Smoking Cessation E-Visit for Quitting Smoking

(INSPIRE Trial)

Overseen By Noelle E Natale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Cessation medications

Disqualifiers: Current cessation treatment, others

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

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

288 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation across rural primary care settings. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be currently using an FDA-approved smoking cessation medication to participate.

What data supports the effectiveness of the smoking cessation e-visit treatment for quitting smoking?

Research shows that the smoking cessation e-visit treatment is promising, with participants reporting satisfaction and interest in using it again. The study found that smoking cessation outcomes were generally better for those using the e-visit compared to usual care, with higher odds of quitting smoking at both 1 and 3 months after starting the program. ^{1 2 3 4 5}

Is the Smoking Cessation E-Visit generally safe for humans?

The research does not provide specific safety data for the Smoking Cessation E-Visit, but it suggests that online smoking cessation programs, like the ones studied, are generally used without major safety concerns. ^{2 6 7 8 9}

How is the Smoking Cessation E-Visit treatment different from other smoking cessation treatments?

The Smoking Cessation E-Visit treatment is unique because it leverages the Internet to deliver smoking cessation support, making it accessible remotely and potentially more convenient for users compared to traditional in-person methods. This approach can be used as a stand-alone program or alongside other treatments, offering flexibility and ease of access for individuals seeking to quit smoking. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for adults who smoke at least 5 cigarettes daily, have been smoking regularly for over 6 months, and are not currently using any quit-smoking treatments. Participants must live where they can get mail, speak English, use or be willing to sign up for Epic's MyChart program, check their email daily, and own a smartphone compatible with the study's breath sample app.

Inclusion Criteria

I have been smoking more than 5 cigarettes daily for the last 6 months.

I am 18 years old or older.

Have a valid address at which mail can be received (for mailing iCO™)

Exclusion Criteria

I have started a smoking cessation treatment with FDA-approved medication in the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote screening via REDCap

Treatment

Participants receive the smoking cessation e-visit intervention or treatment as usual

24 weeks

4 e-visits (remote)

Follow-up

Participants are monitored for smoking cessation outcomes and reduction in cigarette use

6 months

3 follow-up assessments (remote)

Treatment Details

Interventions

• Smoking cessation e-visit
• Treatment as usual

Trial Overview The study is testing an online e-visit system designed to help people stop smoking in rural primary care settings. Some participants will receive this e-visit intervention while others will continue with usual care. The e-visit includes questions about smoking habits and may lead to a prescription for quitting aids but doesn't require taking medication.

Participant Groups

Group I: Smoking cessation electronic visit (e-visit) Experimental Treatment 1 Intervention

This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.

Group II: Treatment as usual (TAU) Active Control 1 Intervention

This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.

Smoking cessation e-visit is already approved in United States for the following indications:

Approved in United States as Smoking Cessation e-visit for:

• Smoking cessation

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study evaluated an asynchronous smoking cessation e-visit for adult smokers in primary care, involving 51 participants, and found it to be acceptable and feasible, with high satisfaction rates among users.

The e-visit showed promising efficacy in improving smoking cessation outcomes compared to standard treatment, with participants having higher odds of quitting at both 1 month (ORs: 2.10-5.39) and 3 months (ORs: 1.31-4.67) post-enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Dahne, J., Player, M., Carpenter, MJ., et al.[2022]

The Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC) program showed a smoking abstinence rate of 11.9% at 12 months, which is comparable to other effective interventions, but did not significantly outperform a minimal control intervention in the long term.

Higher intensity of use of the TK-SCC program was associated with greater success in quitting smoking, indicating that encouraging consistent engagement with the program could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial. Maiwald, P., Bischoff, M., Lindinger, P., et al.[2023]

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]

Computer-based smoking cessation programs are effective and can be delivered on a large scale at a low cost, making them accessible to many smokers.

These programs work best when combined with pharmacotherapy and can serve as a helpful addition to counseling provided by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. Etter, JF.[2017]

The Decide2Quit program, a tailored web-based and e-message smoking cessation intervention, is being tested on 1,488 hospitalized smokers to evaluate its effectiveness in promoting tobacco cessation after discharge.

The primary outcome of the study is self-reported 30-day tobacco abstinence at 6 months, with secondary outcomes including various quit rates and cost-effectiveness assessments, highlighting the program's potential for broad implementation with minimal burden on hospital staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. Harrington, KF., McDougal, JA., Pisu, M., et al.[2021]

In a study comparing web-based and phone-based assessments for a Facebook smoking cessation program, the web-based approach resulted in significantly higher enrollment rates (67.9% vs. 32.7%) and lower costs per participant ($27 for WEB vs. $87 for PH).

