Salvation Army Tobacco Quit Line Referral Implementation Trial

September 2, 2026 updated by: University of Wisconsin, Madison

Using a Pragmatic Randomized Rollout Trial to Evaluate Implementation Strategies to Promote Smoking Treatment and Cancer Prevention for Salvation Army Clients

The goal of this clinical trial is to understand how the Salvation Army staff can help people who use tobacco learn about and connect with no-cost treatments to help cut down or quit smoking. Researchers will gather information about the thoughts and experiences of people who smoke tobacco and receive services at the Salvation Army, as well as the experiences of the staff offering support to help treat tobacco use.

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

In this 2-year pilot study, a team of Salvation Army personnel and consumers will work with a member of the University of Wisconsin Center for Tobacco Research and Intervention Regional Outreach team to plan, implement, and evaluate strategies to connect Salvation Army service consumers with the Wisconsin Tobacco Quit Line for help quitting smoking. The study team will pilot test and refine an enhanced implementation support protocol designed to help Salvation Army teams adapt quitline referral workflows and implementation strategies to fit well with the culture and climate of participating Salvation Army sites, and to enhance Salvation Army staff readiness to connect the consumers they serve with the Wisconsin Tobacco Quit Line. The study team will also pilot test and refine a strategy that Salvation Army personnel can use to incentivize acceptance of Wisconsin Tobacco Quit Line connections by consumers while they are at the Salvation Army service center. To evaluate and enhance the 2 implementation strategies of interest in this study (enhanced implementation support for personnel and an incentive for consumers to accept a connection with the Quit Line while at the Salvation Army), the study team will conduct qualitative interviews with both personnel and consumers at Salvation Army sites, and will collect survey data from personnel and consumers. Service records from both the Salvation Army and Wisconsin Tobacco Quit Line will also be collected for this study to help evaluate the reach of the tobacco treatment intervention, and the representativeness of its reach across subpopulations of consumers. Data regarding the process of implementing Wisconsin Tobacco Quit Line referral in the Salvation Army will also be gathered via observation and recordings of project team meetings. These sources of data will be integrated to help evaluate how well the strategies of interest work in 2 Salvation Army sites, and to refine these in preparation for a full-scale cluster-randomized clinical trial.

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.
96

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention

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:

  • Age 18 or older
  • Involved in the management, delivery, or receipt of social services offered by a participating Salvation Army site, or a member of the University of Wisconsin-Center for Tobacco Research and Intervention Outreach Team supporting Wisconsin Tobacco Quit Line implementation
  • Able to speak English, Spanish, or another language for which an interpreter is available

Exclusion Criteria:

  • Children under the age of 18
  • Unable to speak a common language with a study team member or available interpreter

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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.
Experimental: Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support
Both participating sites in this pilot study will be in this experimental enhanced implementation support arm to help us iteratively enhance the feasibility, acceptability, and sustainability of implementation strategies to support WTQL referral in these sites. Salvation Army personnel at participating sites will receive implementation training and ongoing support to help enhance the fit of WTQL referral in their workflows, culture, and climate, and to enhance staff readiness to connect the consumers they serve with the WTQL. No consumer incentives for connecting with the Quit Line immediately by phone will be offered in this arm so it can serve as active comparator condition for the incentivized arm described below.
Behavioral: Cognitive-Motivational Feedback
Salvation Army personnel will be trained to offer adult consumers who use tobacco cognitive-motivational feedback about tobacco use via a no-cost, web-based Qualtrics survey that assesses participant knowledge, beliefs, and priorities and provides feedback to promote knowledge of the costs and risks of smoking and knowledge of the costs and benefits of tobacco use treatment options, including Wisconsin Tobacco Quit Line services. The survey is also designed to help participants weigh the importance of the pros and cons of continuing to use tobacco, and the pros and cons of trying to change their tobacco use.
Behavioral: Staff Tobacco Quit Line Referral Implementation Support
Salvation Army personnel will receive training and will be engaged in efforts to plan, evaluate, adapt, and sustain tobacco treatment referral as part of the social services they provide to adult Salvation Army service consumers who use tobacco. Implementation support will take the form of ongoing engagement of an outreach specialist with a team of Salvation Army personnel and consumers who lead Quit Line referral efforts in the Salvation Army.
Experimental: Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral
In this experimental condition, Salvation Army personnel will implement an incentive strategy designed to encourage Salvation Army consumers to accept immediate referral to the WTQL. The incentive strategy will be adapted by Salvation Army personnel to fit in the local context, and staff will receive training and ongoing support in implementation of the incentive strategy. The modest incentives will be added in a staggered manner across the 2 Salvation Army sites participating in this pilot trial, after at least 3 months of implementing WTQL referral without consumer incentives for immediate calls.
Behavioral: Cognitive-Motivational Feedback
Salvation Army personnel will be trained to offer adult consumers who use tobacco cognitive-motivational feedback about tobacco use via a no-cost, web-based Qualtrics survey that assesses participant knowledge, beliefs, and priorities and provides feedback to promote knowledge of the costs and risks of smoking and knowledge of the costs and benefits of tobacco use treatment options, including Wisconsin Tobacco Quit Line services. The survey is also designed to help participants weigh the importance of the pros and cons of continuing to use tobacco, and the pros and cons of trying to change their tobacco use.
Behavioral: Staff Tobacco Quit Line Referral Implementation Support
Salvation Army personnel will receive training and will be engaged in efforts to plan, evaluate, adapt, and sustain tobacco treatment referral as part of the social services they provide to adult Salvation Army service consumers who use tobacco. Implementation support will take the form of ongoing engagement of an outreach specialist with a team of Salvation Army personnel and consumers who lead Quit Line referral efforts in the Salvation Army.
Behavioral: Consumer Incentives for Immediate Referral to a Tobacco Quit Line
Salvation Army personnel will offer an incentive to adult consumers who use tobacco to encourage immediate acceptance of a live call with the Wisconsin Tobacco Quit Line. The incentive will be designed by Salvation Army personnel to fit the local context and to be sustainable over time, such as extra access to existing support or resources.

