QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings (QA-DDS)

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 Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: QA-DDS

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0086
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QA-DDS; Patients will receive exposure to the QA-DDS tool from their dental care practitioner.	Behavioral: QA-DDS; QuitAdvisorDDS is a point-of-care software tool to facilitate implementation of evidence-based tobacco treatment interventions in dental care settings.; Other Names: QuitAdvisorDDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Jamie Studts
• Collaborators: University of Alabama at Birmingham; National Institute of Dental and Craniofacial Research (NIDCR); The National Dental Practice-Based Research Network; Health Decision Technologies, LLC
• Investigators: Principal Investigator: Jamie L Studts, PhD, Associate Professor, University of Kentucky College of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 3, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 10-155-E; R44DE021327 (U.S. NIH Grant/Contract)