Smoking Cessation
Conditions
Keywords
video-based smoking cessation, smoking cessation evidence-based treatments (EBTs), text messages, dental cleaning, smoking cessation
Brief summary
The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group
Detailed description
Approximately 400 patients who have a scheduled prophylaxis, root planing and scaling dental appointment at the BUGSDM patient treatment center will be recruited and enrolled in the randomized controlled trial. Participants who complete the baseline survey will be randomized to either the intervention or control group. The intervention group will watch one of two smoking cessation videos during the appointment (depending on readiness to quit), receive a brochure about EBTs for smoking cessation, and participate in a 4-week tailored text message program designed to motivate EBT utilization. After the 4-week text message program, the intervention group will receive monthly assessment text messages for six months. The control group will watch a control video during the appointment, receive the same brochure about EBTs as the intervention group, and participate in an assessment-only 4-week text message program. All videos are approximately 10 minutes long. After the dental clinic appointment, all participants will complete an online questionnaire and begin the 4-week text message program. At the end of the 4-week text message program, and 3 and 6 months later, all participants will complete online questionnaires. Primary Aim 1: To test the efficacy of the intervention vs. control in increasing utilization of EBTs over the course of follow-up (7-months). Hypothesis 1.1: Smokers randomized to the intervention will be more likely to engage with (contact) EBTs. Hypothesis 1.2: Smokers randomized to the intervention will have greater treatment utilization (e.g., more days in the text message program, more days using smoking cessation medication, and more quitline counseling sessions, greater number of EBTs). Secondary Aims: Aim 2: To test the effect of the intervention vs. controls on quit attempts and on motivation to quit. Hypothesis 2: Smokers randomized to the intervention will have more quit attempts and higher motivation to quit. Aim 3: To test the efficacy of the intervention vs controls on biochemically verified abstinence. Hypothesis 3: Smokers randomized to the intervention will have higher quit rates at follow-up. Aim 4: To assess the mechanisms through which the intervention effects occur (social cognitive mediators) and to identify subpopulations for whom intervention effects differ (moderators, e.g., readiness to quit, gender, race/ethnicity). Hypothesis 4: The intervention will directly affect the putative mediators, which will in turn affect EBT utilization. The role of moderators will be exploratory.
Interventions
BEHAVIORALExperimental smoking cessation video
Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
BEHAVIORALControl video
Participants randomized to the control group will watch a 10 minute video.
OTHERBrochure of smoking cessation EBTs
All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
BEHAVIORALTailored text message program
Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
OTHERAssessment text messages
Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
Sponsors
Boston University
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Research assistants who are collecting outcome data will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient of the Boston University, Henry M Goldman School of Dental Medicine treatment center with an upcoming dental hygiene appointment (dental prophylaxis or scaling and root planing) * Self-reported smoking 100 cigarettes or more (not including e-cigarettes or vaping) in lifetime * Self-reported smoking any cigarette (not including e-cigarettes or vaping) in the preceding week * Self-reported cigarettes (not including e-cigarettes or vaping) 'some days', 'most days' or 'every day' in the preceding week * Is able to understand written and spoken study materials * Score of 'Never,' 'Rarely' or 'Sometimes' on the validated single-item literacy screener ("How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor, dentist, or pharmacy?") * Self-reported visual capacity to watch a video as indicated by the score 'Some difficulty' or 'No difficulty' to: "How much difficulty do you have with your vision, even when wearing glasses?" * Self-reported ability to wear headphones that are inserted partially inside the ear * Self-reported use of text messaging at least once in the preceding month * Self-reported access to necessary resources for intervention: Cell phone capable of text messaging * Live in Massachusetts * Stated willingness to comply with text message program procedures (receive and respond to text messages for 4-weeks)
Exclusion criteria
