Smoking Cessation E-Visit for Quitting Smoking
(INSPIRE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Cessation medications
Disqualifiers: Current cessation treatment, others
No Placebo Group
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.12345
Is the Smoking Cessation E-Visit generally safe for humans?
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.1011121314
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™)
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Exclusion Criteria
I have started a smoking cessation treatment with FDA-approved medication in the last week.
Trial 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 (Behavioral Intervention)
- Treatment as usual (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Smoking cessation electronic visit (e-visit)Experimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. [2022]Background:Best practice guidelines for smoking cessation treatment through primary care advise the 5As model. However, compliance with these guidelines is poor, leaving many smokers untreated. The purpose of this study was to develop and preliminarily evaluate an asynchronous smoking cessation electronic visit (e-visit) that could be delivered proactively through the electronic health record (EHR) to adult smokers treated within primary care. The goal of the e-visit is to automate 5As delivery to ensure that all smokers receive evidence-based cessation treatment. As such, the aims of this study were twofold: (1) to examine acceptability, feasibility, and treatment metrics associated with e-visit utilization and (2) to preliminarily examine efficacy relative to treatment as usual (TAU) within primary care.Methods:Participants (n = 51) were recruited from primary care practices between November 2018 and October 2019 and randomized 2:1 to receive either the smoking cessation e-visit or TAU. Participants completed assessments of cessation outcomes 1-month and 3-months postenrollment and e-visit analytics data were gathered from the EHR.Results:Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future. Nearly all e-visits resulted in prescription of a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication. In general, smoking cessation outcomes favored the e-visit condition at both 1 (odds ratios [ORs]: 2.10-5.39) and 3 months (ORs: 1.31-4.67).Conclusions:These results preliminarily indicate the feasibility, acceptability, and efficacy of this smoking cessation e-visit within primary care. Future studies should focus on larger scale examination of effectiveness and implementation across settings. The clinicaltrials.gov registration number for this trial is NCT04316260.
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]eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity.
Which eHealth interventions are most effective for smoking cessation? A systematic review. [2022]To synthesize evidence of the effects and potential effect modifiers of different electronic health (eHealth) interventions to help people quit smoking.
Using new information technology to treat tobacco dependence. [2017]Smoking cessation programs that can be disseminated at a large scale and at a low cost are needed to decrease smoking-related mortality and morbidity. Research showed that several computer-based smoking cessation programs are effective, in particular when they are combined with pharmacotherapy. When available on the Internet, these programs can reach thousands of smokers at a low cost per participant. Some of these programs are designed to complement smoking cessation counseling given by physicians to their patients who smoke. They can be a useful adjunct to medical advice and should be prescribed in association with pharmacotherapy.
Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. [2021]E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit).
Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. [2018]Few studies have addressed enrollment and retention methods in online smoking cessation interventions. Fully automated Web-based trials can yield large numbers of participants rapidly but suffer from high rates of attrition. Personal contact with participants can increase recruitment of smokers into cessation trials and improve participant retention.
Five population-based interventions for smoking cessation: a MOST trial. [2022]Little is known about the relative, additive, and interactive effects of different population-based treatments for smoking cessation. The goal of this study was to evaluate the main and interactive effects of five different smoking interventions. Using the multiphase optimization strategy (MOST), 1,034 smokers who entered a Web site for smokers (smokefree.gov) were randomly assigned to the "on" and "off" conditions of five smoking cessation interventions: the National Cancer Institute's (NCI) Web site (www.smokefree.gov vs a "lite" Web site), telephone quitline counseling (vs none), a smoking cessation brochure (vs a lite brochure), motivational e-mail messages (vs none), and mini-lozenge nicotine replacement therapy (NRT vs none). Analyses showed that the NCI Web site and NRT both increased abstinence; however, the former increased abstinence significantly only when it was not used with the e-mail messaging intervention (messaging decreased Web site use). The other interventions showed little evidence of effectiveness. There was evidence that mailed nicotine mini-lozenges and the NCI Web site (www.smokefree.gov) provide benefit as population-based smoking interventions.
The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol. [2022]Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group).
Feasibility of using E-mail counseling as part of a smoking-cessation program. [2009]The need for more effective smoking-cessation interventions is firmly established. However, access to these services can be problematic in real life. E-mail messages may be a convenient alternative to deliver smoking-cessation interventions. The aim of this pilot study was to assess the effectiveness of incorporating tailored e-mail consultation messages in a smoking-cessation program for smokers willing to quit.
Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. [2022]The Internet is a promising venue for delivering smoking cessation treatment, either as a stand-alone program or as an adjunct to pharmacotherapy. However, there is little data to indicate what percent of smokers are interested in receiving online smoking cessation services or how best to recruit smokers to Internet-based programs.
Missed opportunities for prevention: smoking cessation counseling and the competing demands of practice. [2018]Smoking cessation advice is an effective intervention for the control of tobacco use. The objective of this study was to assess and describe the rates of smoking status assessment and smoking cessation advice provided by physicians during ambulatory office visits with respect to physician specialty, type of visit, and number of problems addressed at the visit.
Variability in patient sociodemographics, clinical characteristics, and healthcare service utilization among 107,302 treatment seeking smokers in Ontario: A cross-sectional comparison. [2020]Since 2005, the Smoking Treatment for Ontario Patients (STOP) program has provided smoking cessation treatment of varying form and intensity to smokers through 11 distinct treatment models, either in-person at partnering healthcare organizations or remotely via web or telephone. We aimed to characterize the patient populations reached by different treatment models.
Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. [2023]Many best practice smoking cessation programs use fully automated internet interventions designed for nonmobile personal computers (desktop computers, laptops, and tablets). A relatively small number of smoking cessation interventions have been designed specifically for mobile devices such as smartphones.
Prevalence and Frequency of mHealth and eHealth Use Among US and UK Smokers and Differences by Motivation to Quit. [2019]Both mHealth and eHealth interventions for smoking cessation are rapidly being developed and tested. There are no data on use of mHealth and eHealth technologies by smokers in general or by smokers who are not motivated to quit smoking.