Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04020718
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Cessation	Behavioral: Brief telephone advice plus tailored text messages; Drug: Mailed nicotine replacement therapy; Behavioral: Proactive telephone coaching	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Pilot sequential multiple assignment randomized trialPilot sequential multiple assignment randomized trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
• Actual Study Start Date: Jan 31, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early assessment 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.	Behavioral: Brief telephone advice plus tailored text messages; 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.; Drug: Mailed nicotine replacement therapy; 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).; Behavioral: Proactive telephone coaching; 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.
Experimental: Late assessment 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.	Behavioral: Brief telephone advice plus tailored text messages; 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.; Drug: Mailed nicotine replacement therapy; 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).; Behavioral: Proactive telephone coaching; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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

3. 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

4. Self-reported Change in Average Number of Cigarettes Smoked Per Day [12 weeks post-randomization]

   Self-reported change in average cigarettes smoked per day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massacusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Gina R Kruse, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 6, 2020

More Information

Publications

None provided.

• Responsible Party: Gina Kruse, Assistant Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04020718
• Other Study ID Numbers: 2019A005710
• First Posted: Jul 16, 2019
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Gina Kruse, Assistant Professor, Massachusetts General Hospital: mobile health
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Early Assessment	Late Assessment	Early Assessment Non-responders NRT	Early Assessment Non-responders NRT Plus Coaching	Late Assessment Non-responders NRT	Late Assessment Non-responders NRT Plus Coaching	Early Assessment Responders	Late Assessment Responders
Arm/Group Description	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.	Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Individuals reporting past 7 day smoking at 8 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Individuals reporting past 7 day abstinence from cigarettes at 4 weeks post-enrollment, assigned to continue text messages	Individuals reporting past 7 day abstinence from cigarettes at 8 weeks post-enrollment, assigned to continue text messages
Period Title: Pre-assessment and Adaptation
STARTED	16	19	0	0	0	0	0	0
COMPLETED	16	15	0	0	0	0	0	0
NOT COMPLETED	0	4	0	0	0	0	0	0
Period Title: Pre-assessment and Adaptation
STARTED	0	0	8	6	8	7	2	0
COMPLETED	0	0	8	5	8	7	2	0
NOT COMPLETED	0	0	0	1	0	0	0	0

Baseline Characteristics

Arm/Group Title	Early Assessment	Late Assessment	Total
Arm/Group Description	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.	Total of all reporting groups
Overall Participants	16	19	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.8 (12.5)	51.3 (14.2)	53.4 (13.4)
Sex: Female, Male (Count of Participants)
Female	7 43.8%	9 47.4%	16 45.7%
Male	9 56.3%	10 52.6%	19 54.3%
Race/Ethnicity, Customized (Count of Participants)
White, Non-Hispanic	13 81.3%	15 78.9%	28 80%
Hispanic	0 0%	1 5.3%	1 2.9%
arican American, Non-Hispanic	3 18.8%	1 5.3%	4 11.4%
Mixed, Non-Hispanic	0 0%	1 5.3%	1 2.9%
Other, Non-Hispanic	0 0%	1 5.3%	1 2.9%
Time to first cigarette (Count of Participants)
After 60 minutes	1 6.3%	5 26.3%	6 17.1%
31-60 minutes	3 18.8%	3 15.8%	6 17.1%
6-30 minutes	10 62.5%	5 26.3%	15 42.9%
Within 5 minutes	2 12.5%	6 31.6%	8 22.9%
Ready to quit in the next 30 days (Count of Participants)
No, not ready to quit in the next 30 days	3 18.8%	3 15.8%	6 17.1%
Yes, ready to quit in the next 30 days	13 81.3%	16 84.2%	29 82.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
Description	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

Outcome Measure Data

Analysis Population Description

Excluding n=2 withdrawn, n=3 LTFU

Arm/Group Title	Early Assessment Non-responder NRT	Early Assessment Non-responder NRT Plus Coaching	Early Assessment Responder	Late Assessment Non-responder NRT	Late Assessment Non-responder NRT Plus Coaching	Late Assessment Responder
Arm/Group Description	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Measure Participants	8	5	2	8	7	0
0-abstinent	0 0%	1 5.3%	1 2.9%	4 NaN	1 NaN	0 NaN
1-smoking	8 50%	4 21.1%	1 2.9%	4 NaN	6 NaN	0 NaN

2. Secondary Outcome

Title	Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks
Description	7-day point prevalence abstinence (0, abstinent; 1, smoking)
Time Frame	8 weeks post-randomization

Outcome Measure Data

Analysis Population Description

No participants in the late assessment group reported 7 day abstinence (all reported continued smoking) at the 8 week time point.

