Clinical trial NCT02570646: QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
Official title: QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: University of Alabama at Birmingham
name: The National Dental Practice-Based Research Network
name: Health Decision Technologies, LLC
First posted: 2015-10-07
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS
timeFrame: Immediately Post-Consultation up to 1 week
measure: Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal
timeFrame: 1-Month Follow-Up
measure: Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey
timeFrame: 1-Month Follow-Up
Secondary outcomes:
measure: Secondary Patient Acceptability A: Average QA-DDS Satisfaction Ratings Among Patients on 0-10 Scale
timeFrame: Immediately Post-Consultation up to 1 week
measure: Secondary Patient Feasibility A: Rate of Patient Accrual by Study Practices
timeFrame: 4-Month Follow-Up
Other outcomes:
measure: Tertiary Patient Acceptability A1: Number of Patients Who Visit QA-DDS Patient Portal
timeFrame: 1-Month Follow-Up
measure: Tertiary Patient Acceptability A2: Number of Visits to QA-DDS Patient Portal Per Patient
timeFrame: 1-Month Follow-Up
measure: Tertiary Patient Acceptability B: Rate of QA-DDS Text Messaging Support Service Use as Measured by Number of Patient Subscriptions
timeFrame: 1-Month Follow-Up
measure: Tertiary Patient Feasibility A: Rate of Missing Data for Tobacco Use Among Patients
timeFrame: 1-Month Follow-Up
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: Associate Professor, University of Kentucky College of Medicine
name: Jamie L Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.