Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling (TiMES)

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Text messaging prior to first counseling call; Behavioral: Mail Notice; Behavioral: Text-to-Enhance; Behavioral: Telephone Counseling

Detailed Description

Tobacco use remains the number one cause of premature death and morbidity in the United States, and tobacco-related diseases account for 24% of all VA healthcare costs. The VA has been a leader in addressing tobacco use, having implemented annual tobacco screening and made pharmacotherapy readily available. However, one of the most cost-effective services - telephone quit lines - remain highly underused. Few Veterans enroll in telephone counseling to help them quit smoking, and among Veterans who begin telephone counseling, few complete a full course. The advent of electronic health records (EHRs) has enabled new strategies for ensuring that patients receive preventive services. These methods can reduce provider burden and close gaps in systems of care. The investigators' research team has conducted numerous studies using EHRs to identify smokers and proactively reach out to coordinate telephone tobacco treatment. While the investigators have successfully implemented this approach, the overall enrollment rates for counseling remain low and the majority of smokers complete only one counseling session. Therefore, the investigators propose to test novel mHealth strategies for promoting enrollment in and adherence to telephone counseling. The Specific Aims are to: 1) Conduct a sequentially randomized trail to estimate the effectiveness of text messaging for increasing enrollment in and adherence to telephone tobacco treatment, 2) Compare rates of tobacco cessation between patients who received and did not receive text messaging during treatment, and 3) Evaluate patient experiences with these interventions. Using the VA EHR, the investigators will identify N=3,600 smokers at two VA sites. All identified smokers will be mailed an introductory packet with information about the study. Patients who consent will be randomized to standard telephone outreach for counseling or to receive 8 educational texts to counter barriers of participating in counseling prior to telephone outreach. Patients who enroll in tobacco treatment will then be randomized to receive standard telephone counseling or to also receive appointment reminders and supportive texts throughout the 8-week counseling period. The investigators hypothesize that these approaches will increase the rate of enrollment in telephone tobacco cessation and 12-month biochemically validated abstinence (primary outcomes) over standard telephone counseling approaches. The investigators will also assess patient experiences with each texting protocol. The investigators' overarching goal is to investigative innovative mHealth strategies for increasing Veteran use of telephone-based tobacco cessation counseling and to improve quit rates. This research, exploring both population-based outreach and text messaging, advances multiple goals set forth by the VA's Blueprint for Excellence. Results will have direct implications to inform decision-making and population-based care models for tobacco treatment.

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA
  • New York
    • New York, New York, United States, 10010
      • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text to Engage; 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; 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.; Other Names: Text to Engage.
Other: Mail Notice; This group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks.	Behavioral: Mail Notice; 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.
Experimental: Text to Enhance; 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; 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.
Active Comparator: Telephone Counseling; Telephone counseling condition will receive standard 8 weeks of telephone counseling only.	Behavioral: Telephone Counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cotinine-verified quit rate	Tobacco cessation will be verified via oral swab cotinine.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of enrollment in telephone counseling	This will be calculated from the number who enroll in counseling divided by 1,800 separately for each study condition.	at completion of recruitment, average of 1 year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Paul Krebs, PhD, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: nicotine dependence; tobacco cessation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: IIR 15-297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

We will prepare multiple manuscripts to be submitted to peer-review journals summarizing our findings. We will disseminate our study findings through several additional channels:

• Traditional Dissemination - We will send a study report to each facility's leadership, including the medical center Director and ACOS of Research, for their review. We will also publish findings in relevant journals
• We will submit one or more abstracts to the annual HSR&D meeting as well as other gatherings of health service professionals.
• VA Office of Connected Health - We will share our study findings with the Office of Connected Health in order to provide data regarding potential uses of efficacy of the technologies they are supporting.

Access to data will be made available to any researcher wishing to analyze data with a research protocol approved by the IRB and with a data use agreement approved by the PO and ISO at our facility.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No