Smoking
Conditions
Keywords
Decision Support Systems, Clinical, Smoking reduction, Smoking cessation, Smoking, Tobacco
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.
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.
Interventions
OTHERClinical 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
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Sydney
University of Pittsburgh
Indiana University
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Smokers With Initial Actions Related to Cessation | within a week of index dental encounter | 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. |
| Percentage of Smokers With Long-term Actions Related to Cessation | within six-months of index dental encounter | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care, practitioners review clinical guidelines for tobacco during consent process. | 13 |
| 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. | 43 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 17 |
Baseline characteristics
| Characteristic | Usual Care | Clinical Decision Support | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 43 Participants | 56 Participants |
| Age, Continuous | 44.2 years STANDARD_DEVIATION 19.2 | 41.8 years STANDARD_DEVIATION 14.9 | 42.3 years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 40 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 31 Participants | 42 Participants |
| Region of Enrollment United States | 13 participants | 43 participants | 56 participants |
| Sex: Female, Male Female | 5 Participants | 35 Participants | 40 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 43 |
| other Total, other adverse events | 0 / 13 | 0 / 43 |
| serious Total, serious adverse events | 0 / 13 | 0 / 43 |
Outcome results
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.
Time frame: within a week of the index dental encounter
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment | 7 Participants |
| Clinical Decision Support | Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment | 36 Participants |
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.
Time frame: within a week of index dental encounter
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Smokers With Initial Actions Related to Cessation | 3 Participants |
| Clinical Decision Support | Percentage of Smokers With Initial Actions Related to Cessation | 20 Participants |
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.
Time frame: within six-months of index dental encounter
Population: The numbers represented here indicate that not all study participants completed questionnaires at 6 months and were lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Smokers With Long-term Actions Related to Cessation | 4 Participants |
| Clinical Decision Support | Percentage of Smokers With Long-term Actions Related to Cessation | 18 Participants |