A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.

INTRODUCTION: Sequential multiple assignment randomized trials (SMART) inform the design of adaptive treatment interventions. We tested the feasibility of a SMART to deliver a stepped-care intervention among primary care patients who smoked daily. METHODS: In a 12-week pilot SMART (NCT04020718), we tested the feasibility of recruiting and retaining (>80 %) participants to an adaptive intervention starting with cessation text messages (SMS). The study randomly assigned participants (R1) to assessment of quit status, the tailoring variable, after either 4 or 8 weeks of SMS. The study offered continued SMS alone to those reporting abstinence. Those reporting smoking were randomized (R2) to SMS + mailed NRT or SMS + NRT + brief telephone coaching. RESULTS: During Jan-March and July-Aug 2020, we enrolled 35 patients (>18 years) from a primary care network in Massachusetts. Two (6 %) of 31 participants reported seven-day point prevalence abstinence at their tailoring variable assessment. The 29 participants who continued to smoke at 4 or 8 weeks were randomized (R2) to SMS + NRT (n = 16) or SMS + NRT + coaching (n = 13). Thirty of 35 participants (86 %) completed 12-weeks; 13 % (2/15) of those in 4-week group and 27 % (4/15) of those in 8-week group had CO < 6 ppm at 12-weeks (p = 0.65). Among 29 participants in R2, one was lost to follow-up, 19 % (3/16) of the SMS + NRT group had CO < 6 ppm vs. 17 % (2/12) of SMS + NRT + coaching (p = 1.00). Treatment satisfaction was high (93 %, 28 of 30 who completed 12-weeks). CONCLUSIONS: A SMART exploring a stepped-care adaptive intervention combining SMS, NRT, and coaching for primary care patients was feasible. Retention and satisfaction were high and quit rates were promising.

A qualitative analysis of nicotine replacement therapy uptake, consistent use, and persistence among primary care patients who smoke.

•Adherence can be broken into three processes: uptake, consistent use, and persistence.•Barriers and facilitators to NRT use vary over the three adherence processes.•Information gaps and negative stories about NRT are common barriers to adherence.•NRT adherence may be improved by addressing patient knowledge and concerns.

Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol.

INTRODUCTION: Most smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care. METHODS: In this single-center pilot randomized trial, eligible smokers in primary care are offered brief advice by phone and randomly assigned to one of four interventions: (1) Brief advice only, (2) text messages targeted to primary care patients and tailored to quit readiness, (3) a 2-week supply of nicotine patches and/or lozenges (NRT), and (4) both text messaging and NRT. Randomization is stratified by practice and intention to quit. The text messages (up to 5/day) encourage those not ready to quit to practice a quit attempt, assist those with a quit date through a quit attempt, and promote NRT use. The 2-week supply of NRT is mailed to patients' homes. RESULTS: Feasibility outcomes include recruitment rates, study retention, and treatment adherence. Clinical outcomes are assessed at 1, 2, 6, and 12-weeks post-enrollment. The primary outcome is ≥1self-reported quit attempt(s). Secondary clinical outcomes include self-reported past 7- and 30-day abstinence, days not smoked, NRT adherence, and exhaled carbon monoxide. CONCLUSIONS: This pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care and will inform full-scale randomized trial planning. TRIAL REGISTRATION: ClinicalTrials.govNCT03174158.