facilitate implementation of evidence-based tobacco treatment interventions in dental care settings. | Behavioural | QA-DDS |
Primary outcome
Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS
Time frame: Immediately Post-Consultation up to 1 week
80% of participating patients must indicate that they would want their dental practitioner to continue to use QA-DDS.
Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal
Time frame: 1-Month Follow-Up
80% of participating patients must indicate that they would want to continue to use the QA-DDS Patient Portal.
Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey
Time frame: 1-Month Follow-Up
80% of the enrolled dental care patients must complete the 1-month follow-up survey with the 7-day point prevalence measure of self-reported smoking status.
2 secondary outcomes
Secondary Patient Acceptability A: Average QA-DDS Satisfaction Ratings Among Patients on 0-10 Scale
Time frame: Immediately Post-Consultation up to 1 week
Secondary Patient Feasibility A: Rate of Patient Accrual by Study Practices
Time frame: 4-Month Follow-Up
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 3 Apr 2019.
- 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.
Jamie L Studts, PhD principal investigator
Associate Professor, University of Kentucky College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QA-DDS in people with Tobacco Use, run by Jamie Studts 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 8 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 3 Apr 2019. 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?
Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (time frame: Immediately Post-Consultation up to 1 week). The study lists 3 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 NCT02570646, which also lists 1 linked publication.
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 3 Apr 2019.