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Tobacco Use CessationNCT04827420

Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion)

A study testing Mi Quit Care in people with Tobacco Use Cessation, run by University of Illinois Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use Cessation
What is being tested?
Mi Quit Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteUnited States
Study dates
28 Jan 2025to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged 18 years and older
  • current smoker
  • English speaking
  • Patient at Mile Square Health Center (Main, Englewood, South Shore, Auburn Gresham, Cicero, Back of the Yards)

Who cannot join

  • aged less than 18
  • non-smoker
  • non English speaking
  • Not a patient at MSHC

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

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).

Read more

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.

Read the detailed description

Mi Quit Care is a multi-site study with principal investigators at UIC and Columbia University. Dr. Rachel Caskey is the UIC PI who will oversee all research activities held at UIC and Mile Square Health Center. This includes data collection, intervention delivery, collaboration with community partner, Illinois Tobacco Quitline and Mile Square. Dr. Matthews is the Columbia University PI and who has emirates status at UIC. Their involvement in the study includes the following: involved in meetings, problem solving barriers, monitoring safe and secure data transfer, data analysis and interpretation for de-identified data, dissemination of study results, preparing for future grants, mentoring students, and lead manuscript development. UIC is the grant holder and the IRB of record. A subcontract is in place for Columbia University's involvement (Reference Award 114805). The collaboration of both university in conjunction with the Illinois Tobacco Quitline will create a study to address a simplified version of Ask, Advise, Refer (AAR).

Smoking is the leading preventable cause of death in the U.S. To address this pervasive health risk behavior, all federally qualified health care centers (FQHC) are mandated to provide smoking cessation treatment to all patients who smoke. In 2000, the U.S. Public Health Service clinical practice guideline, Treating Tobacco Use and Dependence, recommended that providers identify and document patients' tobacco use status and treat tobacco users via the "5As" framework (Ask-Advise-Assess-Assist-Arrange). Although effective, the 5As model is time-consuming and challenging to implement. A simplified version (Ask, Advise, Refer, AAR) was developed that resulted in increased patient engagement with recommended treatment approaches such as tobacco quitlines when implemented in clinical settings. Nevertheless, providers continue to experience barriers to the consistent delivery of smoking cessation treatments due to lack of knowledge about appropriate treatments, time constraints, the false belief that most patients are not interested in quitting, and concerns that addressing smoking cessation with their patients may damage the patient provider relationship. Given the high rates of smoking among patients at FQHC settings and the federal mandate to address smoking cessation among all smokers, additional efforts are needed to improve the delivery of care for high-risk and vulnerable populations of smokers.

Implementation science and research approaches are extremely valuable for addressing the unacceptable gap between the demonstration of effective treatments such as "AAR" and barriers to adoption in clinical practice settings. In preparation for a larger Type 3 hybrid implementation-effectiveness study, the purpose of this feasibility study is to evaluate implementation approaches for improving the delivery of the current standard of care smoking cessation treatments (AAR) at Mile Square Health Center (MSHC). 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 providers at MSHC. The study will utilize retrospective chart reviews to identify patients who smoke and extend the current standard of care activities related to smoking cessation treatment. The current MSHC standard of care activities related to smoking cessation treatment include: 1) delivery of "Ask, Advise" by clinic staff and providers then 2) provider "Referral" of patients to the Illinois Tobacco Quitline (ITQL) for free or low-cost smoking cessation treatment. Implementation strategies from the feasibility trial will be integrated into the larger Type 3 implementation-effectiveness randomized controlled trial.

The primary innovation of this study is the use of the Epic linked UI Health Patient Portal platform (MyChart) to deliver the smoking cessation treatment to MSHC patients. This form of delivery is an extension of the current standard of care given at MSHC. Patient portals are secure online websites that give patients convenient, 24-hour access to personal health information from anywhere with an Internet connection. Patient portals have demonstrated benefits for improving patient provider communication, management of chronic health conditions, and patient satisfaction. Patient portals are increasingly being used to deliver health promotion interventions, with positive benefits. However, to our knowledge, no prior projects have examined the use of patient portals to standardize the delivery of referrals for smoking cessation treatment to patients who smoke. This study extends the standard of care to the patient portal. MSHC providers acknowledge inconsistently following the standard of care during clinic visits, and thus, this study proposes to deliver these messages (advise and refer) via the patient portal to increase consistency in message delivery and improve patient access to the standard of care. Because the patient portal was established so providers could communicate with their patients about their health needs, the proposed research is consistent with this goal by using the portal to deliver the same messages. That said, sending provider messages via the patient portal is not the standard of care and instead represents research to convey the messages using a more accessible and reliable approach.

