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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570646
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
University of Alabama at Birmingham
The National Dental Practice-Based Research Network
Health Decision Technologies, LLC
Information provided by (Responsible Party):
Jamie Studts, University of Kentucky

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: QA-DDS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016
Arms and Interventions
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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 Name: QuitAdvisorDDS


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570646


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0086
Sponsors and Collaborators
Jamie Studts
National Institute of Dental and Craniofacial Research (NIDCR)
University of Alabama at Birmingham
The National Dental Practice-Based Research Network
Health Decision Technologies, LLC
Investigators
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Principal Investigator: Jamie L Studts, PhD Associate Professor, University of Kentucky College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jamie Studts, Principle investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02570646    
Other Study ID Numbers: 10-155-E
R44DE021327 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019