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
Wisconsin Tobacco Quit Line (WTQL) referral rate
Time Frame: 18 months
Proportion of adult Salvation Army consumers who use tobacco referred to the WTQL in any modality. Goal is at least 10% without incentives, and at least 16% with incentives.
18 months
Wisconsin Tobacco Quit Line (WTQL) enrollment rate
Time Frame: 18 months
Proportion of clients referred from Salvation Army sites that enroll in WTQL services. Goal is at least 5% without incentives, 8% with incentives.
18 months
Salvation Army personnel WTQL referral training engagement
Time Frame: 18 months
Proportion of eligible Salvation Army personnel who participate in at least some WTQL referral training. Goal is at least 70%.
18 months
Tobacco use screening of adult consumers of Salvation Army services
Time Frame: 18 months
Rate of asking about and documenting current tobacco use among all adult consumers of eligible services in participating Salvation Army sites. Goal is 50% screening rate.
18 months

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
Salvation Army personnel adoption of WTQL referral
Time Frame: 18 months
Proportion of eligible Salvation Army personnel who refer at least 1 client to the WTQL. Goal is at least 60%.
18 months
Self-reported abstinence from smoking in the past 7 days
Time Frame: 3 months, 6 months post target date to quit smoking
Number of WTQL service clients referred from the Salvation Army who report no smoking in the past 7 days at follow-up
3 months, 6 months post target date to quit smoking
Immediate referral via live calls to Wisconsin Tobacco Quit Line (WTQL)
Time Frame: 18 months
Rate of immediate referral via live calls to WTQL among adult Salvation Army consumers who use tobacco (this will be a subset of the primary referral outcome)
18 months
Cost per successful WTQL referral
Time Frame: 18 months
Estimated cost of successfully connecting a Salvation Army consumer with the WTQL, with and without incentives for immediate WTQL connection
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost per successful WTQL referral
Time Frame: 18 months
Estimated cost of successfully connecting a Salvation Army consumer with the WTQL, with and without incentives for immediate WTQL connection
18 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 Wisconsin, Madison

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.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

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: Danielle McCarthy, PhD, University of Wisconsin, Madison

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.
November 1, 2024

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.
June 30, 2026

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, 2026

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).
November 12, 2024

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.
November 12, 2024

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.
November 14, 2024

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.
September 9, 2026

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.
September 2, 2026

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.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2024-0978
  • A534253 (Other Identifier: UW- Madison)
  • UG3CA293756 (U.S. NIH Grant/Contract)
  • Protocol Version 4/28/26 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual-level original data collected in this trial will be shared. Aggregate data on Salvation Army and Wisconsin Tobacco Quit Line data used in analyses for this trial will also be shared.

IPD Sharing Time Frame

By the time of publication of the primary outcome analyses or the end of the performance period, whichever comes sooner, and up to 7 years after publication.

IPD Sharing Access Criteria

IRB approval and meeting restricted use criteria in the data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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