Tobacco Cessation Interventions for Smoking Addiction

(REI-UT Trial)

Overseen By Chelsey Schlechter, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Opt-out of study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1560 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

Valid cell phone number in the electronic health record (EHR)

Live in a persistent poverty census tract

Electronic health records indicate they have not opted out of receiving text contact from the clinic

Exclusion Criteria

Opt-out of study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinic Level Implementation

Implementation of Ask-Advise-Connect (AAC) strategy to address tobacco cessation and SDOH needs

4 weeks

1 visit (in-person)

Patient Level Intervention

Randomized patient-level strategies including Conversational Agents and Patient Navigation

12 months

Proactive outreach via text and calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: 9: Non-Bundled, PPN Dose, CA6 Experimental Treatment 3 Interventions

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

Group II: 8: Non-Bundled, PPN Dose, CA3 Experimental Treatment 3 Interventions

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

Group III: 7: Non-Bundled, PPN Dose, CA1 Experimental Treatment 3 Interventions

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

Group IV: 6: Non-Bundled, RPN, CA12 Experimental Treatment 3 Interventions

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

Group V: 5: Non-Bundled, RPN, CA9 Experimental Treatment 3 Interventions

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

Group VI: 4: Non-Bundled, RPN, CA6 Experimental Treatment 3 Interventions

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

Group VII: 3: Non-Bundled, RPN, CA3 Experimental Treatment 3 Interventions

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

Group VIII: 2: Non-Bundled, RPN, CA1 Experimental Treatment 3 Interventions

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

Group IX: 21: Bundled, PPN, CA12 Experimental Treatment 3 Interventions

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

Group X: 20: Bundled, PPN, CA9 Experimental Treatment 3 Interventions

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

Group XI: 1: Clinic Level Intervention Only Experimental Treatment 1 Intervention

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

Group XII: 19: Bundled, PPN, CA6 Experimental Treatment 3 Interventions

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

Group XIII: 18: Bundled, PPN, CA3 Experimental Treatment 3 Interventions

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

Group XIV: 17: Bundled, PPN, CA1 Experimental Treatment 3 Interventions

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

Group XV: 16: Bundled, RPN, CA12 Experimental Treatment 3 Interventions

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

Group XVI: 15: Bundled, RPN, CA9 Experimental Treatment 3 Interventions

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

Group XVII: 14: Bundled, RPN, CA6 Experimental Treatment 3 Interventions

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

Group XVIII: 13: Bundled, RPN, CA3 Experimental Treatment 3 Interventions

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

Group XIX: 12: Bundled, RPN, CA1 Experimental Treatment 3 Interventions

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

Group XX: 11: Non-Bundled, PPN Dose, CA12 Experimental Treatment 3 Interventions

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

Group XXI: 10: Non-Bundled, PPN Dose, CA9 Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10256885/

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5820724/

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] ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076231211634

Conversational artificial intelligence interventions to ... We found limited but promising evidence on the effectiveness of conversational artificial intelligence interventions for tobacco cessation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425003052

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01414036

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10623979/

Conversational artificial intelligence interventions to support ... Our analysis of three studies demonstrated significant positive effects of conversational AI interventions for smoking cessation, however, these ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076231182807

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 ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/71/NCT03452371/Prot_SAP_000.pdf

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.

9. mdpi.com mdpi.com/1660-4601/19/7/4034

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 ...