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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation Counselling
• Intervention / Treatment: Behavioral: Free Help; Behavioral: Free Nicotine message; Behavioral: Spanish: Free help message; Behavioral: Spanish: Free nicotine message

Detailed Description

Participants were patients of Los Angeles County Department of Health Services (LADHS). Through the LADHS population health team, eligible patients were identified through data extraction from the electronic health record for quality metric reporting.

Participants were stratified by language (English, Spanish) by LADHS, then randomly assigned to one of two groups. The randomization assignment was generated by a statistician from Kick It California, and text messages were assigned to groups and delivered by LADHS.

Group 1 received a text message offering free quitline coaching. Group 2 received a text message offering free nicotine patches. The texts were sent April-May 2022 and were in English or Spanish according to patient preference. All messages contained a toll-free number to access services, which could be called directly from the text message link, but for tracking purposes different numbers were used.

The quitline, Kick It California, offered coaching to all enrolled participants. The quitline also mailed a 2-week supply of nicotine patches to all enrolled participants unless contraindicated, regardless of which text offer they received. To ensure equitable access, a second text was sent to all participants in June 2022 offering free NRT.

• Study Type: Interventional
• Enrollment (Actual): 4171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Kick It California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient of Los Angeles County Department of Health Services with clinical encounter in past 12 months
• 18 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

Exclusion Criteria:

- Languages other than English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Free counseling text message; Usual care of free quitline counseling	Behavioral: Free Help; 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.
Active Comparator: Free nicotine patch text message; Medication incentive offer with free quitline counseling	Behavioral: Free Nicotine message; 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.
Placebo Comparator: Spanish Arm: Free counseling text message; Usual care of free quitline counseling	Behavioral: Spanish: Free help message; (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.
Active Comparator: Spanish Arm: Free nicotine patch message; Medication incentive offer with free quitline counseling	Behavioral: Spanish: Free nicotine message; (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of quitline treatment	Proportion of patients (identified as tobacco user who has not received cessation assistance) who called the quitline from a text message and received evidence-based cessation treatments (e.g., quitline coaching, nicotine replacement therapy medication, or both)	1-3 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Tobacco Related Disease Research Program; Los Angeles County Department of Public Health; California Smokers' Helpline; Kick It California
• Investigators: Principal Investigator: Elisa Tong, MD, University of California, Davis

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1301241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data about people who engaged with quitline services may be shared if permitted by the quitline protocol, please contact Kick It California
• IPD Sharing Time Frame: Start date: 8/1/2025, End date: 7/31/2026
• IPD Sharing Access Criteria: People interested to access the IPD and supporting information will need to contact the study investigators and Kick It California
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No