Engaging Patients in Tobacco Cessation Resources in Dental Settings
ENGAGE
A Clinic-randomized Trial of a Clinical Decision Support System to Improve Dental Provider Delivery of Brief Tobacco Interventions and Quitline Referrals
2 other identifiers
interventional
56
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedStudy Start
First participant enrolled
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
June 28, 2022
CompletedJune 28, 2022
March 1, 2022
1.8 years
August 31, 2018
March 23, 2022
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment
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 Outcomes (2)
Percentage of Smokers With Initial Actions Related to Cessation
within a week of index dental encounter
Percentage of Smokers With Long-term Actions Related to Cessation
within six-months of index dental encounter
Study Arms (2)
Usual Care
NO INTERVENTIONUsual care, practitioners review clinical guidelines for tobacco during consent process.
Clinical Decision Support
EXPERIMENTALThe 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- rd and 4th year predoctoral students or dental hygiene students enrolled at selected dental schools
- PRIVATE PRACTICE DENTISTS \& HYGIENISTS
- General practice dentists or dental hygienists practicing at selected private practice clinics
You may not qualify if:
- 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
- Current cigarette smokers
- patients requesting to opt out of research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- University of Sydneycollaborator
- University of Pittsburghcollaborator
- Indiana Universitycollaborator
Study Sites (3)
Indiana University School of Dentistry
Indianapolis, Indiana, 46202, United States
HealthPartners Institute
Bloomington, Minnesota, 55425, United States
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15261, United States
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: 33605440DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Technological interface issues and coronavirus disease (COVID) were limitations of the study.
Results Point of Contact
- Title
- Dr. D. Brad Rindal
- Organization
- HealthPartners Institute
Study Officials
- PRINCIPAL INVESTIGATOR
D. Brad Rindal, DDS
HealthPartners Institute
- PRINCIPAL INVESTIGATOR
Heiko Spallek, DMD,PhD,MSBA
University of Sydney
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2018
First Posted
September 4, 2018
Study Start
March 29, 2019
Primary Completion
December 30, 2020
Study Completion
June 30, 2021
Last Updated
June 28, 2022
Results First Posted
June 28, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.