Engaging Patients in Tobacco Cessation Resources in Dental Settings

Smoking Clinical Trial

— ENGAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656874
• Other study ID #: A15-107
• Secondary ID: U01DE026135
• Status: Completed
• Phase: N/A
• Start date: March 29, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2022
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota
United States	Indiana University School of Dentistry	Indianapolis	Indiana
United States	University of Pittsburgh School of Dental Medicine	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
HealthPartners Institute	Indiana University, National Institute of Dental and Craniofacial Research (NIDCR), University of Pittsburgh, University of Sydney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Smokers With Initial Actions Related to Cessation	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
Secondary	Percentage of Smokers With Long-term Actions Related to Cessation	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