Tobacco Cessation Interventions for Smoking Addiction
(REI-UT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people quit smoking through text messages and support from a Community Health Worker. It focuses on increasing the use of existing quit-smoking programs, particularly for those in areas with long-term poverty. Participants will receive messages from a chatbot, part of the Patient Navigation and Conversational Agents approach, and can access personalized help if they have not joined a quit program within four weeks of a clinic visit. This trial may suit individuals who currently use tobacco, visit certain community clinics, and have a cell phone listed in their health records. As an unphased trial, it offers a unique opportunity to access innovative support methods for quitting smoking.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past studies have shown that chatbots help people quit smoking. Participants generally liked these chatbots, finding them useful and supportive. Research also indicates that patient navigation, which guides individuals through the healthcare system, is practical and engaging for those trying to quit smoking.
Although specific safety details for these methods are not provided, existing studies consider using chatbots and patient navigation safe and supportive. Participants in these studies did not report any major negative effects, suggesting these methods are well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for smoking addiction because they use innovative patient navigation and conversational agents (CAs) to enhance support. Unlike traditional methods like nicotine replacement therapy and medication, these treatments focus on personalized, proactive engagement. Patients receive tailored outreach from conversational agents, ranging from one to twelve interactions, encouraging them to enroll in Quit Services. Additionally, the treatments address social determinants of health (SDOH), which are often overlooked in standard care. This approach could lead to more effective and holistic smoking cessation strategies.
What evidence suggests that this trial's treatments could be effective for tobacco cessation?
Research has shown that tools like chatbots and personal guides, included in the interventions tested in this trial, can assist people in quitting smoking. Some studies have found that these tools ease the quitting process by offering personalized support and advice. For instance, chatbots provide tips tailored to individual needs, making the experience more engaging and supportive. Personal guides encourage individuals and offer resources throughout the quitting journey. Although more consistent reporting is needed, these methods have demonstrated promising results in helping people stop smoking.16789
Who Is on the Research Team?
Chelsey Schlechter, MPH, PhD
Principal Investigator
Huntsman Cancer Institute/ University of Utah
Are You a Good Fit for This Trial?
This trial is for patients who use tobacco and live in areas of persistent poverty. They must be part of a safety-net healthcare system and attend Community Health Centers. The study aims to help them quit smoking by increasing access to proven treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Clinic Level Implementation
Implementation of Ask-Advise-Connect (AAC) strategy to address tobacco cessation and SDOH needs
Patient Level Intervention
Randomized patient-level strategies including Conversational Agents and Patient Navigation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Patient Navigation and Conversational Agents
Trial Overview
The trial tests patient-level strategies like Conversational Agents & Patient Navigation, and clinic-level strategies such as Ask-Advise-Connect, aiming to improve the reach of tobacco cessation services among those living in poverty.
How Is the Trial Designed?
21
Treatment groups
Experimental Treatment
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA6
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA3
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA1
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA12
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA9
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA6
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA3
Patients who do not enroll Quit Services within 4 weeks after their clinical encounter will be randomized to receive patient-level strategies. Patients will receive a single proactive outreach from the CA (CA1) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: RPN Dose: CA1
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA12
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA9
Patients who enrolled in Quit Services within 4 weeks after the clinical encounter will not be randomized to patient level conditions. Clinic Level: AAC - Tobacco, AAC - SDOH Bundled/Non-Bundled: NA PRN/RPN: NA Dose: NA
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA6
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA3
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Bundled PRN/RPN: PPN Dose: CA1
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive 12 proactive outreach opportunities from the CA (CA12) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA12
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA9
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive six proactive outreach opportunities from the CA (CA6) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA6
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive three proactive outreach opportunities from the CA (CA3) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA3
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive one proactive outreach opportunity from the CA (CA1) with content that focuses on enrolling in Quit Services and addressing SDOH (Bundled), and will have the opportunity to request calls from a patient navigator (RPN). Bundled/Non-Bundled: Bundled PRN/RPN: RPN Dose: CA1
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive twelve proactive outreach opportunities from the CA (CA12) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA12
Patients who do not enroll Quit Services within 4 weeks of their clinical encounter will be randomized to receive patient-level strategies. Patients will receive nine proactive outreach opportunities from the CA (CA9) with content that focuses solely on enrolling in Quit Services (Non-Bundled), and will receive proactive calls from a patient navigator (PPN). Bundled/Non-Bundled: Non-Bundled PRN/RPN: PPN Dose: CA9
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Effectiveness and Acceptability of Conversational Agents ...
The effectiveness and acceptability of CAs for smoking cessation are promising. However, standardization of reporting and designing of the agents is warranted ...
Effect of Patient Navigation and Financial Incentives on ...
The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results. Among 352 patients who were randomized (mean [SD] ...
Conversational artificial intelligence interventions to ...
We found limited but promising evidence on the effectiveness of conversational artificial intelligence interventions for tobacco cessation.
Protocol for a randomized clinical trial to evaluate the ...
TAMI 2.0 uses ChatGPT-4 to improve conversational quality and provide support. •. TAMI 2.0 may improve the quality and efficiency of smoking cessation treatment ...
Pilot Study of Patient Navigation to Promote Smoking ...
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment.
Conversational artificial intelligence interventions to support ...
Our analysis of three studies demonstrated significant positive effects of conversational AI interventions for smoking cessation, however, these ...
Cocreation of a conversational agent to help patients ...
Adhering to varenicline is strongly associated with smoking cessation. Healthbots have the potential to help people adhere to their medications ...
Hospital-based Patient Navigation to Promote Smoking ...
Population: Study population will include individuals (both men and women, all races and ethnicities) who meet inclusion criteria: (1) hospitalized.
Feasibility of Patient Navigation-Based Smoking Cessation ...
The primary study outcome was the feasibility of the patient navigation-based intervention; the secondary outcome was the engagement in smoking cessation ...
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