SmokingENGAGENCT03656874
Engaging Patients in Tobacco Cessation Resources in Dental Settings
A study testing Clinical Decision Support in people with Smoking, run by HealthPartners Institute at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Clinical Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Mar 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3rd 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
- Current cigarette smokers
Who cannot join
- 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
- patients requesting to opt out of research
Trial locations and contacts
3 sites in 1 country.
United States3 sites
HealthPartners Institute
Bloomington, Minnesota, 55425
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15261
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Clinical Decision Support
- Keywords
- Decision Support Systems, Clinical, Smoking reduction, Smoking cessation, Smoking, Tobacco
- Medical subject headings
- Smoking, Smoking Reduction, Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision SupportOther
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
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care, practitioners review clinical guidelines for tobacco during consent process. |
| Clinical Decision Support | Experimental | 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. Receives: Other: Clinical Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within a week of the index dental encounter
Secondary outcomes (2)
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.
Measured: 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.
Measured: within six-months of index dental encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start29 Mar 2019
- Primary completion30 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Sydney, University of Pittsburgh, Indiana University
- Responsible party
- Sponsor
- Investigators
- D. Brad Rindal, DDS, Principal investigator, HealthPartners InstituteHeiko Spallek, DMD,PhD,MSBA, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656874
- Sponsor's protocol ID
- A15-107
- Other IDs
- U01DE026135
- Acronym
- ENGAGE
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2018
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinic-randomized Trial of a Clinical Decision Support System to Improve Dental Provider Delivery of Brief Tobacco Interventions and Quitline Referrals
- ClinicalTrials.gov ID
- NCT03656874
- Acronym / sponsor ID
- ENGAGE / A15-107
- Conditions
- Smoking
- Keywords
- Decision Support Systems, Clinical, Smoking reduction, Smoking cessation, Smoking, Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Sydney, University of Pittsburgh, Indiana University
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care, practitioners review clinical guidelines for tobacco during consent process. |
| Clinical Decision Support | Experimental | Other: Clinical Decision SupportThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 3rd 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
- Current cigarette smokers
Key exclusion criteria (4 listed)
- 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
- patients requesting to opt out of research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision SupportThe 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 |
Primary outcome
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.
2 secondary outcomes
Percentage of Smokers With Initial Actions Related to Cessation
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33605440Holliday 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Brad Rindal, DDS principal investigator
HealthPartners Institute
Heiko Spallek, DMD,PhD,MSBA principal investigator
University of Sydney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support in people with Smoking, run by HealthPartners Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment (time frame: within a week of the index dental encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.