Salvation Army Tobacco Quit Line Referral Implementation Trial

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: Enrolling by invitation
• Conditions: Smoking; Smoking Cessation; Tobacco Use
• Intervention / Treatment: Behavioral: Cognitive-Motivational Feedback; Behavioral: Staff Tobacco Quit Line Referral Implementation Support; Behavioral: Consumer Incentives for Immediate Referral to a Tobacco Quit Line

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: Interventional
• Enrollment (Estimated): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Wisconsin Tobacco Quit Line (WTQL) referral rate	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Salvation Army personnel adoption of WTQL referral	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	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)	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	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

Outcome Measure	Measure Description	Time Frame
Cost per successful WTQL referral	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

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Danielle McCarthy, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Salvation Army
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking; Smoking Cessation; Tobacco Use
• Other Study ID 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