Tobacco Use
Conditions
Keywords
tobacco use, smoking
Brief summary
There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.
Detailed description
There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers in general cite several prominent barriers to delivering evidence-based tobacco cessation care, including insufficient time, lack of training, a perception of low motivation in their patients, and concerns about the sensitivity of tobacco cessation discussions. In addition, a large proportion of patients who begin tobacco cessation treatment do not achieve initial abstinence. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to personalize treatment has the potential to increase patient engagement and proactively address treatment non-response. The proposed randomized controlled trial is a two-arm experimental design to demonstrate the feasibility of a larger trial and the acceptability of the intervention design. Participants (N = 30) will be stratified by clinic and randomized to either 1) the active treatment, which includes personalized cognitive behavioral treatment, personalized smoking cessation pharmacotherapy, and test messaging support; or 2) standard of care Department of Veterans Affairs' Quitline (telehealth intervention including 5 sessions of CBT) plus SmokefreeVET (text-messaging intervention).
Interventions
BEHAVIORALPersonalized Smoking Cessation Facilitation Meetings
Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
DRUGPersonalized Smoking Cessation Pharmacotherapy
Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
BEHAVIORALPersonalized Text Messaging Support
If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
BEHAVIORALSmokefreeVET
Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
BEHAVIORALVA Quitline
Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
OTHEREducation about pharmacotherapy
Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Durham VA patient * willing to complete study procedures * appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months * currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week
Exclusion criteria
* participation in Aim 3 (already received the intervention) * current hospitalization (recent hospitalization is acceptable) * currently not using combustible or smokeless tobacco (vaping only) * acute risk for suicide documented in the medical record * or inability to complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report Post-treatment Satisfaction | Post-treatment 3-month follow-up visit (approximately three months after enrollment) | Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Attendance | Post-treatment, approximately eight weeks after baseline visit | Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group). |
| Therapist-rated Treatment Acceptability in Active Treatment Group | Post-treatment 3-month follow-up visit (approximately three months after enrollment) | The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure. |
| Proportion of Participants Who Completed Treatment in the Active Treatment Group | Post-treatment, approximately eight weeks after baseline visit | The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MESH Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability. | 15 |
| Best Practice Telehealth Group Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | MESH | Best Practice Telehealth Group |
|---|---|---|---|
| Age, Continuous | 59.75 years STANDARD_DEVIATION 10.9 | 57.8 years STANDARD_DEVIATION 11.6 | 61.7 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 15 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 28 Participants | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of Participants Who Report Post-treatment Satisfaction
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.
Time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Population: One control participant withdrew prior to the 3-month-follow-up, resulting in 14 control group participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MESH | Number of Participants Who Report Post-treatment Satisfaction | 15 Participants |
| Best Practice Telehealth Group | Number of Participants Who Report Post-treatment Satisfaction | 10 Participants |
Secondary
Proportion of Participants Who Completed Treatment in the Active Treatment Group
The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.
Time frame: Post-treatment, approximately eight weeks after baseline visit
Population: This outcome was only measured in active treatment recipients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MESH | Proportion of Participants Who Completed Treatment in the Active Treatment Group | 100 Percent pts completing treatment |
Secondary
Therapist-rated Treatment Acceptability in Active Treatment Group
The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.
Time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Population: Therapist-rated treatment acceptability was only measured in the active treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MESH | Therapist-rated Treatment Acceptability in Active Treatment Group | 14 Participants |
Secondary
Treatment Attendance
Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).
Time frame: Post-treatment, approximately eight weeks after baseline visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MESH | Treatment Attendance | 15 Participants |
| Best Practice Telehealth Group | Treatment Attendance | 3 Participants |