Tobacco UseNCT06689774
Salvation Army Tobacco Quit Line Referral Implementation Trial
A study testing Cognitive-Motivational Feedback, Staff Tobacco Quit Line Referral Implementation Support and Consumer Incentives for Immediate Referral to a Tobacco Quit Line in people with Tobacco Use and Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Smoking, Smoking Cessation
- What is being tested?
- Cognitive-Motivational Feedback, Staff Tobacco Quit Line Referral Implementation Support and Consumer Incentives for Immediate Referral to a Tobacco Quit Line
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Children under the age of 18
- Unable to speak a common language with a study team member or available interpreter
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use, Smoking, Smoking Cessation
- Being tested
- Cognitive-Motivational Feedback, Staff Tobacco Quit Line Referral Implementation Support, Consumer Incentives for Immediate Referral to a Tobacco Quit Line
- Keywords
- Salvation Army
- Medical subject headings
- Tobacco Use, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Motivational FeedbackBehavioural
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.
Staff Tobacco Quit Line Referral Implementation SupportBehavioural
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.
Consumer Incentives for Immediate Referral to a Tobacco Quit LineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive-Motivational Feedback; Behavioral: Staff Tobacco Quit Line Referral Implementation Support; Behavioral: Consumer Incentives for Immediate Referral to a Tobacco Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 18 months
Secondary outcomes (4)
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
Measured: 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)
Measured: 18 months
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%.
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Danielle McCarthy, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689774
- Sponsor's protocol ID
- 2024-0978
- Other IDs
- UG3CA293756, A534253, Protocol Version 4/28/26
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Pragmatic Randomized Rollout Trial to Evaluate Implementation Strategies to Promote Smoking Treatment and Cancer Prevention for Salvation Army Clients
- ClinicalTrials.gov ID
- NCT06689774
- Acronym / sponsor ID
- 2024-0978
- Conditions
- Tobacco Use, Smoking, Smoking Cessation
- Keywords
- Salvation Army
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support | Experimental | Behavioral: Cognitive-Motivational Feedback, Behavioral: Staff Tobacco Quit Line Referral Implementation SupportBoth 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. |
| Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral | Experimental | Behavioral: Cognitive-Motivational Feedback, Behavioral: Staff Tobacco Quit Line Referral Implementation Support, Behavioral: Consumer Incentives for Immediate Referral to a Tobacco Quit LineIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children under the age of 18
- Unable to speak a common language with a study team member or available interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Motivational FeedbackSalvation 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. | Behavioural | Enhanced Wisconsin Tobacco Quit Line (WTQL) Referral Implementation Support, Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral |
| Staff Tobacco Quit Line Referral Implementation SupportSalvation 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. | Behavioural | 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 LineSalvation 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. | Behavioural | Incentivized Immediate Wisconsin Tobacco Quit Line (WTQL) Referral |
Primary outcome
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.
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.
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%.
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.
4 secondary outcomes
Self-reported abstinence from smoking in the past 7 days
Time frame: 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
Salvation Army personnel adoption of WTQL referral
Time frame: 18 months
Cost per successful WTQL referral
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle McCarthy, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Motivational Feedback, Staff Tobacco Quit Line Referral Implementation Support and Consumer Incentives for Immediate Referral to a Tobacco Quit Line in people with Tobacco Use and Smoking, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wisconsin Tobacco Quit Line (WTQL) referral rate (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.