QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings

NCT02570646 | Completed DMC

• 2 other identifiers: 10-155-ER44DE021327
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Secondary Patient Acceptability A: Average QA-DDS Satisfaction Ratings Among Patients on 0-10 Scale

  Immediately Post-Consultation up to 1 week

• Secondary Patient Feasibility A: Rate of Patient Accrual by Study Practices

  4-Month Follow-Up

Other Outcomes (4)

• Tertiary Patient Acceptability A1: Number of Patients Who Visit QA-DDS Patient Portal

  1-Month Follow-Up

• Tertiary Patient Acceptability A2: Number of Visits to QA-DDS Patient Portal Per Patient

  1-Month Follow-Up

• Tertiary Patient Acceptability B: Rate of QA-DDS Text Messaging Support Service Use as Measured by Number of Patient Subscriptions

  1-Month Follow-Up

Study Arms (1)

QA-DDS

EXPERIMENTAL

Patients will receive exposure to the QA-DDS tool from their dental care practitioner.

Behavioral: QA-DDS

Interventions

QA-DDS BEHAVIORAL

QuitAdvisorDDS is a point-of-care software tool to facilitate implementation of evidence-based tobacco treatment interventions in dental care settings.

Also known as: QuitAdvisorDDS

QA-DDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jamie Studts: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• University of Alabama at Birmingham: collaborator
• The National Dental Practice-Based Research Network: collaborator
• Health Decision Technologies, LLC: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0086, United States

Location

Related Publications (1)

• 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.

  PMID: 33605440 DERIVED

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jamie L Studts, PhD

  Associate Professor, University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 3, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)