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Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

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ClinicalTrials.gov Identifier: NCT04717544
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Intervention Arm Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Embedding Comprehensive Smoking Cessation Programs Into Community Clinics
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.

 Behavioral: Intervention Arm
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.
No Intervention: Treatment As Usual Arm
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.


Outcome Measures
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Primary Outcome Measures :
  1. Smoking Cessation Rate [ Time Frame: Change in carbon monoxide and cotinine levels from Baseline at 3 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.

  2. Smoking Cessation Rate [ Time Frame: Change in carbon monoxide and cotinine levels from 3 months at 6 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.

  3. Smoking Cessation Rate [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717544


Contacts
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Contact: Luz Rodriguez 3232385611 lrodriguez4@dhs.lacounty.gov

Locations
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United States, California
Los Angeles County Department of Health Services and Department of Mental Health Services Recruiting
Los Angeles, California, United States, 90012
Contact: Luz Rodriguez    323-238-5611    lrodriguez4@dhs.lacounty.gov   
Sponsors and Collaborators
Friends Research Institute, Inc.
University of California
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04717544    
Other Study ID Numbers: 28CP-0040
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friends Research Institute, Inc.:
Smoking cessation
Implementation
Sustainable