Tobacco Use Clinical Trial
— QA-DDSOfficial title:
QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
Verified date | April 2019 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 248 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Jamie Studts | Health Decision Technologies, LLC, National Institute of Dental and Craniofacial Research (NIDCR), The National Dental Practice-Based Research Network, University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tertiary Patient Acceptability A1: Number of Patients Who Visit QA-DDS Patient Portal | To evaluate the acceptability of the QA-DDS Patient Portal among enrolled dental patients, the percentage of enrolled patients who make at least one visit to the Patient Portal will be monitored | 1-Month Follow-Up | |
Other | Tertiary Patient Acceptability A2: Number of Visits to QA-DDS Patient Portal Per Patient | To evaluate the acceptability of the QA-DDS Patient Portal among enrolled dental patients, the number of visits to the Patient Portal per patient will be monitored | 1-Month Follow-Up | |
Other | Tertiary Patient Acceptability B: Rate of QA-DDS Text Messaging Support Service Use as Measured by Number of Patient Subscriptions | To evaluate the acceptability of the QA-DDS Text Messaging Support Service, the percentage of enrolled patients who subscribe to the Text Messaging Support Service will be monitored. | 1-Month Follow-Up | |
Other | Tertiary Patient Feasibility A: Rate of Missing Data for Tobacco Use Among Patients | Self-reported measures of tobacco use and history at the follow-up assessment must have less than 10% missing data among responding dental patients. | 1-Month Follow-Up | |
Primary | 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. | Immediately Post-Consultation up to 1 week | |
Primary | 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. | 1-Month Follow-Up | |
Primary | 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. | 1-Month Follow-Up | |
Secondary | 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. | Immediately Post-Consultation up to 1 week | |
Secondary | 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 | 4-Month Follow-Up |
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