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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various methods to help people quit smoking, using treatments like electronic health records, text messages, and phone calls. The main goal is to connect patients at local health centers with effective resources such as the Utah Tobacco Quit Line. Different groups in the trial test strategies like text messages or phone support. Individuals who currently use tobacco, speak English or Spanish, have a working cellphone, and visit specific community health centers may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that electronic health record (EHR) systems can assist people in quitting smoking by simplifying the process for doctors to recommend cessation treatments. Studies suggest that EHR systems are safe and do not cause major problems.

Additionally, research indicates that counseling or joining a support group can motivate individuals to quit smoking. Although success rates vary, these methods are generally safe.

Phone-based support is another well-researched method. Studies have found it practical and effective in helping more people quit smoking, with no major safety issues reported.

Overall, these methods are widely used and considered safe. They focus on providing support and motivation to help people quit smoking, rather than relying on medicines or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tobacco cessation strategies because they leverage technology and personalized support to enhance quitting success. Unlike standard treatments that often involve medications or self-driven cessation efforts, these interventions integrate Electronic Health Records (EHR) to prompt healthcare providers to actively engage with patients about smoking cessation. Additionally, the use of personalized text messages and direct connections to the Quit Line provide ongoing motivation and easy access to support. Some groups also receive follow-up calls from health educators, which adds a human touch to the tech-driven approach, potentially increasing the chances of quitting. These methods aim to make quitting smoking more accessible and supported, which could lead to higher success rates.

What evidence suggests that this trial's treatments could be effective for tobacco cessation?

Research has shown that Electronic Health Records (EHRs), one of the interventions in this trial, can help clinics support individuals who want to quit smoking. Studies have found a small increase in successful quit rates when EHRs are used, with some clinics achieving significant improvements in reaching smokers. E-health tools, like EHRs, can enhance the chances of quitting compared to traditional methods.

Another intervention in this trial involves phone-based assistance. Evidence indicates that phone-based strategies, such as text messages, are effective for quitting smoking. Specifically, strategies using mobile phones have demonstrated a 63% increase in success rates for quitting. Many participants find these phone supports helpful and encouraging in their efforts to stop smoking. ^{1 2 3 4 6}

Who Is on the Research Team?

David Wetter

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

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.

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

You are currently smoking or using tobacco products.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7173728/

Use of electronic health records to support smoking cessation Studies typically showed positive effects on outcomes including documenting smoking status, giving advice to quit, assessing interest in quitting, and providing ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/13/12/e068629

Clinical impacts of an integrated electronic health record ... Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0091743522001499

Evaluating reach and effectiveness in primary care ... Cessation treatment reach increased significantly after CTIP launch in 5 of 6 clinics and was significantly higher when clinics were active vs. inactive in CTIP ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00589-8/fulltext

Efficacy of e-health interventions for smoking cessation ... The meta-analysis revealed that compared to traditional smoking cessation interventions, e-health interventions can increase point quit rates.

5. medinform.jmir.org medinform.jmir.org/2023/1/e43097/

Monitoring the Implementation of Tobacco Cessation Support ... This study aims to develop a novel monitoring method leveraging EHR activity data and demonstrate its use in monitoring the CDS tools implemented by a tobacco ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838073

Automated Tobacco Cessation Intervention for Parents in ... The eCEASE intervention aimed to support parental smoking cessation via an electronic health record platform plus an offer of tobacco cessation ...