Arm/Group Title	Early Assessment Non-responder NRT	Early Assessment Non-responder NRT Plus Coaching	Early Assessment Responder	Late Assessment Non-responder NRT	Late Assessment Non-responder NRT Plus Coaching	Late Assessment Responder
Arm/Group Description	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continued text messages.	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continued text messages
Measure Participants	8	5	2	8	7	0
0-abstinent	0 0%	1 5.3%	2 5.7%	0 NaN	0 NaN	0 NaN
1-smoking	8 50%	5 26.3%	2 5.7%	8 NaN	7 NaN	0 NaN

3. Secondary Outcome

Title	Exhaled Carbon Monoxide Less Than 8 Parts Per Million
Description	Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment
Time Frame	12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

There were no participants in the late assessment group who reported 7 day abstinence at the 8 week assessment.

Arm/Group Title	Early Assessment Non-responder NRT	Early Assessment Non-responder NRT Plus Coaching	Early Assessment Responder	Late Assessment Non-responder NRT	Late Assessment Non-responder NRT Plus Coaching	Late Assessment Responder
Arm/Group Description	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continued text messages.	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Measure Participants	8	5	2	8	7	0
0-no biochemically verified abstinence	8 50%	4 21.1%	1 2.9%	5 NaN	6 NaN	0 NaN
1-biochemically verified abstinence	0 0%	1 5.3%	1 2.9%	3 NaN	1 NaN	0 NaN

4. Secondary Outcome

Title	Self-reported Number of Days Nicotine Lozenge and/or Patch Used
Description	Number of days when patch and/or lozenge was used
Time Frame	12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

Analysis compares those randomized to NRT in the second period with those randomized to NRT plus coaching in the second period, pooling early and late assessment arms together for this analysis. Excludes n=2 withdrawn, n=2 quit before second randomization, and n=2 LTFU before second randomization

Arm/Group Title	Mailed 4-week Supply of Combination NRT	Mailed 4-week Supply of Combination NRT Plus Proactive Telephone Coaching
Arm/Group Description	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.	Participants 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. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.
Measure Participants	16	13
Mean (Standard Deviation) [Days]	5.8 (2.4)	7.0 (0.0)

5. Secondary Outcome

Title	Self-reported Change in Average Number of Cigarettes Smoked Per Day
Description	Self-reported change in average cigarettes smoked per day
Time Frame	12 weeks post-randomization

Outcome Measure Data

Analysis Population Description

No participants randomized to late assessment reported 7 day abstinence at 8 weeks post-enrollment.

Arm/Group Title	Early Assessment Non-responder NRT	Early Assessment Non-responder NRT Plus Coaching	Early Assessment Responder	Late Assessment Non-responder NRT	Late Assessment Non-responder NRT Plus Coaching	Late Assessment Responder
Arm/Group Description	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Measure Participants	8	5	2	8	7	0
Mean (Standard Deviation) [Cigarettes per day]	-7.0 (7.3)	-7.2 (7.7)	-13.0 (9.9)	-12.5 (9.3)	-4.7 (7.3)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Early Assessment Non-responder NRT		Early Assessment Non-responder NRT Plus Coaching		Early Assessment Responder		Late Assessment Non-responder NRT		Late Assessment Non-responder NRT Plus Coaching
Arm/Group Description	Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.		Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.		Reported 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages.		Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.		Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-enrollment. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: 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. Mailed nicotine replacement therapy: 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. Proactive telephone coaching: 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.
All Cause Mortality
	Early Assessment Non-responder NRT		Early Assessment Non-responder NRT Plus Coaching		Early Assessment Responder		Late Assessment Non-responder NRT		Late Assessment Non-responder NRT Plus Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/5 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)
Serious Adverse Events
	Early Assessment Non-responder NRT		Early Assessment Non-responder NRT Plus Coaching		Early Assessment Responder		Late Assessment Non-responder NRT		Late Assessment Non-responder NRT Plus Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/5 (0%)		0/2 (0%)		0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Early Assessment Non-responder NRT		Early Assessment Non-responder NRT Plus Coaching		Early Assessment Responder		Late Assessment Non-responder NRT		Late Assessment Non-responder NRT Plus Coaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		2/5 (40%)		0/2 (0%)		1/8 (12.5%)		1/7 (14.3%)
Gastrointestinal disorders
nausea	0/8 (0%)	0	1/5 (20%)	1	0/2 (0%)	0	1/8 (12.5%)	1	0/7 (0%)	0
Hiccup	0/8 (0%)	0	0/5 (0%)	0	0/2 (0%)	0	0/8 (0%)	0	1/7 (14.3%)	1
indigestion	0/8 (0%)	0	1/5 (20%)	1	0/2 (0%)	0	0/8 (0%)	0	0/7 (0%)	0
Psychiatric disorders
anxiety	0/8 (0%)	0	1/5 (20%)	1	0/2 (0%)	0	0/8 (0%)	0	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.