Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Condition: Tobacco Use Cessation
Intervention: Brief telephone advice plus tailored text messages; Mailed nicotine replacement therapy; Proactive telephone coaching
Intervention description: 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).; 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Pilot sequential multiple assignment randomized trial
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mobile health

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.
    

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 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