Promoting Oral Health Among Smokers Randomized Trial

Kaiser Permanente

Status: Completed

Conditions: Smoking; Oral Disease

Treatments: Behavioral: Usual Care Control; Behavioral: Enhanced Intervention

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02347124

U01DE024462-01 (U.S. NIH Grant/Contract)

14-047-E

Details and patient eligibility

About

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].
2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome].
3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Full description

Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.

Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.

Enrollment: 718 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18 or older
• Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
• Can read and speak in English
• Current daily smoker and smokes at least 5 cigarettes a day
• Interested in quitting smoking in next 30 days
• Have some or all natural teeth
• Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
• Has a cell phone capable of receiving text messages and provides cell phone number
• Has internet access for personal use
• Willing to talk about ways to improve their oral health
• Provides verbal consent to participate

Exclusion criteria

• Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
• Have lived at the current address less than 6 months or plans to move in the next 6 months
• Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
• Has a household member already enrolled in the study, based on self-report and/or mailing address on file

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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718 participants in 2 patient groups

Usual Care Control

Active Comparator group

Description:

Standard tobacco quitline counseling program and materials + attention-matched text messaging.

Treatment:

Behavioral: Usual Care Control

Enhanced Intervention

Experimental group

Description:

Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .

Treatment:

Behavioral: Enhanced Intervention