Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Phase 4

Completed

Conditions: Tobacco Use Cessation

Interventions: Behavioral: Brief telephone advice plus tailored text messages
Drug: Mailed nicotine replacement therapy
Behavioral: Proactive telephone coaching

Registration Number: NCT04020718

Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Early assessment	Brief telephone advice plus tailored text messages	Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
Early assessment	Mailed nicotine replacement therapy	Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
Early assessment	Proactive telephone coaching	Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
Late assessment	Brief telephone advice plus tailored text messages	Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
Late assessment	Mailed nicotine replacement therapy	Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
Late assessment	Proactive telephone coaching	Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks	12 weeks post-randomization	7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"

Secondary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide Less Than 8 Parts Per Million	12 weeks post-randomization	Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks	8 weeks post-randomization	7-day point prevalence abstinence (0, abstinent; 1, smoking)
Self-reported Change in Average Number of Cigarettes Smoked Per Day	12 weeks post-randomization	Self-reported change in average cigarettes smoked per day
Self-reported Number of Days Nicotine Lozenge and/or Patch Used	12 weeks post-randomization	Number of days when patch and/or lozenge was used