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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text messaging prior to first counseling call
Text-to-Enhance
Mail Notice
Telephone Counseling
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine dependence, tobacco cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Experimental

Active Comparator

Arm Label

Text to Engage

Mail Notice

Text to Enhance

Telephone Counseling

Arm Description

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.

This group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks.

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.

Telephone counseling condition will receive standard 8 weeks of telephone counseling only.

Outcomes

Primary Outcome Measures

cotinine-verified quit rate
Tobacco cessation will be verified via oral swab cotinine.

Secondary Outcome Measures

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.

Full Information

First Posted
May 31, 2017
Last Updated
November 1, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03177265
Brief Title
Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
Acronym
TiMES
Official Title
Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine dependence, tobacco cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text to Engage
Arm Type
Experimental
Arm Description
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.
Arm Title
Mail Notice
Arm Type
Other
Arm Description
This group will only get a mailing indicating that they will receive a call from a quitline counseling in two weeks.
Arm Title
Text to Enhance
Arm Type
Experimental
Arm Description
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.
Arm Title
Telephone Counseling
Arm Type
Active Comparator
Arm Description
Telephone counseling condition will receive standard 8 weeks of telephone counseling only.
Intervention Type
Behavioral
Intervention Name(s)
Text messaging prior to first counseling call
Other Intervention Name(s)
Text to Engage.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text-to-Enhance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mail Notice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Counseling
Intervention Description
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 Measure Information:
Title
cotinine-verified quit rate
Description
Tobacco cessation will be verified via oral swab cotinine.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of enrollment in telephone counseling
Description
This will be calculated from the number who enroll in counseling divided by 1,800 separately for each study condition.
Time Frame
at completion of recruitment, average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Krebs, PhD
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling

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