Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults

NCT ID: NCT05612152

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-07-31

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

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Referral to Quitline

Patients who indicate they are ready to quit in the next 30 days are offered an electronic referral to the state quitline for tobacco cessation services.

Group Type: ACTIVE_COMPARATOR

Referral to Quitline

Intervention Type: OTHER

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

Choose2Quit

Patients who indicate they are ready to quit in the next 30 days are offered an electronic referral to the Choose2Quit tobacco treatment navigator who walks the patient through choices for tobacco cessation counseling, tobacco cessation medications and other supports (e.g. texting, apps) and facilitates placing referrals, orders and providing information.

Group Type: EXPERIMENTAL

Choose2Quit

Intervention Type: OTHER

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.

Interventions

Referral 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.

Intervention Type: OTHER

Choose2Quit

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

MetroHealth System, Ohio

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Susan Flocke

Role: CONTACT

flocke@ohsu.edu

216 965 5538

Other Identifiers

RSG-18-137-01-CPPB

Identifier Type: -

Identifier Source: org_study_id