* Participation in another treatment or intervention study for smoking cessation or research involving text messaging * Current use of medications for smoking cessation or smoking reduction (nicotine replacement product, or non-nicotine medications) whether prescribed or not * Failure to complete the pre-dental clinic appointment procedure before the start of the dental appointment (opt-into the text message program and complete the baseline questionnaire) * Failure to show up to scheduled dental appointment at the clinic * Previous participation in the pilot phase * Could not watch video during dental appointment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation | 7 months | Self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study. EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline). |
| Verified Use of Any EBT for Smoking Cessation | 7 months | Objectively verified use of the following EBT: the text message program SmokefreeTXT and/or the Massachusetts state quitline. Verification of use will occur through review of usage databases from the vendors. |
| Use of Combination EBT for Smoking Cessation | 7 months | Self-reported use of combination EBT defined according to clinical guidelines as use of a pharmacologic product (NRT or non-nicotine medications) combined with behavioral support (counseling, quitline, or text-message program). |
| Number of EBT Used for Smoking Cessation | 7 months | Self-reported use of the total number of EBT computed by counting the different type of EBTs used for smoking cessation in any combination (range 0 - 4). |
| Text Message (TM) Data Use of Any EBT for Smoking Cessation | 7 months | TM and questionnaire assessment of self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study (for the intervention group, responses were also obtained through text message assessments during the course of the study). EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report 7-day Point Prevalence Smoking Abstinence | 7 months | Participants self-report of no smoking, not even a puff, in the preceding 7 days. |
| Verified 7-day Point Prevalence Smoking Abstinence | 7 months | Participants self-report of no smoking, not even a puff, in the preceding 7 days will be biochemically confirmed through salivary cotinine analysis using the clinically recommended cut off level (\<15 ng/mL = verified abstinent). |
| Motivation to Quit Smoking | 7 months | Self-reported motivation to quit smoking within 30 days. Participants who did not quit smoking (non-abstinent) during the study indicated whether they are ready to quit smoking within 30 days. |
| Any Quit Smoking Attempt | 7 months | Self-reported attempts to quit smoking for at least 24 hours. Participants indicated whether they made any attempt to quit smoking for at least 24 hours because they were trying to quit (not due to illness or hospitalization) |
| Participant's Satisfaction | within 10 days after the dental clinic visit. | A 10-item questionnaire measuring satisfaction with the video experience (6 items) and satisfaction with the virtual reality (VR) headset experience (4 items). Each item is rated on a 1 ("not satisfied at all") to 7 ("very satisfied") scale and average scores are computed for each scale. Higher scores mean a better outcome. |
| EBT Utilization Index Score | up to 7 months | The utilization index score (UIS) is computed as the sum of the utilization dose of each evidence-based treatment (EBT) for smoking cessation used by participants (range 0 - 100). Higher scores mean a better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBelinda Borrelli, PhD
Henry M Goldman School of Dental Medicine
Participant flow
Recruitment details
Recruitment occurred using electronic dental records of dental patients at two university-affiliated dental clinics.
Pre-assignment details
N=695 provided informed consent to participation; n=240 were excluded before randomization (n=63 dental clinic cancelled appointment/changed procedure; n=12 did not opt into the text message program; n=52 did not complete baseline questionnaire; n=58 did not attend the clinic appointment; n=18 rescreened ineligible in-clinic; n=22 no longer interested; n=15 study team cancelled appointment). N=455 randomized; n=15 were ineligible post-randomization (dental provider cancelled/changed procedure)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 124 Participants |
| Region of Enrollment United States | 216 participants |
| Sex/Gender, Customized Female | 101 Participants |
| Sex/Gender, Customized Male | 225 Participants |
| Sex/Gender, Customized Not reported | 0 Participants |
| Sex/Gender, Customized Other | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 216 | 0 / 224 |
| other Total, other adverse events | 0 / 216 | 0 / 224 |
| serious Total, serious adverse events | 0 / 216 | 0 / 224 |
Outcome results
None listed