Pragmatic Trial of Text Messages to Recruit Unassisted Tobacco Users Into Quitline Service

December 5, 2025 updated by: Elisa Tong, MD, University of California, Davis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Calls to the quitline
Time Frame: 1 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Receipt of quitline treatment
Time Frame: 1-3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tobacco Related Disease Research Program
Los Angeles County Department of Public Health
California Smokers' Helpline
Kick It California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisa Tong, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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