Smoking Cessation
Conditions
Keywords
text messaging
Brief summary
This study is a four arm pilot randomized controlled trial testing the effect of a 12 week text messaging intervention and a mailed nicotine medication intervention, alone and in combination to a control condition consisting of brief behavioral advice and usual care. Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the effect of a text messaging program and mailed nicotine replacement therapy on smoking outcomes and medication use. Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a quit attempt compared to smokers receiving no text messaging. Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy. Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects receiving no text messaging intervention. Hypothesis 4: A text messaging intervention will increase the number of days not smoking compared to subjects receiving no text messaging intervention. Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per day compared to subjects receiving no text messaging intervention.
Detailed description
Background: Fifteen percent of U.S. adults continue to smoke despite the availability of effective smoking cessation treatment and healthcare systems are positioned to address this deficiency. Text messaging is a widespread technology which shows promise as a way to reach smokers and to connect them with treatment. Tobacco cessation support delivered by text message increases abstinence among smokers interested in quitting in community- or school-based settings. This has led to the creation of text messaging programs by the National Cancer Institute, SmokeFreeTXT, and others. However, little is known about the feasibility of delivering smoking cessation support by text message for smokers engaged in healthcare systems. Integrating text messaging programs within healthcare systems has clear advantages. Documentation of smoking status is one of the Meaningful Use standards. This documentation enables healthcare systems to identify their population of smokers and proactively target them with health interventions outside of the busy office visit. Text messaging programs originating from the physicians' practice may also leverage the influence physicians have on smokers' motivation to quit. Text messaging has been used in healthcare systems to effectively improve medication adherence in other conditions. Adherence to smoking cessation medications is at least modestly associated with cessation and measures of adherence to smoking cessation medications suggest overall low adherence to cessation medications outside of clinical trials. Offering free nicotine replacement therapy along with the medication adherence advice in a text messaging intervention will allow us to evaluate of the effect of adherence messages on medication use. Study design A pilot randomized controlled trial of 206 smokers who receive care in Massachusetts General Hospital-affiliated primary care practices will compare the effect of delivering behavioral smoking cessation content with pharmacotherapy support by text message plus nicotine replacement therapy on self-reported quit attempts (intentional non-smoking for ≥24 hours), medication adherence, days not smoked, and smoking abstinence at the end of treatment. Smokers will be identified using the electronic health record, screened by their primary care provider, and proactively contacted by telephone by a clinical research coordinator. Potential subjects will be screened for eligibility by self-report and chart review by the Principal Investigator. Eligible subjects will be stratified by practice and readiness to quit (plan to quit smoking in the next 30 days vs no plan to quit smoking/plan to quit smoking in the next 6 months) and randomized 1:1:1:1 to 4 groups using a variable block randomization. 1. Brief advice (BA): Brief advice to quit smoking and usual care. Rationale: All subjects will receive brief advice from a trained clinical research coordinator. All primary care subjects also have access to guideline-concordant tobacco treatment through usual care with their primary care provider. Their primary care provider can refer them to in-person or telephone counseling and can prescribe medications. 2. Nicotine replacement therapy (NRT): Brief advice + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: In order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. To deliver medication, mailed NRT, like text messaging, reaches patients outside of the busy office visit. Mailed NRT alone has also been shown to increase cessation and may itself be an effective intervention compared to brief advice and usual care. 3. Text messaging (TM): Brief advice + 12 week personalized, tailored text messaging program. Rationale: Text messaging shows promise as an intervention to help smokers to quit. However, it has not been well tested among primary care patients. Text messaging may connect those primary care smokers who do not access currently available treatment services like telephone counseling or prescribed medication with assistance outside of the clinic office. 4. Text messaging and nicotine replacement therapy (TM+NRT): Brief advice + 12 week personalized, tailored text messaging program + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: As above, in order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. Text messaging has been shown to increase medication adherence in other conditions and medication adherence is suboptimal among users of smoking cessation medications. Integrating text messaging within healthcare systems offers opportunities to coordinate with pharmacotherapy and this 4 group design allows us to test the effect of text messaging alone on smoking outcomes and the effect of text messaging on NRT use.
