Salvation Army Tobacco Quit Line Referral Implementation Trial

NCT06689774 | Enrolling By Invitation DMC

• 4 other identifiers: 2024-0978UG3CA293756A534253Protocol Version 4/28/26
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use; Smoking; Smoking Cessation

Keywords

Salvation Army

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Self-reported abstinence from smoking in the past 7 days

  3 months, 6 months post target date to quit smoking

• Immediate referral via live calls to Wisconsin Tobacco Quit Line (WTQL)

  18 months

• Salvation Army personnel adoption of WTQL referral

  18 months

• Cost per successful WTQL referral

  18 months

Study Arms (2)

Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support

EXPERIMENTAL

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; Behavioral: Staff Tobacco Quit Line Referral Implementation Support

Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral

EXPERIMENTAL

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; Behavioral: Staff Tobacco Quit Line Referral Implementation Support; Behavioral: Consumer Incentives for Immediate Referral to a Tobacco Quit Line

Interventions

Cognitive-Motivational Feedback BEHAVIORAL

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.

Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support; Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral

Staff Tobacco Quit Line Referral Implementation Support BEHAVIORAL

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.

Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support; Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral

Consumer Incentives for Immediate Referral to a Tobacco Quit Line BEHAVIORAL

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.

Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Danielle McCarthy, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this pilot study, both participating Salvation Army sites will receive the experimental enhanced implementation support intervention, with the timing of launch staggered across sites to facilitate refinement of the implementation support intervention. Both sites will start implementing referral to the Wisconsin Tobacco Quit Line without consumer incentives for connecting with the Quit Line immediately, and will add these incentives a few months after launching Quit Line referral. The timing of incentive introduction will be staggered across the 2 pilot sites to permit refinement of the incentive strategy.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• Access Criteria: IRB approval and meeting restricted use criteria in the data repository.

Locations

US (1)