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

• ClinicalTrials.gov Identifier: NCT03177265
• Recruitment Status: Recruiting
• First Posted: June 6, 2017
• Last Update Posted: July 24, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: May 31, 2017
• First Posted Date: June 6, 2017
• Last Update Posted Date: July 24, 2019
• Actual Study Start Date: October 22, 2018
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 2, 2017)

cotinine-verified quit rate [ Time Frame: 12 months ]

Tobacco cessation will be verified via oral swab cotinine.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03177265 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 2, 2017)

Rate of enrollment in telephone counseling [ Time Frame: at completion of recruitment, average of 1 year ]

This will be calculated from the number who enroll in counseling divided by 1,800 separately for each study condition.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
• Official Title: Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
• 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.
• 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 three VA sites. All identified smokers will be mailed an introductory packet with information about the study. Patients who mail back a 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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.

Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Nicotine Dependence

Intervention

• 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 Name: Text to Engage.
• 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.
• 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.
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Text messaging prior to first counseling call
• Mail Notice
  This group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks.
  Intervention: Behavioral: Mail Notice
• 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.
  Intervention: Behavioral: Text-to-Enhance
• Active Comparator: Telephone Counseling
  Telephone counseling condition will receive standard 8 weeks of telephone counseling only.
  Intervention: Behavioral: Telephone Counseling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 2, 2017): 3600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2020
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Scott E Sherman, MD MPH; (212) 686-7500 ext 7386; Scott.Sherman@va.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03177265
• Other Study ID Numbers: IIR 15-297
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: VA Office of Research and Development
• Study Sponsor: VA Office of Research and Development
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul Krebs, PhD; Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

• PRS Account: VA Office of Research and Development
• Verification Date: July 2019