NCT04827420

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2025Aug 2027

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

March 29, 2021

Last Update Submit

March 27, 2026

Conditions

Keywords

Smoking cessationFederally qualified health care centersTobacco quitlinesImplementation Science

Outcome Measures

Primary Outcomes (1)

  • Received Treatment

    Number of participants who received smoking cessation counseling

    7 months

Secondary Outcomes (1)

  • Smoking Cessation

    7 months

Study Arms (2)

MiQuit Care

EXPERIMENTAL

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

Behavioral: Mi Quit Care

Enhanced Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Mi Quit Care

Interventions

Mi Quit CareBEHAVIORAL

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.

Enhanced Standard of CareMiQuit Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Rachel Caskey, MD, MaPP

    University of Illinois Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

January 28, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations