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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

within a week of the index dental encounter

Results posted on

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

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 encounter

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clinical Decision Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. D. Brad Rindal

HealthPartners Institute

Phone: 952.967.5026

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place