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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE026135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| University of Sydney | OTHER |
| University of Pittsburgh | OTHER |
| Indiana University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support | Other | 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 |
| 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 |
| 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. |
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DENTAL STUDENTS AND DENTAL HYGIENE STUDENTS
Inclusion Criteria:
PRIVATE PRACTICE DENTISTS & HYGIENISTS
Inclusion Criteria:
Exclusion Criteria:
PATIENTS
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Brad Rindal, DDS | HealthPartners Institute | Principal Investigator |
| Heiko Spallek, DMD,PhD,MSBA | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States | ||
| HealthPartners Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33605440 | Derived | 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. |
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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.
Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
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.
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Randomization occurred at the clinic level.107 patients were authorized at their dental clinic to be contacted for the study. 51 patients declined to be consented or were not able to be reached; 56 participants consented to participate in the study.
The study took place at two academic institutions and private practices in the community. Due to technical difficulties regarding the implementation of the Clinical Decision Support (CDS) tool into the school's electronic dental record, the two academic institutions were discontinued from the study. Private practice clinics in the community were the focus of the ongoing study with clinic randomization occurring between March 29, 2019 and December 30, 2019 for 9 months.
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care, practitioners review clinical guidelines for tobacco during consent process. |
| FG001 | Clinical Decision Support | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care, practitioners review clinical guidelines for tobacco during consent process. |
| BG001 | Clinical Decision Support | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | within a week of the index dental encounter |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care, practitioners review clinical guidelines for tobacco during consent process. |
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Technological interface issues and coronavirus disease (COVID) were limitations of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. D. Brad Rindal | HealthPartners Institute | 952.967.5026 | D.Brad.Rindal@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2021 | Apr 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2022 | Apr 29, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2019 | Jun 22, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000074264 | Smoking Reduction |
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D064424 | Tobacco Use |
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| OTHER |
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|
| 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 |
| Bloomington |
| Minnesota |
| 55425 |
| United States |
| University of Pittsburgh School of Dental Medicine | Pittsburgh | Pennsylvania | 15261 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Clinical Decision Support | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | The numbers represented here indicate that not all study participants completed questionnaires at 6 months and were lost to follow-up. | Posted | Count of Participants | Participants | within six-months of index dental encounter |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
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