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Completed

NCT Number: NCT02570646

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

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.

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Key information

Conditions

Tobacco Use Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536-0086, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QA-DDS

Behavioral

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

Other names: QuitAdvisorDDS

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: Immediately Post-Consultation up to 1 week

    Average QA-DDS satisfaction ratings among enrolled dental patients must be 7 or greater on a 0-10 scale.

  2. Secondary Patient Feasibility A: Rate of Patient Accrual by Study Practices

    Time frame: 4-Month Follow-Up

    75% of the study practices must recruit 10 eligible dental patients within a 4-month recruitment phase

Other outcomes

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

    Time frame: 1-Month Follow-Up

    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

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

    Time frame: 1-Month Follow-Up

    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

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

    Time frame: 1-Month Follow-Up

    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.

  4. Tertiary Patient Feasibility A: Rate of Missing Data for Tobacco Use Among Patients

    Time frame: 1-Month Follow-Up

    Self-reported measures of tobacco use and history at the follow-up assessment must have less than 10% missing data among responding dental patients.

Sponsors and collaborators

Lead sponsor

Jamie Studts

Other

Collaborators

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

Registry information

Acronym: QA-DDS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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