Interventions
Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
BEHAVIORALText messaging
12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
BEHAVIORALBrief advice
Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4 arm randomized controlled 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, QuitWorks 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 affecting ability to consent * Willing and able to receive and participate with a text message program for up to 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempts | End of treatment (12 week post-enrollment) | Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more (During the past 12 weeks, have you quit smoking intentionally for 1 day or longer). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cigarettes Per Day | 12 weeks post enrollment (end of treatment) | Self-reported number of cigarettes per day on days smoked, change |
| Milligrams of Nicotine Medication Used | week 2 post enrollment | Self-reported milligrams of nicotine medication used |
| Percentage of Days Not Smoked | 12 weeks post-enrollment (end of treatment) | Self-reported, In the past 30 days, how many days did you have at least one cigarette? |
| 7 Day Point Prevalent Abstinence | 6 weeks post-enrollment | Self-reported abstinence Have you smoked, even a puff, in the past 7 days? |
| Days Nicotine Medication Used | Total reported over 2 weeks post-enrollment | Self-reported number of days nicotine lozenge and/or patch used |
| Milligrams Nicotine Medication Used | Total reported over 1 week post-enrollment | Self-reported number of milligrams nicotine medication used |
| Exhaled Carbon Monoxide | 12 weeks post-enrollment (end of treatment) | Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Advice Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training | 39 |
| Text Messaging Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 39 |
| Mailed Nicotine Replacement Therapy Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 36 |
| Text Messaging + Mailed NRT Mailed nicotine replacement therapy: Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of lozenges.
Text messaging: 12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
Brief advice: Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist training | 39 |
| Total | 153 |
Baseline characteristics
| Characteristic | Brief Advice | Text Messaging | Mailed Nicotine Replacement Therapy | Text Messaging + Mailed NRT | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 10.8 | 54.0 years STANDARD_DEVIATION 12.5 | 52.6 years STANDARD_DEVIATION 9.1 | 51.5 years STANDARD_DEVIATION 11.1 | 53.0 years STANDARD_DEVIATION 10.9 |
| Cigarettes per day | 15.5 cigarettes per day STANDARD_DEVIATION 7.1 | 13.6 cigarettes per day STANDARD_DEVIATION 7.7 | 16.6 cigarettes per day STANDARD_DEVIATION 6.8 | 15.4 cigarettes per day STANDARD_DEVIATION 6.5 | 15.3 cigarettes per day STANDARD_DEVIATION 7.1 |
| Race/Ethnicity, Customized Black, non-Hispanic | 2 Participants | 3 Participants | 8 Participants | 4 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 5 Participants | 1 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Mixed race | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 34 Participants | 27 Participants | 24 Participants | 31 Participants | 116 Participants |
| Region of Enrollment United States | 39 participants | 39 participants | 36 participants | 39 participants | 153 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 23 Participants | 21 Participants | 87 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 13 Participants | 18 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 36 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 | 14 / 36 | 7 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 36 | 0 / 39 |
Outcome results
Primary
Quit Attempts
Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more (During the past 12 weeks, have you quit smoking intentionally for 1 day or longer).
Time frame: End of treatment (12 week post-enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Advice | Quit Attempts | 26 Participants |
| Text Messaging | Quit Attempts | 33 Participants |
| Mailed Nicotine Replacement Therapy | Quit Attempts | 29 Participants |
| Text Messaging + Mailed NRT | Quit Attempts | 31 Participants |
p-value: 0.07Chi-squared
p-value: 0.18Chi-squared
p-value: 0.21Chi-squared
Secondary
7 Day Point Prevalent Abstinence
Self-reported abstinence Have you smoked, even a puff, in the past 7 days?
