Recruiting

Tobacco Cessation

Sponsor:

Family Health Centers of San Diego

Code:

NCT05750537

Conditions

Tobacco Use Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EMPACT-Us

Study Details

Brief summary:

This research study is being conducted to test the effectiveness of the Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use (EMPACT-Us), an innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study.

We hypothesize that EMPACT-Us will be more effective than the newly-enhanced usual care on improving engagement in tobacco treatments, quit attempts and biochemically verified cessation at 6-and 12-months post initial offerings.

Conditions

Tobacco Use Cessation

Study ID

NCT05750537

Start date

Feb 27, 2023

Status verified date

Sep, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

13496 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EMPACT-Us

An innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study.

no intervention: Newly-enhanced usual care (EUC)

Newly-enhanced usual care (EUC)

Interventions

EMPACT-Us

A suite of tobacco cessation services supported by patient navigation designed in close partnership with patients, providers, and community stakeholders.

Primary outcome measure

  • Engagement with tobacco-use treatment as captured through Electronic Health Record queries [ Time Frame: 7 to 35 months ]
  • Tobacco-use quit attempts as assessed through Electronic Health Record queries [ Time Frame: 7 to 35 months ]
  • Biochemically verified tobacco-use cessation as assessed through cotinine saliva test [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

David Strong, BA, MS, PhD

858-657-5241dstrong@health.ucsd.edu

Karim Ghobrial-Sedky, MD, MSc, DFAPA

619-515-2300karimg@fhcsd.org

Locations

Family Health Centers of San Diego

Recruiting

San Diego, California, United States, 92102

Contacts

Paloma A Mohn

619-908-4554palomam@fhcsd.org

Gabriela F Ramirez, BS

619-906-4526gabrielara@fhcsd.org

Principal Investigator:

Karim Ghobrial-Sedky, MD, MSc, DFAPA

More Information

Sponsor

Family Health Centers of San Diego

Last update posted

Feb 7, 2024

Last verified

Sep, 2023

Keywords

  • Tobacco Use Cessation
  • FQHC
  • San Diego
  • Electronic Health Record
  • EHR
  • Kick It California
  • FHCSD
  • UCSD
  • Family Health Centers of San Diego
  • University of California San Diego
  • California
  • Southern California
  • Low-income populations
  • Smoking Cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Family Health Centers of San Diego on 2024-02-07.