Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Intervention Arm

• Registration Number: NCT04717544
• Lead Sponsor: Friends Research Institute, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Intervention Arm	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.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation Rate	Change in carbon monoxide and cotinine levels from 6 months at 12 months	The primary outcome is to determine if there will be higher rates of smoking cessation in the intervention sites as compared with matched non-intervention sites. In order to measure these rates, study participants will be asked to complete two objective measures collected at 3-month, 6-month and 12-month follow-up. These measures include a carbon monoxide breathalyzer (piCO+smokerlyzer) and urinary rapid dipstick cotinine test (NicCheck). A participant will count as having quit if they reported having abstained from smoking cigarettes/cigars for seven consecutive days and if this report is corroborated by carbon monoxide and cotinine testing.

Trial Locations

Locations (1)

Los Angeles County Department of Health Services and Department of Mental Health Services; 🇺🇸 Los Angeles, California, United States