Clinical trial NCT04020718
Conditions: Tobacco Use Cessation
Keywords: mobile health
Sponsor: Massachusetts General Hospital
Start date: 2020-01-31; Completion date: 2020-11-30
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

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:

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Brief telephone advice plus tailored text messages intervention 2: Mailed nicotine replacement therapy intervention 3: Proactive telephone coaching
Intervention descriptions: intervention 1: 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. intervention 2: 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). intervention 3: 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.

Protocol documents:
Prot_SAP_000.pdf: 
DETAILED PROTOCOL 
TITLE: A Text Messaging Intervention for Smoking Cessation Among Primary Care Patients  
PRINCIPAL INVESTIGATOR: Gina Rae Kruse, MD 
VERSION DATE:  July 6th , 2020 
I. BACKGROUND SIGNIFICANCE  
a. Historical Background  
Smoking is the leading preventable cause of death in the US, responsible for over 
480,000 deaths per year.1,2 Among US smokers, 52% try to quit each year3 but less than one-
third use medication or counseling in their quit attempt.4 Text messaging shows promise as a 
way to assist smokers to quit. Over 90% of Americans own mobile phones5 and 72% of adult 
cell phone owners text.6 Text message interventions for smokers have increased tobacco 
abstinence rates by 36 to 70% compared to non-health related text messages and/or self-help 
materials.7-17 However, most prior studies of text messaging recruited smokers from the 
community who were planning to quit in the next month. There is little prior work evaluating text 
messaging for smokers in healthcare systems. Of the three prior text messaging studies that 
recruited smokers from healthcare settings, all targeted particularly motivated smokers including 
those already enrolled in a tobacco treatment program18, pregnant smokers,19 and patients with 
coronary disease.20 The effectiveness of delivering tobacco cessation assistance by text 
message for the broader population of smokers in primary care, including both those who are 
“ready to quit” now and those “not ready to quit”, is unknown.  
Healthcare systems are well-positioned to promote smoking cessation because 70% of 
smokers visit a physician each year21 and, although physicians often recommend quitting during 
these visits, competing priorities and time constraints prevent them from offering further 
assistance such as referral to counseling or medication.22 To address this treatment gap, new 
chronic disease management models of care delivery are being developed for tobacco users. 
These models supplement clinicians’ efforts during office visits by offering assistance including 
counseling, medication support and care coordination between visits. In these programs, 
smokers in a healthcare system are identified using the electronic health record (EHR).23 The 
program then reaches out to smokers independent of office visits to offer them help to quit. Prior 
studies of chronic disease management models for tobacco have used mailings and telephone 
calls between visits to engage smokers in tobacco cessation treatment. These studies reported 
an increase in use of treatment and tobacco abstinence.24-30 However, at a health system level, 
repeated mailings or phone calls are costly. Text messaging may be a less costly way to reach 
out to help smokers. Outreach by text message may also overcome barriers27,31 faced by low 
socioeconomic status (SES) smokers who have well-documented disparities in receipt of 
treatment.4,32,33  
Text messaging has been used in healthcare systems to promote medication adherence in 
other conditions including HIV, cardiac disease, mental illness, and for family planning.34-37 
Adherence to smoking cessation medications is at least modestly associated with cessation38-41 
and measures of adherence to smoking cessation medications suggest overall low adherence, 
both in terms of medication execution (total dose of medication) and persistence (duration of 
use) of medication use outside of clinical trials.42-47 Offering nicotine replacement therapy along 
with the medication adherence advice in the text messaging intervention will allow us to 
evaluate of the effect of adherence messages on medication use. Little work has been done to 
explore whether text messaging can effectively promote smoking cessation medication 
adherence in primary care.  


