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

Trial Summary

What is the purpose of this trial?

The over-arching research question is: Does message (Advise) and referral approach (Refer) influence a patient's willingness to "opt-in" to receive a call from an Illinois Tobacco Quitline (ITQL) smoking cessation coach in patients at MSHC. Primary UH3 study aim: Compare the effect of the portal-delivered Choice message (Arm 1) to the Information-only message (Arm 3) on linkage to the Illinois Tobacco Quitline (i.e., spoke to a Quitline coach). Secondary UH3 aims are to: Examine the reach of the patient portal for delivering "Advise" and "Refer" at 4 weeks. Reach is defined as a patient opening the portal-delivered provider message across all three Arms. Compare the effect of the Quit message (Quit, Arm 2) to Information-only (Arm 3) on linkage to ITQL. Compare the effect of the Facilitated-referral messages (opt-in link in the message: Arm 1 \& 2) vs. Self-referral (Information-only, Arm 3) on linkage to the ITQL (speaking to an ITQL coach) at four weeks. Compare the effect of the portal-message content of the Choice message (Arm 1) vs. the Quit message (Arm 2) on linkage acceptance (opting in to be called by the ITQL) at 4 weeks. Compare the effectiveness of re-engagement message 1 to message 2 for linkage to the ITQL among patients who opted-in to an ITQL call but who were not reached after 3 attempts. Evaluate the cost-effectiveness of using a patient portal to advise patients to change their smoking behavior and refer them to the ITQL. We will compare the costs associated with our project to the costs associated with advising and referring patients during clinical appointments.

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 Mi Quit Care for quitting smoking?

Research shows that combining nicotine replacement therapy (NRT) with behavioral interventions can help people quit smoking, especially in cardiovascular patients. Additionally, support services like telephone counseling have been found to enhance smoking cessation rates in managed care systems. ^{1 2 3 4 5}

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. Therefore, there is no relevant safety information available from these sources. ^{6 7 8 9 10}

How is the Mi Quit Care treatment for quitting smoking different from other treatments?

The Mi Quit Care treatment is unique because it may involve a structured follow-up and relapse prevention program, which is not always part of standard smoking cessation treatments. This approach could provide more consistent support and increase the chances of successfully quitting smoking. ^{1 2 5 11 12}

Research Team

Rachel Caskey, MD, MaPP

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Smoking cessation after myocardial infarction: Findings from a cross-sectional survey in Armenia. [2023]

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

Enhancing smoking cessation of low-income smokers in managed care. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Smoking cessation may not improve quality of life in atherosclerotic patients. [2006]

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

The number of smokers needed to screen and treat in a smoking cessation programme. [2009]

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

Predictors of smoking cessation after a myocardial infarction: the role of institutional smoking cessation programs in improving success. [2022]

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

The safety of Chinese herbal medicine: a pilot study for a national survey. [2018]

7. United States 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. [2023]

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

Safety assurances for dietary supplements policy issues and new research paradigms. [2008]

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

Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials. [2021]

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

Physician referrals for smoking cessation: outcome in those who show and don't show. [2015]

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

A randomized controlled trial of smoking cessation counseling after myocardial infarction. [2022]