Mi Quit Care for Quitting Smoking

Overseen By Rachel Caskey, MD, MaPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Under 18, Non-smoker, others

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

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how various messages and referral methods can help smokers access smoking cessation support. It tests whether specific messages motivate individuals to contact a coach at the Illinois Tobacco Quitline. Participants receive messages through a patient portal to determine which type most effectively prompts them to seek help. English-speaking smokers at Mile Square Health Center are well-suited for this study. As an unphased trial, it provides a unique opportunity to contribute to innovative strategies for smoking cessation support.

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 shows that specific safety information for Mi Quit Care is not available. This program aids smoking cessation by connecting individuals to resources like the Illinois Tobacco Quitline through a patient portal. Although direct safety data is lacking, such programs typically involve advice and support, which generally carry no physical risks.

Mi Quit Care is a behavioral program that uses counseling and support to assist individuals in quitting smoking. Unlike medical treatments such as pills or injections, these programs are often very safe and usually have no side effects, as they do not involve medication.

Prospective participants may find it helpful to speak with the study coordinators. They can provide more details about participation and answer any questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mi Quit Care because it offers a fresh approach to quitting smoking by combining personalized advice with automatic linkage to a quitline and patient navigation. Unlike traditional methods that often rely solely on self-help materials, Mi Quit Care provides a more interactive and supportive experience, potentially increasing the chances of successfully quitting. This method aims to offer smokers a more engaging and guided path to cessation, which could address the gaps left by standard care options.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research has shown that support programs like Mi Quit Care, which participants in this trial may receive, can help people quit smoking. One study found that individuals using an online community to quit smoking had a 15.1% success rate, compared to 4.2% for those who did not use it. Additionally, the Michigan Tobacco Quitlink program reported a 27% success rate among its participants. These findings suggest that structured support and easy access to resources, such as those offered by Mi Quit Care, can significantly increase the chances of quitting. The evidence indicates that guidance and a plan can make a real difference in helping people stop smoking. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel Caskey, MD, MaPP

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for English-speaking adults who currently smoke and are patients at Mile Square Health Centers. It's not for those under 18, non-smokers, or anyone unable to give informed consent due to language barriers or other reasons.

Inclusion Criteria

My gender does not affect my eligibility.

You currently smoke cigarettes.

English speaking

Exclusion Criteria

You do not smoke cigarettes.

I am unable to understand or sign the consent form.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive portal-delivered messages advising and referring them to the Illinois Tobacco Quitline

7 months

Messages delivered via patient portal

Follow-up

Participants are monitored for smoking cessation and engagement with the Illinois Tobacco Quitline

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Mi Quit Care

Trial Overview Mi Quit CARE aims to help people quit smoking by using electronic interventions through patient portals in health centers. The study will test how well this works compared to standard care and explore its feasibility, effectiveness, and cost-effectiveness.

How Is the Trial Designed?

Group I: MiQuit Care Experimental Treatment 1 Intervention

Intervention arm: Advise to quit + automatic linkage to quitline + patient navigation

Group II: Enhanced Standard of Care Active Control 1 Intervention

Active Comparator: Advise to quit + written self-help materials

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 834 patients who smoked at the time of hospitalization for myocardial infarction, 46% successfully quit smoking by 6 months, with higher quit rates linked to hospitals offering inpatient smoking cessation programs and discharge recommendations for cardiac rehabilitation.

Individual smoking cessation counseling did not significantly impact quit rates, and patients with depressive symptoms were less likely to quit, suggesting that effective smoking cessation strategies should include mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of smoking cessation after a myocardial infarction: the role of institutional smoking cessation programs in improving success. Dawood, N., Vaccarino, V., Reid, KJ., et al.[2022]

A hospital-based smoking cessation program that included bedside counseling and follow-up calls significantly improved smoking abstinence rates in patients after a myocardial infarction (MI), with 55% abstinence at 1 year compared to only 34% in minimal care.

Patients with low self-efficacy who did not receive any intervention had a 93% relapse rate by 1 year, highlighting the importance of targeted support for smokers in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of smoking cessation counseling after myocardial infarction. Dornelas, EA., Sampson, RA., Gray, JF., et al.[2022]

In a review of 205 randomized controlled trials (RCTs) of complementary and alternative medicine (CAM) published in 2009, only 21% of trials provided adequate safety reporting regarding adverse events, highlighting a significant gap in safety information.

The median percentage of words dedicated to safety reporting in the results section was only 2.6%, and many trials reported less on safety than on author affiliations, indicating a need for improved transparency in safety data for CAM interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials. Turner, LA., Singh, K., Garritty, C., et al.[2021]

A randomized clinical trial involving 233 very low-income smokers showed that telephonic counseling significantly improved smoking cessation rates, with 21% of participants quitting compared to 8.1% in the usual care group.

The study suggests that individualized telephonic counseling is effective for low-income smokers, indicating that Medicaid managed care plans should invest in such support services to enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing smoking cessation of low-income smokers in managed care. Wadland, WC., Soffelmayr, B., Ives, K.[2019]

In a study involving 802 patients referred for smoking cessation, those who received counseling and follow-up support had a significantly higher smoking cessation rate of 23.0% compared to only 0.7% for those who did not attend counseling.

