Trial Outcomes & Findings for Engaging Patients in Tobacco Cessation Resources in Dental Settings (NCT NCT03656874)
NCT ID: NCT03656874
Last Updated: 2022-06-28
Results Overview
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.
COMPLETED
NA
56 participants
within a week of the index dental encounter
2022-06-28
Participant Flow
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.
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.
Unit of analysis: Clinics
Participant milestones
| Measure |
Usual Care
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13 4
|
43 6
|
|
Overall Study
COMPLETED
|
10 2
|
26 5
|
|
Overall Study
NOT COMPLETED
|
3 2
|
17 1
|
Reasons for withdrawal
| Measure |
Usual Care
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
17
|
Baseline Characteristics
Engaging Patients in Tobacco Cessation Resources in Dental Settings
Baseline characteristics by cohort
| Measure |
Usual Care
n=13 Participants
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
Clinical Decision Support
n=43 Participants
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.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 19.2 • n=99 Participants
|
41.8 years
STANDARD_DEVIATION 14.9 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
43 participants
n=107 Participants
|
56 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within a week of the index dental encounterComposite 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.
Outcome measures
| Measure |
Usual Care
n=13 Participants
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
Clinical Decision Support
n=43 Participants
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.
|
|---|---|---|
|
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment
|
7 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: within a week of index dental encounterComposite 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.
Outcome measures
| Measure |
Usual Care
n=13 Participants
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
Clinical Decision Support
n=43 Participants
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.
|
|---|---|---|
|
Percentage of Smokers With Initial Actions Related to Cessation
|
3 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: within six-months of index dental encounterPopulation: The numbers represented here indicate that not all study participants completed questionnaires at 6 months and were lost to follow-up.
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.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Usual care, practitioners review clinical guidelines for tobacco during consent process.
|
Clinical Decision Support
n=26 Participants
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.
|
|---|---|---|
|
Percentage of Smokers With Long-term Actions Related to Cessation
|
4 Participants
|
18 Participants
|
Adverse Events
Usual Care
Clinical Decision Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place