A Text Messaging Program for Smokers in Primary Care

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.

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