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

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ClinicalTrials.gov Identifier: NCT03177265
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Text messaging prior to first counseling call Behavioral: Text-to-Enhance Behavioral: Mail Notice Behavioral: Telephone Counseling Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 3600 participants
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
Official Title: Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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 Name: Text to Engage.

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.




Primary Outcome Measures :
  1. cotinine-verified quit rate [ Time Frame: 12 months ]
    Tobacco cessation will be verified via oral swab cotinine.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177265


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

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA Not yet recruiting
San Diego, California, United States, 92161
Contact: Paul Krebs, PhD    619-497-8411    paul.krebs@va.gov   
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Recruiting
New York, New York, United States, 10010
Contact: Romaine Johnson    718-439-4355    Romaine.Johnson@va.gov   
Contact: John G Hay, MD    (212) 686-7500 ext 3860    john.hay@va.gov   
Principal Investigator: Paul Krebs, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Paul Krebs, PhD Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03177265     History of Changes
Other Study ID Numbers: IIR 15-297
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
nicotine dependence
tobacco cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders