Nicotine DependenceTiMESNCT03177265
Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
A study testing Text messaging prior to first counseling call, Text-to-Enhance and Mail Notice in people with Nicotine Dependence, run by VA Office of Research and Development at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Text messaging prior to first counseling call, Text-to-Enhance and Mail Notice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2018to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smoker (i.e., positive tobacco use in past 6 months)
- Veteran 18 years or older
- Cell phone number listed the medical record
Who cannot join
- ICD 9 diagnosis of dementia (excluded during data abstraction process)
- Does not speak English
- No mailing address (necessary to mail out initial study materials)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Text messaging prior to first counseling call, Text-to-Enhance, Mail Notice, Telephone Counseling
- Keywords
- nicotine dependence, tobacco cessation
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messaging prior to first counseling callBehavioural
Also called Text to Engage.
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-EnhanceBehavioural
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 NoticeBehavioural
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 CounselingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Text-to-Enhance |
| Telephone Counseling | Active comparator | Telephone counseling condition will receive standard 8 weeks of telephone counseling only. Receives: Behavioral: Telephone Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cotinine-verified quit rate
Tobacco cessation will be verified via oral swab cotinine.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: at completion of recruitment, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start8 Nov 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Krebs, PhD, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177265
- Sponsor's protocol ID
- IIR 15-297
- Acronym
- TiMES
- Status last verified
- Nov 2021
- First submitted
- 31 May 2017
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
- ClinicalTrials.gov ID
- NCT03177265
- Acronym / sponsor ID
- TiMES / IIR 15-297
- Conditions
- Nicotine Dependence
- Keywords
- nicotine dependence, tobacco cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Text to Engage | Experimental | Behavioral: Text messaging prior to first counseling callThis 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. |
| Mail Notice | Other | Behavioral: Mail NoticeThis group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks. |
| Text to Enhance | Experimental | Behavioral: Text-to-EnhanceText-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. |
| Telephone Counseling | Active comparator | Behavioral: Telephone CounselingTelephone counseling condition will receive standard 8 weeks of telephone counseling only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current smoker (i.e., positive tobacco use in past 6 months)
- Veteran 18 years or older
- Cell phone number listed the medical record
Key exclusion criteria (3 listed)
- ICD 9 diagnosis of dementia (excluded during data abstraction process)
- Does not speak English
- No mailing address (necessary to mail out initial study materials)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messaging prior to first counseling callAlso: Text to Engage.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. | Behavioural | Text to Engage |
| Text-to-EnhanceTwo 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. | Behavioural | Text to Enhance |
| Mail NoticeThis 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. | Behavioural | Mail Notice |
| Telephone CounselingTwo 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. | Behavioural | Telephone Counseling |
Primary outcome
cotinine-verified quit rate
Time frame: 12 months
Tobacco cessation will be verified via oral swab cotinine.
1 secondary outcome
Rate of enrollment in telephone counseling
Time frame: at completion of recruitment, average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No. 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.
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Krebs, PhD principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging prior to first counseling call, Text-to-Enhance and Mail Notice in people with Nicotine Dependence, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cotinine-verified quit rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.