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

April 1, 2019 updated by: Jamie Studts
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately Post-Consultation up to 1 week
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.
1-Month Follow-Up
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.
1-Month Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Immediately Post-Consultation up to 1 week
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
4-Month Follow-Up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1-Month Follow-Up
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
1-Month Follow-Up
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.
1-Month Follow-Up
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.
1-Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jamie Studts

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie L Studts, PhD, Associate Professor, University of Kentucky College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-155-E
  • R44DE021327 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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