Clinical trial NCT06689774: Salvation Army Tobacco Quit Line Referral Implementation Trial
Official title: Using a Pragmatic Randomized Rollout Trial to Evaluate Implementation Strategies to Promote Smoking Treatment and Cancer Prevention for Salvation Army Clients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Use
Smoking
Smoking Cessation
Keywords: Salvation Army
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-11-14
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Involved in the management, delivery, or receipt of social services at 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

Primary outcomes:
measure: Wisconsin Tobacco Quit Line (WTQL) referral rate
timeFrame: 18 months
measure: Wisconsin Tobacco Quit Line (WTQL) enrollment rate
timeFrame: 18 months
measure: Salvation Army personnel WTQL referral training engagement
timeFrame: 18 months
measure: Salvation Army personnel adoption of WTQL referral
timeFrame: 18 months
measure: Tobacco use screening of adult consumers of Salvation Army services
timeFrame: 18 months
Secondary outcomes:
measure: Self-reported abstinence from smoking in the past 7 days
timeFrame: 3 months, 6 months post target date to quit smoking
measure: Immediate referral via live calls to Wisconsin Tobacco Quit Line (WTQL)
timeFrame: 18 months
Other outcomes:
measure: Cost per successful WTQL referral
timeFrame: 18 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Danielle McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: