Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

Friends Research Institute

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Intervention Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04717544

28CP-0040

Details and patient eligibility

About

The study will evaluate a sustainable tobacco screening, treatment intervention, and cessation program implemented within both Los Angeles County (LAC)-Department of Health Services (LACDHS)-operated outpatient primary care clinics and in LAC-Department of Mental Health (LACDMH)-operated community mental health clinics. This is a three year implementation study funded by the University of California Office of the President Tobacco Related Disease Research Program (TRDRP). This project will support the implementation of smoking cessation services delivered in LACDHS and LACDMH clinics and will evaluate the effectiveness and feasibility of these services.

Full description

The research hypothesis is that training LACDHS and LACDMH staff and clinicians to screen for and treat tobacco use disorder will improve rates of remission from tobacco use disorder in the clients served by each system.

This is a cluster randomized comparative effectiveness trial that compares intervention clinics (offer smoking cessation group counseling and medication management) integrated into primary care and community mental health clinics with treatment as usual (offering information about the California Smoker's Helpline and informal provider counseling). The specific aim is to randomize 17 clinics (11 at LACDHS and 6 at LACDMH), with a 5:1 ratio in the assignment of clinical sites assigned to offer smoking cessation services as compared to the treatment as usual (TAU).

In addition to providing support for the implementation of the smoking cessation services, the study will enroll 1,200 clients with tobacco use disorder from all 17 participating clinics for an outcome study; 1000 people from clinical sites where smoking cessation treatment are being offered and 200 people with tobacco use disorder from the TAU clinical sites. The primary study outcome is to determine if there will be higher rates of smoking cessation in the implementation sites as compared with TAU sites that do not offer smoking cessation treatment.

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years old or older
• smoke 3 or more cigarettes or cigars per day
• have thought about smoking cessation
• be enrolled in care at either LACDHS and/or LACDMH.

Exclusion criteria

• under 18 years
• smoke less than 3 cigarettes or cigars per day
• not interested in smoking cessation
• not enrolled in care at either LACDHS and/or LACDMH.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Intervention Arm

Active Comparator group

Description:

Healthcare providers from clinics participating in the intervention refer existing clients to study coordinators for smoking cessation services, wherein the coordinators link clients to the smoking cessation services, which include: 1) a weekly cognitive-behavioral therapy smoking cessation (CBT) counseling group; and 2) smoking cessation medication, which include varenicline (Chantix), bupropion (Zyban) and nicotine patches, gum, and lozenges. Clients interested in these medications will meet with the prescribing clinician to help choose the best prescription option. In addition to linking clients to the smoking cessation services, coordinators will invite clients to participate in the outcome study. Existing clients can sign-up for these services and/or the outcome study directly with the study coordinators and do not require a healthcare provider referral.

Treatment:

Behavioral: Intervention Arm

Treatment As Usual Arm

No Intervention group

Description:

Existing clients can be referred to the outcome study by their healthcare providers from clinics designated as TAU or they can sign-up directly with the study coordinators.