Proactive support for quitting tobacco in low-income patients
Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use in Low-Income Patients
This study is testing a new support program to help low-income patients quit smoking and see if it works better than the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13496 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Family Health Centers of San Diego Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05750537 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of the Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use (EMPACT-Us) program, which offers a comprehensive suite of tobacco cessation services tailored for low-income patients. Conducted across eight Family Health Centers in San Diego, the trial employs a stepped-wedge cluster randomized design to compare the new intervention against enhanced usual care. The study aims to improve patient engagement in tobacco treatments, increase quit attempts, and achieve biochemically verified cessation at 6 and 12 months post-intervention. Data will be collected through electronic health records and patient surveys to evaluate the program's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are current tobacco users aged 18 and older who speak English or Spanish.
Not a fit: Patients who are pregnant, breastfeeding, or have a lung cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve tobacco cessation rates among low-income patients.
How similar studies have performed: Previous studies have shown promise in using proactive support models for tobacco cessation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Current tobacco user * 18 years old * Speaks English or Spanish No exclusions due to: * Nationality * Mental health status * Substance use * Race * Sexual orientation * Ethnicity Inclusion into saliva collection: * Met level 1 criteria for inclusion into study * Reports abstinence at follow-up assessment Exclusion Criteria: * Pregnant or breastfeeding women * Patients with a lung cancer diagnosis
Where this trial is running
San Diego, California and 1 other locations
- University of California San Diego — San Diego, California, United States (Active_not_recruiting)
- Family Health Centers of San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: David Strong, BA, MS, PhD — University of California, San Diego
- Study coordinator: David Strong, BA, MS, PhD
- Email: dstrong@health.ucsd.edu
- Phone: 858-657-5241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.