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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Massacusetts General Hospital
Boston, Massachusetts, United States
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"
Time frame: 12 weeks post-randomization
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
7-day point prevalence abstinence (0, abstinent; 1, smoking)
Time frame: 8 weeks post-randomization
Exhaled Carbon Monoxide Less Than 8 Parts Per Million
Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
Time frame: 12 weeks post-randomization
Self-reported Number of Days Nicotine Lozenge and/or Patch Used
Number of days when patch and/or lozenge was used
Time frame: 12 weeks post-randomization
Self-reported Change in Average Number of Cigarettes Smoked Per Day
Self-reported change in average cigarettes smoked per day
Time frame: 12 weeks post-randomization
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