Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling

Nicotine Dependence Clinical Trial

— TiMES  

Official title:

Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177265
• Other study ID #: IIR 15-297
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cotinine-verified quit rate	Tobacco cessation will be verified via oral swab cotinine.	12 months
Secondary	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