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Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults

Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05612152
Enrollment
1600
Registered
2022-11-10
Start date
2022-11-01
Completion date
2024-07-31
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Brief summary

The goal of this study is to evaluate the effectiveness of a tobacco treatment navigator to improve primary care patient engagement in tobacco cessation support. We compare an ask, advise and connect to the quitline approach vs. the novel tobacco treatment navigator approach on the primary outcomes of receipt of tobacco cessation counseling sessions and receipt of tobacco cessation medications.

Detailed description

Our novel intervention, Choose2Quit, builds on our prior successes with the Ask, Advice, Connect study, but now 1) allows personalized choice of counseling modality (phone, text, web, in-person); 2) conveys the value and low/no-cost availability of medications to support quit attempt success and sends providers the patient's request in e-prescription to transmit to patient's pharmacy; 3) assesses patient's need to manage social barriers to quitting by linking them to Unite-US; and 4) uses an initial phone contact from a recognizable local number, will increase the engagement of patients in cessation treatment and in tobacco cessation. This study aims to: 1. Test the effect of a traditional eReferral vs. a Choose2Quit personalized guidance and choice approach on the ability to contact patients, and the proportion of patients that initiate tobacco cessation treatment, use tobacco cessation medications and make quit attempts. 2. Assess the impact of each intervention arm on equitable engagement in tobacco cessation treatment, medication use and quit outcomes across gender, race and age groups. 3. Evaluate intervention experience from the patient perspective. 4. Evaluate the cost to implement, and per engagement in each of the intervention arms. The study is accomplished using a 2-arm randomized trial. Randomization into the traditional eReferral vs. Choose2Quit intervention arms will occur at the patient level with a 1:1 group assignment. Individuals that are ready to quit in the next 30 days and are interested in being connected with tobacco cessation resources will be randomized. Randomization of eligible patients occurs automatically with an electronic health record algorithm that routes the eReferral to the Quitline (traditional eReferral) or the Choose2Quit intervention. The Ask-Advise-Connect process is exactly the same for medical assistants; medical assistants and patients are blind to group assignment

Interventions

OTHERReferral to Quitline

An electronic referral to the state quitline is placed. This prompts the quitline to proactively call the patient to enroll in counseling services.

OTHERChoose2Quit

An electronic referral to the Choose2quit tobacco cessation navigator is placed. This prompts the navigator to call the patient to review options for tobacco cessation counseling, tobacco cessation medications and other supports.

Sponsors

Case Western Reserve University
CollaboratorOTHER
MetroHealth System, Ohio
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient care visit to one of the participating primary care clinics during the study period * reports current tobacco use * reports interest in quitting tobacco in the next 30 days * accepts offer of referral to tobacco cessation support

Exclusion criteria

* not interested in quitting in next 30 days * not interested in assistance

Design outcomes

Primary

MeasureTime frameDescription
receipt of tobacco cessation counseling4 weeks after referralreceipt of 1 or more tobacco cessation counseling sessions from referral sources
receipt of tobacco cessation medicationswithin 4 weeks after referraldocumentation of orders for nicotine replacement therapy, varenicline or bupropion in electronic health record

Secondary

MeasureTime frameDescription
7-day point prevalence abstinence8 weeks after referral7-day point prevalence abstinence from tobacco use

Contacts

Primary ContactSusan Flocke
flocke@ohsu.edu216 965 5538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026