The high attendance rate (87.3%) for counseling services indicates that physician referrals for smoking cessation interventions are effective, suggesting that expanding these services in medical centers could greatly benefit patients trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician referrals for smoking cessation: outcome in those who show and don't show. Franke, DL., Leistikow, BN., Offord, KP., et al.[2015]

Over 12% of the U.S. population uses herbal therapies annually, leading to significant out-of-pocket expenses, particularly among patients with chronic diseases, highlighting the need for better education among healthcare providers regarding the safety of these therapies.

There is a pressing need for improved post-market surveillance of dietary supplements to monitor safety, identify harmful products, and study their mechanisms of action, as current research has primarily focused on efficacy rather than safety, leading to potential risks for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assurances for dietary supplements policy issues and new research paradigms. Basch, EM., Servoss, JC., Tedrow, UB.[2008]

In a study of 346 atherosclerotic patients, both generic and disease-specific quality of life (QoL) improved significantly within the first year, regardless of smoking cessation status.

Interestingly, some subgroups, such as highly educated patients and those with specific types of cardiovascular disease, reported a decline in QoL after quitting smoking, suggesting that smoking cessation alone may not guarantee improved quality of life for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation may not improve quality of life in atherosclerotic patients. Wiggers, LC., Oort, FJ., Peters, RJ., et al.[2006]

The Minimal Intervention Strategy (C-MIS) combined with nicotine replacement therapy (NRT) showed a 4.3% effectiveness rate in helping cardiovascular outpatients quit smoking, with a number needed to treat of 240 to prevent one death over five years.

The strategy was more effective for first-time clinic attendees, potentially preventing up to 10 deaths across three clinics, while it showed no significant benefit for patients attending routine follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The number of smokers needed to screen and treat in a smoking cessation programme. Storm-Versloot, MN., Vermeulen, H., Wiggers, LC., et al.[2009]

In a study of 230 male patients hospitalized for myocardial infarction (MI), only 52.2% successfully quit smoking 6-12 months post-hospitalization, highlighting the challenges of smoking cessation even after a serious health event.

Factors that significantly predicted successful quitting included higher self-efficacy, lower tobacco dependence, and a non-smoking family environment, suggesting that tailored interventions focusing on these areas could improve cessation rates among MI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation after myocardial infarction: Findings from a cross-sectional survey in Armenia. Hayrumyan, V., Harutyunyan, A., Harutyunyan, T.[2023]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

A study analyzing 489 kratom-related adverse drug reactions (ADRs) reported to the FDA from 2004 to 2021 found that kratom use is associated with significant safety concerns, including a 63-fold higher than expected rate of accidental deaths.

The analysis revealed strong signals for addiction and withdrawal symptoms, as well as a notable number of reports related to toxicity and seizures, indicating that while kratom is popular for treating pain and anxiety, it poses potential health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021. Li, X., Ndungu, P., Taneja, SB., et al.[2023]

Out of 353 medicinal products withdrawn since 1950, only 40 were withdrawn globally, with 75% of these withdrawals based on anecdotal evidence and 68% associated with reported deaths, highlighting potential gaps in the evidence used for withdrawal decisions.

The median time from the first report of an adverse drug reaction to the global withdrawal was 1 year, indicating that while the process has become quicker, inconsistencies in withdrawal procedures still exist, suggesting a need for a standardized approach to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04827420

Study Details | NCT04827420 | Mi QUIT CARE (Mile ... The primary goal of the study is to test strategies that can improve the consistent delivery of current standard of care tobacco reduction activities used by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ... At 3 months, Average Treatment Effects weighted abstinence rates were 4.2% for those who did not use the web-based community, 15.1% for those ...

3. tobaccopreventioncessation.com tobaccopreventioncessation.com/Smoking-Cessation-after-Myocardial-Infarction-Findings-from-a-Cross-sectional-Survey,174359,0,2.html

Smoking Cessation after Myocardial Infarction Though almost all MI patients attempted to quit, only 52.2% were successful abstainers at 6–12 months after hospitalization. Significant ...

4. michigan.gov michigan.gov/mdhhs/-/media/Project/Websites/mdhhs/Keeping-Michigan-Healthy/Chronic-Disease/Tobacco/12-Data-and-Statistics/Outcomes-Reports/MI-Tobacco-Quitlink-Outcomes-Report_2023.pdf

Michigan Tobacco Quitlink 2023 Outcomes Report For people who enrolled from July 2022 through June 2023, Michigan Tobacco Quitlink achieved an overall responder quit rate of 27%, assisting an estimated 922 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001990

Assessing efficacy of a web-based smoking cessation tool The primary outcome is frequency and quality of clinician initiated smoking cessation counseling. Secondary outcomes include, 1) changes in physician knowledge, ...

6. withpower.com withpower.com/trial/phase-8-2021-021fb

Mi Quit Care for Quitting Smoking Is Mi Quit Care safe for humans? The research articles provided do not contain specific safety data for Mi Quit Care or any treatment evaluated under that name.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8674302/

A Study Protocol for Increasing Access to Smoking ... We aim to evaluate the efficacy of a novel delivery system (patient portal) for increasing access to smoking cessation treatment. In preparation ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000357

Brief computer MI to motivate sustained tobacco cessation ... Usual Care (UC) resulted in significantly higher rates of confirmed smoking abstinence at 6-months post-hospital discharge and significantly increased smoking ...

9. medresearch.umich.edu medresearch.umich.edu/labs-departments/clinical-studies/incentives2quit

Incentives2Quit | University of Michigan Medical School Set of resources and links to start your smoking cessation journey. Offers tools and tips to help you quit smoking.