Chronic disease models also allow health systems to reach out to all smokers, not just those 
who are seeking treatment and ready to quit. In the US, 80% of smokers are “not ready to quit” 
in the next 30 days.48 From a public health standpoint, an effective intervention for this group 
may have an even greater impact than programs targeting the minority of smokers who are 
ready to quit.49 Furthermore, few evidence-based treatments are available to help “not ready to 
quit” smokers.21,50,51 
b. Preliminary work supporting the proposed study 
In prior work, I developed a text message program called the getReady2Quit program (R2Q) 
and pilot-tested its feasibility among CHC patients. We recruited smokers at MGH Revere and 
Charlestown using a proactive recruitment process which consisted of sending a letter from the 
subject’s PCP notifying them of the study, followed by a single text message invitation to opt-in 
to R2Q. Among 1,603 smokers, 1,279 (80%) had a mobile number in the EHR and 949 were 
approved by their PCP for the study. 9% (88 of 949) of smokers opted in to R2Q following the 
letter and single recruitment text and this included both ready to quit (68%) and not ready to quit 
smokers (32%). The R2Q pilot model had two components. Part 1 targeted smokers who were 
ready to quit in the next 30 days by proactively recruiting them to a text message program with 
content to support them through a quit attempt. Part 2 targeted smokers who were not ready to 
quit. They were sent novel motivational messages and advice to try a ‘Practice Quit Attempt’. 
This work demonstrated the feasibility of delivering a text messaging program to primary care 
patients. Subjects in the feasibility study are being recruited to participate in an audiotaped 
qualitative interviews to further improve the program design and content prior to the current trial. 
c. Study rationale 
The data summarized above demonstrate several issues that motivate the current study: 
1) despite the availability of effective treatments, primary are patients who smoke rarely use 
assistance when they try to quit, 2) text messaging interventions have been effective in helping 
smokers to quit in the community or school-based settings but have not been well studied in 
clinical populations, 3) text messaging has been used to promote medication adherence in other 
conditions and medication adherence is sub-optimal among smokers and 3) few treatments are 
available for smokers who are not ready to quit and mobile health interventions may be a way to 
nudge these smokers to act.  These observations suggest a need for new interventions that 
reach primary care smokers outside of the busy office visit using a convenient low-cost 
communication modality. 
To further understand how to optimally use text messages for smokers in primary care, we will 
establish the feasibility of a sequential multiple assignment randomized trial (SMART) 
comparing different timing for assessing response to text messages and different treatment 
intensifications for smokers who fail to quit with text messages alone. 
3) A pilot SMART will ascertain the feasibility of conducting a larger SMART to understand when 
smokers should be contacted about response to the text messages and whether treatment 
intensification should include medications or medications plus telephone coaching. 
 
Research Aim: To assess the feasibility of a sequential multiple assignment randomized trial 
(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 and to understand primary care patients’ experiences with the text message 
intervention and the adaptive treatment sequence and timing. 
 
Daily smoker 
enrolled in 
GetReady2Quit 
text message 
intervention
Assess 
smoking 
status at 4 
weeks
Assess 
smoking 
status at 8 
weeks
R1
7-day self 
reported 
abstinence
Not 
abstinent
7-day self 
reported 
abstinence
Not 
abstinent
Continue text 
messages
NRT
NRT+ Tobacco 
coach
Continue text 
messages
NRT
NRT + Tobacco 
coach
R2
R2
12-week outcome assessment and 
Qualitative exit interviews
Figure 1. Pilot SMART schema
NRT=Nicotine replacement therapy
 
 
This is a pilot Sequential multiple assignment randomized trial (SMART) among 35 
smokers who are patients at Massachusetts General Hospital and who receive primary care 
from a Partners primary care provider. 
Patients will be proactively recruited from MGH primary care practices. Patients will also 
be recruited from online advertisements on the Partners Clinical Trials website and from among 
MGH primary care patients who consent to participate in Research Offers Direct to You. We will 
recruit both smokers who are ready to quit smoking in the next 30 days and those who are not 
planning to quit in the next 30 days. 
 
Smokers will be offered a choice of lozenges and/ or patches if they are medically 
eligible and have not quit at their allocated assessment timepoint. 
 
The research coordinator will not be blinded to treatment assignment because he/she 
will register subjects in the text message program during the enrollment telephone call to verify 
receipt of an enrollment confirmation text message (“Hi [First name] Welcome to getReady2Quit 
(R2Q). Your messages and ratings will start soon. Reply STOP to quit, HELP for info. 
Msg&DataRatesMayApply”). Randomization will be done by a computer-generated random 
sequence at time of enrollment and again at time of assessment (4- vs. 8-weeks). The second 
computer generated random sequence is used among patients reporting continue smoking at 4- 
or 8-weeks. 
Those who consent and enroll will be enrolled in our tailored text message program: 
• 
Text messaging (TM):  Brief advice + 12-week personalized, tailored text messaging 
program. 
o 
Rationale: We use the same text message intervention tested in aim 1. Text messaging 
shows promise as an intervention to help smokers to quit. However, it has not been well 
tested among primary care patients and it is not understood how it should be optimally 
combined with other smoking cessation treatments. It has potential to engage primary care 


smokers who do not access currently available treatment services like telephone counseling 
or prescribed medication with assistance outside of the clinic office.  
 
