Clinical trial NCT03174158: A Text Messaging Program for Smokers in Primary Care
Official title: A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: text messaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-02
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arm randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quit Attempts
timeFrame: End of treatment (12 week post-enrollment)
Secondary outcomes:
measure: 7 Day Point Prevalent Abstinence
timeFrame: 6 weeks post-enrollment
measure: 7 Day Point Prevalent Abstinence
timeFrame: 12 weeks post-enrollment (end of treatment)
measure: Milligrams of Nicotine Medication Used
timeFrame: week 2 post enrollment
measure: Percentage of Days Not Smoked
timeFrame: 12 weeks post-enrollment (end of treatment)
measure: Exhaled Carbon Monoxide
timeFrame: 12 weeks post-enrollment (end of treatment)
measure: Days Nicotine Medication Used
timeFrame: Total reported over 2 weeks post-enrollment
measure: Milligrams Nicotine Medication Used
timeFrame: Total reported over 1 week post-enrollment
measure: Change in Cigarettes Per Day
timeFrame: 12 weeks post enrollment (end of treatment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massacusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gina R Kruse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruse GR, Park ER, Chang Y, Haberer JE, Abroms LC, Shahid NN, Howard S, Haas JS, Rigotti NA. Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1509-1514. doi: 10.1093/ntr/ntaa050.
citation: Kruse GR, Park E, Haberer JE, Abroms L, Shahid NN, Howard SE, Chang Y, Haas JS, Rigotti NA. Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol. Contemp Clin Trials. 2019 May;80:48-54. doi: 10.1016/j.cct.2019.03.006. Epub 2019 Mar 25.