Time frame: 6 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Advice | 7 Day Point Prevalent Abstinence | 4 Participants |
| Text Messaging | 7 Day Point Prevalent Abstinence | 7 Participants |
| Mailed Nicotine Replacement Therapy | 7 Day Point Prevalent Abstinence | 7 Participants |
| Text Messaging + Mailed NRT | 7 Day Point Prevalent Abstinence | 8 Participants |
Secondary
7 Day Point Prevalent Abstinence
Self-reported abstinence Have you smoked, even a puff, in the past 7 days?
Time frame: 12 weeks post-enrollment (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Advice | 7 Day Point Prevalent Abstinence | 4 Participants |
| Text Messaging | 7 Day Point Prevalent Abstinence | 10 Participants |
| Mailed Nicotine Replacement Therapy | 7 Day Point Prevalent Abstinence | 10 Participants |
| Text Messaging + Mailed NRT | 7 Day Point Prevalent Abstinence | 9 Participants |
Secondary
Change in Cigarettes Per Day
Self-reported number of cigarettes per day on days smoked, change
Time frame: 12 weeks post enrollment (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Advice | Change in Cigarettes Per Day | -9.3 change in cigarettes per day | Standard Deviation 8.3 |
| Text Messaging | Change in Cigarettes Per Day | -8.6 change in cigarettes per day | Standard Deviation 6.7 |
| Mailed Nicotine Replacement Therapy | Change in Cigarettes Per Day | -11.3 change in cigarettes per day | Standard Deviation 7.3 |
| Text Messaging + Mailed NRT | Change in Cigarettes Per Day | -8.9 change in cigarettes per day | Standard Deviation 6.9 |
Secondary
Days Nicotine Medication Used
Self-reported number of days nicotine lozenge and/or patch used
Time frame: Total reported over 2 weeks post-enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Advice | Days Nicotine Medication Used | 5.3 days out of 2 weeks | Standard Deviation 4.4 |
| Text Messaging | Days Nicotine Medication Used | 3.3 days out of 2 weeks | Standard Deviation 4.3 |
Secondary
Exhaled Carbon Monoxide
Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million
Time frame: 12 weeks post-enrollment (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Advice | Exhaled Carbon Monoxide | 1 Participants |
| Text Messaging | Exhaled Carbon Monoxide | 3 Participants |
| Mailed Nicotine Replacement Therapy | Exhaled Carbon Monoxide | 3 Participants |
| Text Messaging + Mailed NRT | Exhaled Carbon Monoxide | 2 Participants |
Secondary
Milligrams Nicotine Medication Used
Self-reported number of milligrams nicotine medication used
Time frame: Total reported over 1 week post-enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Advice | Milligrams Nicotine Medication Used | 33.8 milligrams during week 1 | Standard Deviation 54.8 |
| Text Messaging | Milligrams Nicotine Medication Used | 22.3 milligrams during week 1 | Standard Deviation 45.8 |
Secondary
Milligrams of Nicotine Medication Used
Self-reported milligrams of nicotine medication used
Time frame: week 2 post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Advice | Milligrams of Nicotine Medication Used | 84.2 milligrams during week 2 | Standard Deviation 81.2 |
| Text Messaging | Milligrams of Nicotine Medication Used | 58.0 milligrams during week 2 | Standard Deviation 91.3 |
Secondary
Percentage of Days Not Smoked
Self-reported, In the past 30 days, how many days did you have at least one cigarette?
Time frame: 12 weeks post-enrollment (end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Advice | Percentage of Days Not Smoked | 23.7 percentage of past 30 days | Standard Deviation 32.2 |
| Text Messaging | Percentage of Days Not Smoked | 37.2 percentage of past 30 days | Standard Deviation 32 |
| Mailed Nicotine Replacement Therapy | Percentage of Days Not Smoked | 29.0 percentage of past 30 days | Standard Deviation 32.1 |
| Text Messaging + Mailed NRT | Percentage of Days Not Smoked | 36.1 percentage of past 30 days | Standard Deviation 35.5 |