Enrolled patients will also be randomly assigned at baseline to early or late assessment of response 
to text messages: 
 
• 
Early Assessment: After 4 weeks of text messages, Early Assessment smokers are asked at week 4 
about cigarette use in the past 7 days by text message, email or telephone.   
 
• 
Late Assessment:  After 8 weeks of text messages, Late Assessment smokers are asked at week 8 
about cigarette use in the past 7 days by text message, email or telephone.   
o 
Rationale: In order to test the timepoint at which additional support should be offered to text 
message users, we need to compare groups who are assessed for response (i.e. smoking 
cessation) at different time points.   
Patients who report continued smoking defined as cigarette use in the past 7 days at the early 
or late assessment will be randomized to one of two interventions: 
• 
Nicotine replacement therapy (NRT):  4 weeks of nicotine patches or lozenges mailed to subject 
 
• 
NRT and proactive telephone coaching:  4 weeks of nicotine patches or lozenges mailed to subject 
and proactive telephone coaching for smoking cessation. 
o 
Rationale: For non-responders in an adaptive treatment model it is not clear whether 
treatment should be intensified by adding mailed medication to the behavioral text messages 
or if patients who fail to respond (continue to smoke) need more help with both medications, 
text messages and telephone coaching. To deliver medication, mailed NRT and telephone 
coaching reaches patients outside of the busy office visit. 
After verbal consent and screening by the RC. Randomized enrollees will be asked to complete 
a baseline telephone survey. After completion of the baseline survey, participants will be mailed 
a $20 gift card. 
Following the telephone survey, smokers will have their mobile numbers, and first names 
entered into the web-based messaging platform. The program will be tailored to readiness to 
quit and user-entered quit date and personalized with individual’s first name. 
Participants randomized to NRT or telephone counseling + NRT arms will be offered nicotine 
patches or nicotine lozenges in a four-week allotment. Patches will be dosed according to 
reported cigarette consumption per day and lozenges will be dosed according to time to first 
cigarette as per package instructions. Smokers with a previous allergy to skin adhesives with an 
unknown tolerance of or known intolerance to nicotine patches will only be offered lozenges if 
randomized to the NRT or telephone counseling + NRT arms. The prescriptions will be sent by 
mail by study staff to the patient.  
Subjects randomized to the NRT or NRT + coaching arms will be offered nicotine 
replacement therapy dosed per package instructions. Smokers will be offered nicotine patches 
(14 or 21 mg patches) or lozenges (2 or 4 mg lozenges). Smokers who smoke ≥10 cigarettes 
per day will be offered 21 mg patches, those who smoke <10 cigarettes per day will be offered 
14 mg patches. Daily smokers who smoke within 30 minutes of awakening will be also offered 
the 4 mg lozenges. Daily smokers who smoke >30 minutes of awakening will be offered 2 mg 
lozenges. Daily smokers with a prior reaction to adhesives from bandaids or the nicotine patch 
will be offered lozenges only. 
All study subjects will be asked about adverse reactions to the nicotine patch or lozenge 
at all surveys after they are sent medication, at week 8 and week 12 if they are in the 
early assessment group or at week 12 if they are in the late assessment group. 


Baseline assessment:  
Variables obtained from the EHR: 
• 
Demographic factors: age, sex, health insurance (commercial, Medicare, Medicaid, no 
insurance or other), name, and address 
• 
Medical history: coronary heart disease, COPD, diabetes, hypertension, cancer 
• 
Practice characteristics: PCP, practice, number of visits to practice in past year 
Variables obtained from baseline telephone interview:  
• 
Smoking patterns: daily or non-daily, years smoked, Fagerström test for nicotine dependence 
(includes time to first cigarette after waking and cigarettes smoked per day)64, number of 
previous quit attempts defined as any serious quit attempt lasting ≥24 hours 65 ever and in the 
last 12 months, during the past 30 days, on how many days did you have at least one cigarette, 
and do you ever use menthol cigarettes.  
• 
Demographic factors: ethnicity, race (white, black, Native American, Asian, Native Hawaiian or 
other Pacific Islander, other, unknown), and education 
• 
Any prior use of smoking cessation medication (nicotine patch, lozenge, gum, inhaler or nasal 
spray, varenicline, or buproprion) 
• 
Any prior use of behavioral treatment for smoking cessation (clinic or class, in-person 
counseling, telephone counseling, text messaging, alternative therapy, self-help materials, or 
online communities and applications) 
• 
Past month use of other tobacco products-cigars, cigarillos, smokeless tobacco, hookah, or e-
cigarette 
Motivation to quit, confidence to quit, and perceived 2-week distress measured using single-item 
instruments with 11-item likert scale  
• 
Readiness to quit 66 
• 
Measures of psychosocial mechanisms targeted by the text messaging  
• 
PHQ-2 and GAD-2 screening for depression and anxiety 
• 
Single item alcohol67 and substance use disorder68 screening questions and past month illegal 
use of drugs69 
• 
On an average day, about how many text messages do you send and receive on your cell 
phone? 
• 
Cell phone carrier, type (smartphone) and plan details (pay per text or unlimited text 
messaging). 
• 
Email for subjects that want the follow up surveys emailed 
• 
Social security number for payment purposes 
 
