Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

NCT04717544 | Completed

• 1 other identifier: 28CP-0040
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking cessation; Implementation; Sustainable

Outcome Measures

Primary Outcomes (3)

• Smoking Cessation Rate

  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.

  Change in carbon monoxide and cotinine levels from Baseline at 3 months

• Smoking Cessation Rate

  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.

  Change in carbon monoxide and cotinine levels from 3 months at 6 months

• Smoking Cessation Rate

  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.

  Change in carbon monoxide and cotinine levels from 6 months at 12 months

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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.

Behavioral: Intervention Arm

Treatment As Usual Arm

NO INTERVENTION

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.

Interventions

Intervention Arm BEHAVIORAL

The smoking cessation intervention will include 1) a six-week, 60-75 minute weekly cognitive-behavioral therapy (CBT) smoking cessation counseling group; and 2) smoking cessation medication include varenicline (Chantix), bupropion (Zyban) and nicotine replacement therapy (NRT). Dispensing these medications will include a 15-minute medication management visit with a prescribing clinician. Clients will choose their own preferred treatment. The standard prescription for NRT will include a transdermal patch at a dose that approximates for current average mg of nicotine intake and nicotine gums or lozenges (in either 2 mg or 4 mg strengths). Prescription for varenicline will be 0.5 mg once daily for three days, then 0.5 mg twice daily for the next four days, then 1 mg twice daily thereafter. Absent any contraindications to the drugs listed above, bupropion (Zyban) 150mg will be offered and prescribed once daily for one week, following by bupropion 300 mg once daily thereafter.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• University of California: collaborator

Study Sites (1)

Los Angeles County Department of Health Services and Department of Mental Health Services

Los Angeles, California, 90012, United States

Location

Related Publications (2)

• Meredith LR, Hurley B, Friedman TC, Lee ML, Rodriguez L, Lopez B, Mtume N, Dixon T, Belani HK, Hsieh S, Ray LA. Implementation of Specialty Tobacco Use Disorder Services in a Community Health Setting: Support for Enhanced Prescription Practices. J Addict Med. 2023 Nov-Dec 01;17(6):677-684. doi: 10.1097/ADM.0000000000001211. Epub 2023 Aug 18.

  PMID: 37934530 DERIVED

• 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.

  PMID: 35115017 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Theodore C Friedman, M.D., Ph.D.

  Charles R. Drew University of Medicine & Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 22, 2021
• Study Start: October 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)