A Text Messaging Program for Smokers in Primary Care

Study Overview
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Brief Summary
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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
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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. 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. 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. 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. 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.

Official Title
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A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Mailed nicotine replacement therapy
* Behavioral: Text messaging
* Behavioral: Brief advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arm randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief advice<br>Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training. | Behavioral: Brief advice<br>* Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training<br>|
| Experimental: Text messaging<br>Patients randomized to the text messaging program are offered a 12-week text messaging. The text messaging intervention will use content from the National Cancer Institute's SmokeFreeTXT library, content for smokers not ready to quit from SmokeFreeTXT and a pilot feasibility study conducted by the PI, and new messages supporting nicotine replacement medication adherence. The text messaging program will be personalized using subject's first name, the telephone number for the Massachusetts General Hospital (MGH) tobacco cessation counseling services and the Massachusetts state quitline. Smokers receiving the intervention will be sent from 0 and 5 text messages per day. | Behavioral: Text messaging<br>* 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.<br>Behavioral: Brief advice<br>* Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training<br>|
| Experimental: Mailed nicotine replacement therapy<br>Subjects randomized to mailed nicotine replacement therapy will be offered a 2 week supply of nicotine replacement therapy mailed to their home address. Daily smokers planning to quit in the next 30 days will be offered nicotine patches (14 or 21 mg patches) and lozenges (2 or 4 mg lozenges) dosed according to package instructions. Non-daily smokers planning to quit will be offered a 2 week allotment of 2 mg lozenges alone. Smokers not planning to quit will be offered one box of lozenges (72 count box of 4 mg or 2 mg lozenges based on time to first cigarette as above per package instructions) to use when they are not smoking during their practice quit attempt. | Drug: Mailed nicotine replacement therapy<br>* 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.<br>Behavioral: Brief advice<br>* Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training<br>|
| Experimental: Text messaging + mailed NRT<br>Subjects will be offered both the 12 week text message program and 2 weeks of mailed nicotine replacement therapy. | Drug: Mailed nicotine replacement therapy<br>* 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.<br>Behavioral: Text messaging<br>* 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.<br>Behavioral: Brief advice<br>* Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | End of treatment (12 week post-enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 Day Point Prevalent Abstinence | Self-reported abstinence Have you smoked, even a puff, in the past 7 days? | 6 weeks post-enrollment | 
| 7 Day Point Prevalent Abstinence | Self-reported abstinence Have you smoked, even a puff, in the past 7 days? | 12 weeks post-enrollment (end of treatment) | 
| Milligrams of Nicotine Medication Used | Self-reported milligrams of nicotine medication used | week 2 post enrollment | 
| Percentage of Days Not Smoked | Self-reported, In the past 30 days, how many days did you have at least one cigarette? | 12 weeks post-enrollment (end of treatment) | 
| Exhaled Carbon Monoxide | Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million | 12 weeks post-enrollment (end of treatment) | 
| Days Nicotine Medication Used | Self-reported number of days nicotine lozenge and/or patch used | Total reported over 2 weeks post-enrollment | 
| Milligrams Nicotine Medication Used | Self-reported number of milligrams nicotine medication used | Total reported over 1 week post-enrollment | 
| Change in Cigarettes Per Day | Self-reported number of cigarettes per day on days smoked, change | 12 weeks post enrollment (end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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text messaging