Outcome assessments:  
4-week telephone outcome assessment 
 
 
• 
Since starting the study, have you stopped smoking cigarettes for 1 day or longer because you 
were trying to quit smoking? 
o 
If yes→In the past 30 days, how many days did you not smoke cigarettes? 
o 
If yes→On how many of the past 7 days did you have at least one cigarette? 
If 0→Have you smoked cigarettes, even a puff in the past 7 days? 
8-week telephone outcome assessment 
• 
Have you received text messages since last assessment. 
• 
Since starting the study, have you stopped smoking cigarettes for 1 day or longer because you 
were trying to quit smoking? 


o 
If yes→In the past 30 days, how many days did you not smoke cigarettes? 
o 
If yes→On how many of the past 7 days did you have at least one cigarette? 
If No→Have you smoked cigarettes, even a puff in the past 7 days? 
• 
If early assessment and non-responder 
o 
Have you used nicotine patch in the past 7 days? 
o 
How many days in the past week did you use a nicotine patch? 
o 
Have you used nicotine lozenges in the past 7 days?  
o 
How many days in the past 7 days did you use nicotine lozenges?  
o 
On days when you use lozenge, how many do you use on average? 
o 
Have you experienced any side effects in the past 30 days from quit smoking 
medications? 
o 
Have you received a call from a tobacco coach 
12-week telephone outcome assessment 
• 
Have you received text messages since last assessment. 
• 
Since starting the study, have you stopped smoking cigarettes for 1 day or longer because you 
were trying to quit smoking? 
o 
If yes→In the past 30 days, how many days did you not smoke cigarettes? 
o 
If yes→On how many of the past 7 days did you have at least one cigarette? 
If No→Have you smoked cigarettes, even a puff in the past 7 days? 
• 
If non-responder 
o 
Have you used nicotine patch in the past 7 days? 
o 
How many days in the past week did you use a nicotine patch? 
o 
Have you used nicotine lozenges in the past 7 days?  
o 
How many days in the past 7 days did you use nicotine lozenges?  
o 
On days when you use lozenge, how many do you use on average? 
o 
Have you experienced any side effects in the past 30 days from quit smoking 
medications? 
o 
Have you received a call from a tobacco coach 
Statistical Analysis 
Uptake will be calculated as proportion of potentially eligible patients reached and randomized. 
Characteristics of patients randomized will be compared with those who declined using t-tests 
and chi-square tests to identify predictors of intervention uptake. Retention will be measured as 
LTFU at 12 week assessment and will be compared across treatment groups to assess non-
differential LTFU. Fidelity will be measured as number of text messages sent divided by the total 
number intended and proportion of patients reached by the coach, proportion of coaching 
sessions completed, and NRT uptake and adherence (days of NRT used). Qualitative interviews 
will be analyzed using Nvivo 11 using a grounded theory approach and the constant 
comparative method74. Two coders will independently code a subset of interviews then compare 
resulting themes. Discrepancies will be discussed and reconciled iteratively during data 
collection to produce a final coding structure. Intercoder agreement will be measured by kappa 
statistic. 
Sample size 
This sample size is based on having enough patients in all six treatment subgroups (see Figure 
1) to assess the feasibility of a larger-scale SMART. With 30 patients randomized 1:1 in R1 and 
20% response, we expect 3 patients in the smallest subgroup. However, using a method by 
Almirall et al., the probability of reaching this minimum subgroup size by randomization is only 
59%, therefore we will randomize 35 patients to have a 70% probability of at least 3 patients per 
subgroup73.  We anticipate screening up to 90 patients to reach our target randomization of 35 
patients. 


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