Clinical trial NCT04717544: Embedding Comprehensive Smoking Cessation Programs Into Community Clinics
Official title: Embedding Comprehensive Smoking Cessation Programs Into Community Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Implementation
Sustainable
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: University of California
First posted: 2021-01-22
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Smoking Cessation Rate
timeFrame: Change in carbon monoxide and cotinine levels from Baseline at 3 months
measure: Smoking Cessation Rate
timeFrame: Change in carbon monoxide and cotinine levels from 3 months at 6 months
measure: Smoking Cessation Rate
timeFrame: Change in carbon monoxide and cotinine levels from 6 months at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County Department of Health Services and Department of Mental Health Services
state: California
Study officials:
affiliation: Charles R. Drew University of Medicine & Science
name: Theodore C Friedman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baskerville WA, Friedman TC, Hurley B, Hsieh S, Dixon T, Mtume N, Lee ML, Rodriguez L, Lopez B, Ray LA. Embedding comprehensive smoking cessation programs into community clinics: study protocol for a cluster-randomized controlled trial. Trials. 2022 Feb 3;23(1):109. doi: 10.1186/s13063-022-06023-3.