Clinical trial NCT02347124: Promoting Oral Health Among Smokers Randomized Trial
Official title: Promoting Oral Health Among Tobacco Quitline Callers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Disease
Smoking
Keywords: smoking cessation
oral health care
tobacco quitlines
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Consumer Wellness Solutions
name: University of California
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2015-01-27
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 7 Day Point Prevalent Abstinence (PPA)
timeFrame: 6 month post-enrollment
measure: Professional Dental Care Utilization in Past 6 Months
timeFrame: 6 months post-enrollment
Secondary outcomes:
measure: 7 Day Point Prevalent Abstinence (PPA)
timeFrame: 2 months post-enrollment
measure: 7 Day Point Prevalent Smoking Abstinence (PPA)
timeFrame: 2 months post-enrollment
measure: 7 Day Point Prevalent Smoking Abstinence (PPA)
timeFrame: 6 months post-enrollment
Other outcomes:
measure: Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
timeFrame: Baseline to 2 months
measure: Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up
timeFrame: Baseline to 6 months
measure: Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up
timeFrame: Baseline to 2 months
measure: Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up
timeFrame: Baseline to 6 months
measure: Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up
timeFrame: Baseline to 2 months
measure: Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up
timeFrame: Baseline to 6 months
measure: Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up
timeFrame: Baseline to 2 months
measure: Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up
timeFrame: Baseline to 6 months
measure: Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up
timeFrame: Baseline to 2 months
measure: Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up
timeFrame: Baseline to 6 months
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Jennifer McClure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available.
citation: McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12.
citation: 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.
citation: Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8.