Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling

NCT03177265 | Completed DMC

• 1 other identifier: IIR 15-297
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 2

Brief Summary

Tobacco-related diseases account for a significant portion of all VA healthcare costs and are a detriment to the health and quality of life of our Veterans. Despite progress in instituting tobacco screenings and treatment referral, most Veterans still do not receive the most effective strategy to help them quit smoking - pharmacotherapy combined with behavioral coaching. This study builds on findings from population health and mobile interventions to help more Veterans receive evidence-based tobacco treatment. The investigators propose to test the effect of two types of text messaging in combination with telephone cessation counseling: 1) pre-counseling text messages to increase enrollment in counseling, and 2) ongoing texts for those who start counseling that provide appointment reminders and support between sessions to increase adherence to counseling. This study supports multiple goals of the VA's Blueprint for Excellence. Results will directly inform decision-making and population-based care models for tobacco treatment.

Conditions

Nicotine Dependence

Keywords

nicotine dependence; tobacco cessation

Outcome Measures

Primary Outcomes (1)

• cotinine-verified quit rate

  Tobacco cessation will be verified via oral swab cotinine.

  12 months

Secondary Outcomes (1)

• Rate of enrollment in telephone counseling

  at completion of recruitment, average of 1 year

Study Arms (4)

Text to Engage

EXPERIMENTAL

This group will get 8 text messages that target common misperceptions around quitting and use of quit services prior to receiving the first counseling phone call.

Behavioral: Text messaging prior to first counseling call

Mail Notice

OTHER

This group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks.

Behavioral: Mail Notice

Text to Enhance

EXPERIMENTAL

Text-to-Enhance condition will receive SMS appointment reminders for telephone counseling appointments and 5 texts per week with tips and suggestions for quitting for a duration of 8 weeks.

Behavioral: Text-to-Enhance

Telephone Counseling

ACTIVE COMPARATOR

Telephone counseling condition will receive standard 8 weeks of telephone counseling only.

Behavioral: Telephone Counseling

Interventions

Text messaging prior to first counseling call BEHAVIORAL

This is the first randomization (text to engage vs. mailed notice). Patients randomized to this condition will receive up to 8 text messages prior to the first counseling phone call to provide education regarding cessation treatment.

Also known as: Text to Engage.

Text to Engage

Text-to-Enhance BEHAVIORAL

Two weeks following receipt of the letter (PrO condition) or upon completion of the engagement text messages (Text-to-Engage condition) a counselor trained in motivational interviewing and smoking cessation treatment will phone participants. The Text-to-Enhance condition will receive SMS appointment reminders for telephone counseling appointments and 5 texts per week with tips and suggestions for quitting for a duration of 8 weeks. The telephone counseling condition will receive standard 8 weeks of telephone counseling only.

Text to Enhance

Mail Notice BEHAVIORAL

This is the first randomization (text to engage vs. mailed notice). Patients randomized to this condition will receive a notice in the mail that they will receive a phone call in about 2 weeks to offer telephone cessation treatment.

Mail Notice

Telephone Counseling BEHAVIORAL

Two weeks following receipt of the mailed notice or upon completion of the engagement text messages (Text-to-Engage condition) a counselor trained in motivational interviewing and smoking cessation treatment will phone participants. The Text-to-Enhance condition will receive SMS appointment reminders for telephone counseling appointments and 5 texts per week with tips and suggestions for quitting for a duration of 8 weeks. The telephone counseling condition will receive standard 8 weeks of telephone counseling only.

Telephone Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current smoker (i.e., positive tobacco use in past 6 months)
• Veteran 18 years or older
• Cell phone number listed the medical record

You may not qualify if:

• ICD 9 diagnosis of dementia (excluded during data abstraction process)
• Does not speak English
• No mailing address (necessary to mail out initial study materials)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Paul Krebs, PhD

  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will first randomize each Veteran, stratified by site, to: a) Text-to-Engage vs. standard Proactive Outreach (PrO). For those who enroll in counseling, the investigators will then randomize them to: b) Text-to-Enhance + Telephone Counseling vs. Telephone Counseling alone (TelC). Primary outcomes will be the rate of enrollment in counseling and cotinine-verified quit rate at 12 months.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 6, 2017
• Study Start: November 8, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)