Tobacco Use Cessation
Conditions
Keywords
mobile health
Brief summary
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
Interventions
BEHAVIORALBrief telephone advice plus tailored text messages
All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.
Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).
BEHAVIORALProactive telephone coaching
Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot sequential multiple assignment randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) * Smoking status of current smoker in structured field of electronic health record (EHR) * Language listed as English in EHR * Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP) * PCP visit in the past 2 years * Mobile telephone number listed in EHR
Exclusion criteria
* Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking * Pregnant, planning to become pregnant in the next 3 months, or breastfeeding. * Past 30-day use of nicotine replacement therapy, bupropion, or varenicline. * Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs * Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation * Ever had an allergy to nicotine patch * Weight \< 100 pounds * Unstable coronary disease * Unstable arrhythmia * Dementia or active psychosis or schizoaffective disorder * Willing and able to receive and participate with a text message program for up to 12 weeks * Unable to read English or unable to write English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 12 weeks post-randomization | 7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as Have you smoked cigarettes, even a puff, in the past seven days? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 8 weeks post-randomization | 7-day point prevalence abstinence (0, abstinent; 1, smoking) |
| Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 12 weeks post-randomization | Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment |
| Self-reported Number of Days Nicotine Lozenge and/or Patch Used | 12 weeks post-randomization | Number of days when patch and/or lozenge was used |
| Self-reported Change in Average Number of Cigarettes Smoked Per Day | 12 weeks post-randomization | Self-reported change in average cigarettes smoked per day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Assessment Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching.
Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.
Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.
Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities. | 16 |
| Late Assessment Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching.
Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit.
Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions.
Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities. | 19 |
| Total | 35 |
Baseline characteristics
| Characteristic | Late Assessment | Total | Early Assessment |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 14.2 | 53.4 years STANDARD_DEVIATION 13.4 | 55.8 years STANDARD_DEVIATION 12.5 |
| Race/Ethnicity, Customized arican American, Non-Hispanic | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed, Non-Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other, Non-Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 15 Participants | 28 Participants | 13 Participants |
| Ready to quit in the next 30 days No, not ready to quit in the next 30 days | 3 Participants | 6 Participants | 3 Participants |
| Ready to quit in the next 30 days Yes, ready to quit in the next 30 days | 16 Participants | 29 Participants | 13 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 19 Participants | 9 Participants |
| Time to first cigarette 31-60 minutes | 3 Participants | 6 Participants | 3 Participants |
| Time to first cigarette 6-30 minutes | 5 Participants | 15 Participants | 10 Participants |
| Time to first cigarette After 60 minutes | 5 Participants | 6 Participants | 1 Participants |
| Time to first cigarette Within 5 minutes | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 5 | 0 / 2 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 2 / 5 | 0 / 2 | 1 / 8 | 1 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 5 | 0 / 2 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as Have you smoked cigarettes, even a puff, in the past seven days?
Time frame: 12 weeks post-randomization
Population: Excluding n=2 withdrawn, n=3 LTFU
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 0 Participants |
| Early Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 8 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 1 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 4 Participants |
| Early Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 1 Participants |
| Early Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 1 Participants |
| Late Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 4 Participants |
| Late Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 4 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 1 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 6 Participants |
| Late Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 0-abstinent | 0 Participants |
| Late Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks | 1-smoking | 0 Participants |
Secondary
Exhaled Carbon Monoxide Less Than 8 Parts Per Million
Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
Time frame: 12 weeks post-randomization
Population: There were no participants in the late assessment group who reported 7 day abstinence at the 8 week assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Assessment Non-responder NRT | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 0 Participants |
| Early Assessment Non-responder NRT | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 8 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 1 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 4 Participants |
| Early Assessment Responder | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 1 Participants |
| Early Assessment Responder | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 1 Participants |
| Late Assessment Non-responder NRT | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 5 Participants |
| Late Assessment Non-responder NRT | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 3 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 6 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 1 Participants |
| Late Assessment Responder | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 1-biochemically verified abstinence | 0 Participants |
| Late Assessment Responder | Exhaled Carbon Monoxide Less Than 8 Parts Per Million | 0-no biochemically verified abstinence | 0 Participants |
Secondary
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking)
Time frame: 8 weeks post-randomization
Population: No participants in the late assessment group reported 7 day abstinence (all reported continued smoking) at the 8 week time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 8 Participants |
| Early Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 0 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 5 Participants |
| Early Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 1 Participants |
| Early Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 2 Participants |
| Early Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 2 Participants |
| Late Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 8 Participants |
| Late Assessment Non-responder NRT | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 0 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 0 Participants |
| Late Assessment Non-responder NRT Plus Coaching | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 7 Participants |
| Late Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 1-smoking | 0 Participants |
| Late Assessment Responder | Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks | 0-abstinent | 0 Participants |
Secondary
Self-reported Change in Average Number of Cigarettes Smoked Per Day
Self-reported change in average cigarettes smoked per day
Time frame: 12 weeks post-randomization
Population: No participants randomized to late assessment reported 7 day abstinence at 8 weeks post-enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Assessment Non-responder NRT | Self-reported Change in Average Number of Cigarettes Smoked Per Day | -7.0 Cigarettes per day | Standard Deviation 7.3 |
| Early Assessment Non-responder NRT Plus Coaching | Self-reported Change in Average Number of Cigarettes Smoked Per Day | -7.2 Cigarettes per day | Standard Deviation 7.7 |
| Early Assessment Responder | Self-reported Change in Average Number of Cigarettes Smoked Per Day | -13.0 Cigarettes per day | Standard Deviation 9.9 |
| Late Assessment Non-responder NRT | Self-reported Change in Average Number of Cigarettes Smoked Per Day | -12.5 Cigarettes per day | Standard Deviation 9.3 |
| Late Assessment Non-responder NRT Plus Coaching | Self-reported Change in Average Number of Cigarettes Smoked Per Day | -4.7 Cigarettes per day | Standard Deviation 7.3 |
Secondary
Self-reported Number of Days Nicotine Lozenge and/or Patch Used
Number of days when patch and/or lozenge was used
Time frame: 12 weeks post-randomization
Population: Analysis compares those randomized to NRT in the second period with those randomized to NRT plus coaching in the second period, pooling early and late assessment arms together for this analysis. Excludes n=2 withdrawn, n=2 quit before second randomization, and n=2 LTFU before second randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Assessment Non-responder NRT | Self-reported Number of Days Nicotine Lozenge and/or Patch Used | 5.8 Days | Standard Deviation 2.4 |
| Early Assessment Non-responder NRT Plus Coaching | Self-reported Number of Days Nicotine Lozenge and/or Patch Used | 7.0 Days | Standard Deviation 0 |