Ask is completed as part of routine care and captured in the medical record. We will use the data documented from "Ask" to identify smokers to send our messages (Advise and Refer). We will test strategies to revise and extend the delivery of the Advise and Refer components of "AAR", a standard of care activity to facilitate smoking cessation treatment, to patients outside of a scheduled health care appointment. The extension of this standard of care is done by offering smoking cessation coaching via MyChart instead of through providers during medical visits. Developing approaches that systematically offer treatment to all patients enrolled in the patient portal addresses several barriers identified by providers including time, lack of expertise, and concerns about the patient provider relationship. Further, it helps to increase health equity because numerous studies have demonstrated that providers are less likely to assist low-income and racial/ethnic minorities with smoking cessation treatment.

Mile Square Health Center (MSHC) has six adult primary care clinics. We will send portal messages to up to N=3000 patients randomly selected from all patients who meet eligibility criteria. Eligibility criteria includes: 1) Had an appointment at one of six MSHC (Main, Englewood, South Shore, Auburn Gresham, Cicero, Back of the Yards) clinics within the past 3 months, 2) English speaking, 3) age 18 years and older, 4) enrolled in MyChart patient portal, and 5) documented as current smoker in Epic.

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. To answer this question, patients will be randomly assigned to one of three message types delivered via the patient portal:

  1. Arm 1 (Choice + Facilitated Referral): Provider advises patient to either cut down or quit smoking as a treatment goal and offers assistance in linking the patient to the ITQL. Patients indicate their acceptance of assistance by clicking the "opt-in" option to receive a call from the ITQL.
  2. Arm 2 (Quit only + Facilitated Referral): Provider advises patient to quit smoking as a treatment goal and offers assistance in linking the patient to the ITQL. Patients indicate their acceptance of assistance by clicking the "opt-in" option to receive a call from the ITQL.
  3. Arm 3 (Information only + Self-Referral): Provider does not advise patient to change their smoking. The Epic delivered message provides Information about the ITQL and the ITQL's telephone number to call if the patient is interested in treatment. This arm replicates the current clinic standard of care practice at MSHC because the information being provided to patients is the same, but the mode of delivery is different.
Being tested
Mi Quit Care
Keywords
Smoking cessation, Federally qualified health care centers, Tobacco quitlines, Implementation Science
Medical subject headings
Tobacco Use Cessation, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mi Quit CareBehavioural

    Demonstrating the feasibility, effectiveness, and cost-effectiveness of electronically delivered smoking cessation interventions via patient portals in Federally Qualified Health Care (FQHC) settings has the potential for wide-spread dissemination and significant public health impact. on patient populations with demonstrated high rates of smoking.

Study groups in NCT04827420
Study groupRoleWhat they receive
MiQuit CareExperimentalIntervention arm: Advise to quit + automatic linkage to quitline + patient navigation
Receives: Behavioral: Mi Quit Care
Enhanced Standard of CareActive comparatorActive Comparator: Advise to quit + written self-help materials
Receives: Behavioral: Mi Quit Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Received Treatment

    Number of participants who received smoking cessation counseling

    Measured: 7 months

Secondary outcomes (1)
  1. Smoking Cessation

    Number of participants who quit smoking

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start28 Jan 2025
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
We are proposing a hybrid type 3 implementation study design (Figure 1) to test the feasibility of delivering tobacco cessation (Advise and Refer components of "AAR") via MyChart/patient portal messaging. We will assess three message types by randomly assigning patients enrolled in MyChart to receive one of three messages - Arm 1: (Choice message + Facilitated referral), Arm 2: (Quit-only + Facilitated referral), or Arm 3 (ITQL Information-only + self-referral). If the patient opts-in to be referred to the quitline, the ITQL will offer an initial intake session to establish treatment goals and then their standard treatment plan.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04827420
Sponsor's protocol ID
2020-0532
Other IDs
1UG3HL151302-01, 4UH3HL151302-04
Status last verified
Mar 2026
First submitted
29 Mar 2021
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matthews AK, Watson KS, Duang C, Steffen A, Winn R. A Study Protocol for Increasing Access to Smoking Cessation Treatments for Low-Income Minority Smokers. Front Public Health. 2021 Dec 2;9:762784. doi: 10.3389/fpubh.2021.762784. eCollection 2021.

    PubMed 34926386

Questions about this trial

What is this clinical trial studying?

A study testing Mi Quit Care in people with Tobacco Use Cessation, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Received Treatment (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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