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

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: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Clinical Decision Support

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: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: University of Pittsburgh; National Institute of Dental and Craniofacial Research (NIDCR); Indiana University; University of Sydney
• Investigators: Principal Investigator: Heiko Spallek, DMD,PhD,MSBA, University of Sydney

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Smoking cessation; Decision Support Systems, Clinical; Smoking, Tobacco; Smoking reduction
• Other Study ID 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