NCT05750537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13,496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 7, 2024

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

February 7, 2023

Last Update Submit

February 6, 2024

Conditions

Tobacco Use Cessation

Keywords

Tobacco Use CessationFQHCSan DiegoElectronic Health RecordEHRKick It CaliforniaFHCSDUCSDFamily Health Centers of San DiegoUniversity of California San DiegoCaliforniaSouthern CaliforniaLow-income populationsSmoking Cessation

Outcome Measures

Primary Outcomes (3)

  • Engagement with tobacco-use treatment as captured through Electronic Health Record queries

    Engagement with tobacco use treatment is defined as at least one dose/session of evidence-based pharmacotherapy or behavioral counseling for smoking cessation using the EHR.

    7 to 35 months

  • Tobacco-use quit attempts as assessed through Electronic Health Record queries

    Quit attempts are defined as the stated intention to achieve long-term cessation and an ability to refrain smoking evidenced by a self-reported 24-hour period of no smoking. ((e.g. C-TUQ: How long has it been since you last smoked a cigarette (even one or two puffs)?))

    7 to 35 months

  • Biochemically verified tobacco-use cessation as assessed through cotinine saliva test

    Tobacco-use cessation is defined as prolonged abstinence at the 6- and 12- month follow periods, biochemically verified through cotinine saliva tests.

    6 and 12 months

Study Arms (2)

EMPACT-Us

EXPERIMENTAL

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

Behavioral: EMPACT-Us

Newly-enhanced usual care (EUC)

NO INTERVENTION

Newly-enhanced usual care (EUC)

Interventions

EMPACT-UsBEHAVIORAL

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

EMPACT-Us

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current tobacco user
  • years old
  • Speaks English or Spanish
  • Nationality
  • Mental health status
  • Substance use
  • Race
  • Sexual orientation
  • Ethnicity
  • Reports abstinence at follow-up assessment

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patients with a lung cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

San Diego, California, 92037, United States

ACTIVE NOT RECRUITING

Family Health Centers of San Diego

San Diego, California, 92102, United States

RECRUITING

Related Publications (6)

  • Flocke SA, Vanderpool R, Birkby G, Gullett H, Seaman EL, Land S, Zeliadt S. Addressing Tobacco Cessation at Federally Qualified Health Centers: Current Practices & Resources. J Health Care Poor Underserved. 2019;30(3):1024-1036. doi: 10.1353/hpu.2019.0071.

    PMID: 31422986BACKGROUND

  • Flocke SA, Seeholzer E, Lewis SA, Gill IJ, Rose JC, Albert E, Love TE, Kaelber D. 12-Month Evaluation of an EHR-Supported Staff Role Change for Provision of Tobacco Cessation Care in 8 Primary Care Safety-Net Clinics. J Gen Intern Med. 2020 Nov;35(11):3234-3242. doi: 10.1007/s11606-020-06030-7. Epub 2020 Jul 23.

    PMID: 32705473BACKGROUND

  • Fernandez ME, Schlechter CR, Del Fiol G, Gibson B, Kawamoto K, Siaperas T, Pruhs A, Greene T, Nahum-Shani I, Schulthies S, Nelson M, Bohner C, Kramer H, Borbolla D, Austin S, Weir C, Walker TW, Lam CY, Wetter DW. QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers. Implement Sci. 2020 Jan 30;15(1):9. doi: 10.1186/s13012-020-0967-2.

    PMID: 32000812BACKGROUND

  • Fiore M, Adsit R, Zehner M, McCarthy D, Lundsten S, Hartlaub P, Mahr T, Gorrilla A, Skora A, Baker T. An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):778-786. doi: 10.1093/jamia/ocz044.

    PMID: 31089727BACKGROUND

  • Levinson AH, Valverde P, Garrett K, Kimminau M, Burns EK, Albright K, Flynn D. Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. BMC Public Health. 2015 Jul 9;15:627. doi: 10.1186/s12889-015-1962-4.

    PMID: 26155841BACKGROUND

  • Ramirez GF, Badii NZ, Mohn P, Northrup A, Smoot C, Doran N, Brouwer K, Myers M, Godino J, Liu J, Ghobrial-Sedky K, Strong D. Assessing the effects of Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use within a federally qualified health center (EMPACT-Us): a protocol study. BMC Public Health. 2024 Dec 18;24(1):3496. doi: 10.1186/s12889-024-20997-6.

    PMID: 39695566DERIVED

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • David Strong, BA, MS, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Karim Ghobrial-Sedky, MD, MSc, DFAPA

    Family Health Centers of San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Strong, BA, MS, PhD

CONTACT

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

Karim Ghobrial-Sedky, MD, MSc, DFAPA

CONTACT

619-515-2300karimg@fhcsd.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Stepped-wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 1, 2023

Study Start

February 27, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 7, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)