Clinical trial NCT05612152: Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults
Official title: Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: MetroHealth System, Ohio
First posted: 2022-11-10
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: receipt of tobacco cessation counseling
timeFrame: 4 weeks after referral
measure: receipt of tobacco cessation medications
timeFrame: within 4 weeks after referral
Secondary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: 8 weeks after referral
Other outcomes:
Locations:
Study officials:
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