Pragmatic Trial of Text Messages to Recruit Unassisted Tobacco Users Into Quitline Service
Texting to Recruit Unassisted Tobacco Users at a Large Safety Net Health System Into Quitline Service for a Medicaid Value-based Care Program: Pragmatic Randomized Controlled Trial
1 other identifier
interventional
4,171
1 country
1
Brief Summary
The goal of this pragmatic trial is to compare the effects of text messages on quitline enrollment by patients identified in electronic health records as unassisted tobacco users. The main question it aims to answer is: Do messages offering free counseling or free nicotine patches by text increase quitline enrollment? Researchers will compare if people receiving texts about free nicotine patches will have higher quitline enrollment than texts about free counseling. Participants will receive a text message stratified by quitline language and click on the toll-free number to access quitline services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedDecember 15, 2025
December 1, 2025
1 month
July 28, 2025
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Calls to the quitline
Proportion of patients (identified as a tobacco user who has not received cessation assistance) calling the quitline from the link in the text message
1 month
Secondary Outcomes (1)
Receipt of quitline treatment
1-3 months
Study Arms (4)
Free counseling text message
PLACEBO COMPARATORUsual care of free quitline counseling
Free nicotine patch text message
ACTIVE COMPARATORMedication incentive offer with free quitline counseling
Spanish Arm: Free counseling text message
PLACEBO COMPARATORUsual care of free quitline counseling
Spanish Arm: Free nicotine patch message
ACTIVE COMPARATORMedication incentive offer with free quitline counseling
Interventions
Text message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX.
Text message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX.
(Spanish translation available as only English text can be published online in clincialtrials.gov): Text message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX.
(Spanish translation available as only English text can be published online in clinicaltrials.gov): Text message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX.
Eligibility Criteria
You may qualify if:
- Patient of Los Angeles County Department of Health Services with clinical encounter in past 12 months
- years or older
- English or Spanish language
- Had cell phone
- Permission to text
- Patient identified as tobacco user with no documented assistance (e.g., smoking cessation medication, quitline referral, brief counseling by provider) in the prior 24 months
You may not qualify if:
- \- Languages other than English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Kick It Californiacollaborator
- Los Angeles County Department of Public Healthcollaborator
- Tobacco Related Disease Research Programcollaborator
- California Smokers' Helplinecollaborator
Study Sites (1)
Kick It California
San Diego, California, 92093, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Elisa Tong, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
April 1, 2022
Primary Completion
May 1, 2022
Study Completion
August 31, 2022
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Start date: 8/1/2025, End date: 7/31/2026
- Access Criteria
- People interested to access the IPD and supporting information will need to contact the study investigators and Kick It California
Data about people who engaged with quitline services may be shared if permitted by the quitline protocol, please contact Kick It California