Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

NCT ID: NCT04020718

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-11-30

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.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief telephone advice plus tailored text messages

Intervention Type: BEHAVIORAL

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.

Mailed nicotine replacement therapy

Intervention Type: DRUG

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).

Proactive telephone coaching

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Brief telephone advice plus tailored text messages

Intervention Type: BEHAVIORAL

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.

Mailed nicotine replacement therapy

Intervention Type: DRUG

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).

Proactive telephone coaching

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gina Kruse

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gina R Kruse, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massacusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Kruse GR, Joyce A, Yu L, Park ER, Neil J, Chang Y, Rigotti NA. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke. J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.

Reference Type: DERIVED

PMID: 36880910 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019A005710

Identifier Type: -

Identifier Source: org_study_id