Despite the differences in enrollment rates, both methods had similar follow-up completion rates (43% for WEB and 46% for PH), indicating that while web-based assessments are more effective for enrollment, they do not compromise participant retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. Villanti, AC., Jacobs, MA., Zawistowski, G., et al.[2018]

The study evaluated the effects of five different smoking cessation interventions on 1,034 smokers, revealing that both the National Cancer Institute's website and nicotine replacement therapy (NRT) significantly increased smoking abstinence rates.

However, the effectiveness of the NCI website was reduced when combined with motivational email messages, indicating that certain interventions may interact negatively with each other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five population-based interventions for smoking cessation: a MOST trial. Fraser, D., Kobinsky, K., Smith, SS., et al.[2022]

The QUIT-PRIMO study aims to enhance tobacco cessation efforts by using an online referral portal that allows healthcare providers to automatically send educational resources and support to smokers, potentially increasing their chances of quitting.

This study will evaluate the effectiveness of this integrated informatics system across 160 primary care practices, comparing referral rates and patient engagement with both standard and enhanced smoking cessation resources over a six-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol. Houston, TK., Sadasivam, RS., Ford, DE., et al.[2022]

In a pilot study involving 30 smokers willing to quit, the integration of tailored e-mail consultation messages into a smoking-cessation program was found to be feasible and effective, with 37% of participants maintaining abstinence at the 6-month follow-up.

Participants who received more frequent e-mail counseling (4-8 times) showed a significant reduction in carbon monoxide levels, indicating successful smoking cessation compared to those who received less counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using E-mail counseling as part of a smoking-cessation program. Polosa, R., Russo, C., Di Maria, A., et al.[2009]

Approximately 1.6% to 2.5% of adult smokers expressed interest and enrolled in Project Quit, an online smoking cessation program, indicating a notable interest in digital support for quitting smoking.

Proactive recruitment methods, such as invitation letters sent to likely smokers, were significantly more effective than other strategies, leading to 69% of website visitors and 68% of enrollees, highlighting the importance of targeted outreach in engaging smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. McClure, JB., Greene, SM., Wiese, C., et al.[2022]

Physicians identified the smoking status of their patients in 66% of outpatient visits, but many identified smokers did not receive smoking cessation counseling, indicating a gap in intervention.

Generalist physicians provided smoking cessation advice more frequently than specialists, especially during non-tobacco-related visits, suggesting that the type of visit influences the likelihood of receiving cessation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for prevention: smoking cessation counseling and the competing demands of practice. Jaén, CR., Stange, KC., Tumiel, LM., et al.[2018]

The STOP program, which provided smoking cessation treatment to over 107,000 patients from 2005 to 2016, revealed that different treatment models attracted diverse patient populations, with younger individuals preferring web-based options and older patients utilizing primary care services.

Patients in practitioner-mediated models, like Family Health Teams, had higher rates of chronic health issues such as COPD and hypertension, indicating these models are better suited for smokers with complex healthcare needs, while web and telephone models reached fewer patients from rural and lower socioeconomic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in patient sociodemographics, clinical characteristics, and healthcare service utilization among 107,302 treatment seeking smokers in Ontario: A cross-sectional comparison. Baliunas, D., Zawertailo, L., Voci, S., et al.[2020]

The MobileQuit program, designed specifically for mobile devices, significantly outperformed the QuitOnline program in helping smokers quit, with abstinence rates of 20.7% at 3 months and 24.6% at 6 months compared to 11.4% and 19.3% for QuitOnline, respectively.

Participants using MobileQuit engaged with the program 5 times more frequently than those using QuitOnline, highlighting the importance of mobile optimization in smoking cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. Danaher, BG., Tyler, MS., Crowley, RC., et al.[2023]

A study of 1000 adult smokers from the US and UK found that those motivated to quit smoking were more likely to use technology, such as smartphones and social media, compared to those who were unmotivated.

Despite lower technology use among unmotivated smokers, there is enough prevalence of technology use to justify developing eHealth and mHealth interventions, suggesting that simpler communication methods like text messaging could be effective for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Frequency of mHealth and eHealth Use Among US and UK Smokers and Differences by Motivation to Quit. Borrelli, B., Bartlett, YK., Tooley, E., et al.[2019]

References

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

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial. [2023]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Five population-based interventions for smoking cessation: a MOST trial. [2022]

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

The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol. [2022]

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

Feasibility of using E-mail counseling as part of a smoking-cessation program. [2009]

10. Canada pubmed.ncbi.nlm.nih.gov

Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. [2022]

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

Missed opportunities for prevention: smoking cessation counseling and the competing demands of practice. [2018]

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

Variability in patient sociodemographics, clinical characteristics, and healthcare service utilization among 107,302 treatment seeking smokers in Ontario: A cross-sectional comparison. [2020]

13. Canada pubmed.ncbi.nlm.nih.gov

Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. [2023]

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

Prevalence and Frequency of mHealth and eHealth Use Among US and UK Smokers and Differences by Motivation to Quit. [2019]