Engaging Patients in Tobacco Cessation Resources in Dental Settings (ENGAGE)

June 22, 2022 updated by: HealthPartners Institute

A Clinic-randomized Trial of a Clinical Decision Support System to Improve Dental Provider Delivery of Brief Tobacco Interventions and Quitline Referrals

The overarching goal of this project is to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling. Using a stratified, group-randomized, controlled, 2-arm trial conducted in two settings, the investigators will compare smoking-related clinical decision support (CDS) to usual care.

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.

Detailed Description

This project aims to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling. The study team will evaluate the effectiveness of clinical decision support (CDS) to improve dental provider delivery of brief tobacco interventions and referrals to tobacco quitlines for further tobacco counseling. The CDS will generate personalized, evidence-based recommendations for dentists and dental hygienists to actively engage their smoking patients in the course of usual dental care. Subsequently, the study team will assess the tobacco cessation actions of smokers using patient-centered outcomes.

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.
56

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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Dentistry
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartners Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Dental Medicine

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

No

Genders Eligible for Study

All

Description

DENTAL STUDENTS AND DENTAL HYGIENE STUDENTS

Inclusion Criteria:

  • 3rd and 4th year predoctoral students or dental hygiene students enrolled at selected dental schools

PRIVATE PRACTICE DENTISTS & HYGIENISTS

Inclusion Criteria:

  • General practice dentists or dental hygienists practicing at selected private practice clinics

Exclusion Criteria:

  • Providers not able or willing to record current tobacco use status in their electronic health record
  • Providers affiliated with selected dental schools who hold a current teaching or clinical position

PATIENTS

Inclusion Criteria:

  • Current cigarette smokers

Exclusion Criteria:

  • patients requesting to opt out of research

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
No Intervention: Usual Care
Usual care, practitioners review clinical guidelines for tobacco during consent process.
Experimental: Clinical Decision Support
The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
Other: Clinical Decision Support
The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care

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
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment
Time Frame: within a week of the index dental encounter
Composite of provider actions reported by patient regarding delivery of brief interventions and/or referral to treatment. These actions included that the provider 1) delivered a brief smoking intervention by discussing, a)developing a quit plan or b)setting a quit date or c)using medications to help patients quit or d)discussed strategies for quitting. The provider made a 2) referral to a quitline; a)provided information about how to contact a tobacco quitline or b) arranged for the patient to be contacted by the tobacco quit line for smoking cessation. The composite is satisfied if the patient reports that any of the intervention activities or referral was delivered by the provider.
within a week of the index dental encounter

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
Percentage of Smokers With Initial Actions Related to Cessation
Time Frame: within a week of index dental encounter
Composite of patient-reported actions of smokers with initial actions related to cessation. This composite is met if the patient reported that they contacted a smoking cessation quitline, set a quit date, developed a plan to quit, or is starting nicotine replacement or other medication to help quit within 1-7 days of their index dental visit.
within a week of index dental encounter
Percentage of Smokers With Long-term Actions Related to Cessation
Time Frame: within six-months of index dental encounter
Composite of patient-reported actions of smokers with long-term actions related to cessation. This composite includes whether the patient reported that they quit smoking (stopped smoking for more than one day because they were trying to stop smoking), or reduced their smoking use (50% reduction in amount smoked at 6 months compared to baseline). This composite is satisfied if the patient reports that they have done any of these actions within the 6 months +/- 1 week period between the index dental visit and the date of the second patient survey.
within six-months of index dental encounter

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.
HealthPartners Institute

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 Pittsburgh
National Institute of Dental and Craniofacial Research (NIDCR)
Indiana University
University of Sydney

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: Heiko Spallek, DMD,PhD,MSBA, University of Sydney

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 (Actual)

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.
March 29, 2019

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.
December 30, 2020

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.
June 30, 2021

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).
August 31, 2018

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.
August 31, 2018

First Posted (Actual)

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.
September 4, 2018

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.
June 28, 2022

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.
June 22, 2022

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.
March 1, 2022

More Information

Terms related to this study

Keywords

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.
  • A15-107
  • U01DE026135 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of study outputs and resources is an essential element of this research. To facilitate the conduct of future research, we will make available de-identified datasets and technical resources from the completed project in a manner consistent with human subject protection and HIPAA privacy regulations. These resources will be subject to requirements imposed by the governing Institutional Review Board (IRB) and our organizational legal requirements.

IPD Sharing Time Frame

Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.

IPD Sharing Access Criteria

Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician. Study publications will note the method for requesting the study data and technical materials. The study statistician will provide data and accompanying files in an archived zip format to requesters via email. Data will not be stored in a public repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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