Tobacco Cessation Strategies for Smoking

Overseen By Chelsey Schlechter, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Non-tobacco users, Non-English/Spanish speakers, No cellphone, others

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

Compensation: Varies

Number of Visits: Unknown

12009 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Tobacco Cessation Strategies for Smoking?

Research shows that using electronic health records (EHR) to track smoking status and provide smoking cessation support can significantly increase the number of patients assessed for tobacco use, as seen in a cancer center where assessments rose from 48% to 90%. Additionally, telephone counseling has been found to be an effective aid for quitting smoking, offering benefits beyond routine clinician intervention. ^{1 2 3 4 5}

Is the Tobacco Cessation Strategies for Smoking treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Tobacco Cessation Strategies for Smoking treatment, but they do not report any safety concerns related to the interventions studied, such as electronic health record tools, episodic future thinking, or telephone-based support. ^{6 7 8 9 10}

How does this treatment for smoking cessation differ from other treatments?

This treatment is unique because it combines brief telephone support with outreach to smokers, which may be more effective in reaching and assisting a larger segment of the smoking population compared to traditional methods. ^{11 12 13 14 15}

Research Team

David Wetter

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for current tobacco users who visit Community Health Centers or Federally Qualified Health Centers. Participants must have a working cellphone, be able to receive texts and calls, and speak English or Spanish.

Inclusion Criteria

Participants will have a working cellphone that can accept texts and calls.

I speak English or Spanish.

Participants who present at participating community health center (CHC) clinics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinic-Level Intervention

Clinics receive the AAC intervention to facilitate tobacco cessation through EHR alerts

Ongoing

Phase I (Patient-Level)

Patients receive either text messages or continue with EHR intervention for 6 months

6 months

Phase II (Patient-Level)

Nonresponders receive continued text messages and/or telephone coaching for 6-12 months

6-12 months

Follow-up

Participants are monitored for abstinence and quality of life at 12 months

12 months

Treatment Details

Interventions

• Electronic Health Record intervention
• Smoking Cessation Intervention
• Telephone-Based Intervention

Trial Overview The study tests strategies to help smokers quit by connecting them with the Utah Tobacco Quit Line treatment through telephone-based support, smoking cessation interventions, and electronic health record prompts.

Participant Groups

Group I: Phase II Group II (Text messages continued) Experimental Treatment 3 Interventions

Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.

Group II: Phase II Group I (Text messages, Counseling call) Experimental Treatment 3 Interventions

Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.

Group III: Phase I Group II (Continued clinic-level EHR intervention only) Experimental Treatment 2 Interventions

Patients receive continued clinic level EHR intervention only (CO).

Group IV: Phase I Group I (Continued EHR and text messages) Experimental Treatment 3 Interventions

Patients receive a weekly text message for one month followed by a monthly text message over the next 5 months (i.e., 6 months of text messages following each tobacco users' clinic visit). All messages will include a motivational message, the Quit Line website, the Quit Line phone number, and simple two-touch response that directly connects interested tobacco users to the Quit Line.

Group V: Clinic-Level Experimental Treatment 1 Intervention

Clinics will receive the AAC intervention consisting of an EHR-based point of care alert that prompts clinic staff to Ask every patient about tobacco use, Advise tobacco using patients to quit, and Connect interested tobacco users to the Utah Tobacco Quit Line Assigned Interventions = Electronic Health Record intervention AAC

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The Internet-based smoking cessation intervention combined with a tele-health medication clinic had a greater reach and higher use of smoking cessation aids compared to traditional clinic-based care, involving 413 patients over a 12-month period.

Despite the increased reach, the quit rates at both 3 months (17% vs. 12%) and 12 months (13% vs. 16%) were not significantly different between the Internet intervention and the control group, indicating that more effective strategies are needed to improve smoking cessation outcomes in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. Calhoun, PS., Datta, S., Olsen, M., et al.[2022]

In a study of 837 daily smokers, those receiving telephone care had a significantly higher 6-month smoking cessation rate (13.0%) compared to those receiving standard care (4.1%), indicating that telephone counseling is a more effective intervention.

Participants in the telephone care group were much more likely to engage in counseling programs (97.1% vs 24.0%) and use smoking cessation medications (89.6% vs 52.3%), suggesting that telephone care enhances both behavioral and pharmacological support for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. An, LC., Zhu, SH., Nelson, DB., et al.[2022]

The combination of cognitive-behavioral treatment (CBT) and episodic future thinking (EFT) for smoking cessation in a group of 29 smokers with substance use disorders was found to be acceptable, with a high satisfaction rating of 8.83 out of 10.

Despite the positive reception, adherence to the EFT component was low, with only 15.8% of participants practicing it as recommended, indicating a need for adjustments in future studies to enhance compliance and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. Aonso-Diego, G., González-Roz, A., Martínez-Loredo, V., et al.[2021]

A review of smoking cessation interventions from 1999 to 2007 found that methods like individual counseling, group therapy, and nicotine replacement therapy are significantly effective for helping both healthy and sick patients quit smoking.

Medications such as bupropion, nortriptyline, clonidine, and varenicline also showed proven efficacy, while other interventions did not demonstrate effectiveness in aiding smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking cessation with special focus on primary health care]. Bredesen, H., Lous, J.[2019]

Web-based and mobile health (mHealth) interventions significantly improve smoking cessation rates, with risk ratios of 2.03 and 1.71 respectively, based on a review of 108 studies involving over 110,000 participants.

Tailored text messaging and web-based information combined with nicotine replacement therapy also enhance cessation success, while daily text messages were found to be less effective than weekly ones, highlighting the importance of intervention design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which eHealth interventions are most effective for smoking cessation? A systematic review. Do, HP., Tran, BX., Le Pham, Q., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Documentation of the patient's smoking status in common chronic diseases - analysis of medical narrative reports using the ULMFiT based text classification. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Care-paradigm shift promoting smoking cessation treatment among cancer center patients via a low-burden strategy, Electronic Health Record-Enabled Evidence-Based Smoking Cessation Treatment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid Cycle Evaluation and Adaptation of an Inpatient Tobacco Treatment Service at a U.S. Safety-Net Hospital. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Electronic decision support for treatment of hospitalized smokers: A qualitative analysis of physicians' knowledge, attitudes, and practices. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effects of frequency and duration in telephone counselling for smoking cessation. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A review of computer and Internet-based interventions for smoking behavior. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy and utilization of smartphone applications for smoking cessation among low-income adults: Secondary analysis of the iCanQuit randomized trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Brief supportive telephone outreach as a recruitment and intervention strategy for smoking cessation. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. [2019]

13. Denmark pubmed.ncbi.nlm.nih.gov

[Smoking cessation with special focus on primary health care]. [2019]

14. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Smoking Cessation Interventions: Systematic Review and Meta-Analysis. [2023]

15. New Zealand pubmed.ncbi.nlm.nih.gov

Which eHealth interventions are most effective for smoking cessation? A systematic review. [2022]