Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion)
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Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
Mi Quit Care is a multi-site study with principal investigators at UIC and Columbia University. Dr. Geri Donenberg 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 the 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). After the feasibility trial is completed, these implementation strategies will be launched at 6 Mile Square Health Centers. 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 extended 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.
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. We now clarify this in the protocol using track changes in the protocol.
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 extended 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 giving 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. In the feasibility trial, we will test implementation strategies with patients at three of these clinics. In the randomized control study (RCT), we will extend these implementation strategies to three additional clinics. We have designed our procedures to support provider care and to be delivered outside the clinical appointment via the patient portal. For the randomized control trial, we will send portal messages to a subset of up to N=3000 patients randomly selected from all patients who meet eligibility criteria.
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:
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.
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, or
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- aged 18 years and older
- current smoker
- English speaking
- Patient at Mile Square Health Center
Exclusion criteria
- aged less than 18
- non-smoker
- non English speaking
- Not a patient at MSHC
Trial design
Primary purpose
Allocation
Interventional model
Masking
3,000 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Alicia Matthews, PhD
Data sourced from clinicaltrials.gov
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