Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use in Low-Income Patients

NCT ID: NCT05750537

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 13496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2025-06-30

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.

Detailed Description

The investigators propose a stepped-wedge cluster randomized trial. Eight of the largest FHCSD clinics with geographic distribution covering a wide region of San Diego were selected. Based on chart review, the investigators estimate that there are 13,496 tobacco users who are active patients at the selected clinics and could present to one or more clinics during the study period. This population represents roughly 70% of the tobacco users at FHCSD. The larger clinics are chosen based on size, special populations represented, and staff size. The study duration was divided into five 6-month periods. After a baseline period, four pairs of clinics (8 total clinics) will be assigned randomly to begin the active treatment at one of the four subsequent periods. No other clinic characteristics are used for randomization. Tobacco users first tobacco-related visit will anchor subsequent assessments of tobacco use and engagement in tobacco treatments within their electronic medical records and in surveys during the duration of the study.

Activities are designed to evaluate tobacco treatments within FHCSD and to generalize these evaluations to other health clinics serving similar low-income communities. Activities are organized within the Milestones, each building upon the other, leading to the ultimate test of two workflows offering a suite of tobacco cessation services. Milestone 1 (1-6mo) includes startup and training (TE Coach curriculum adaptation, MA training, Primary Care Provider (PCP) training) and baseline data collection using system-level infrastructure assessment and rapid, iterative improvement; Milestone 2 (6-33mo) includes the testing of EMPACT-Us suite of services, with evaluation and fidelity checks built into implementation through Milestone 3 (4-33mo.), which will include conducting qualitative semi-structured interviews and surveys designed to understand the experiences of patients, N-MAs, PCPs, and TE Coaches. Staff will be interviewed either in person or remotely, while patients will be offered surveys either remotely over the phone or via email or SMS beginning two to four weeks after their index visit.; Milestone 4 (7-35mo) data analysis weaves through most of the study to inform work as the investigation progresses; and Milestone 5 (6-36mo) manuscript preparation and dissemination, is planned throughout the study period and beyond.

For the current project, UC San Diego investigators and staff are engaged with FHCSD in delivering the intervention that the investigators partnered to develop. While primarily housed at UC San Diego, this project will include regular onsite interactions with clinical records, individual interviews, interacting with FHCSD providers and viewing clinical information in both clinical intervention training and evaluation roles that again will include contact with patient PHI. The investigators will be removing PHI prior to final qualitative and quantitative analyses and reporting results using de-identified data.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMPACT-Us

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

Group Type: EXPERIMENTAL

EMPACT-Us

Intervention Type: BEHAVIORAL

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

Newly-enhanced usual care (EUC)

Newly-enhanced usual care (EUC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMPACT-Us

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Tobacco Related Disease Research Program

OTHER

Sponsor Role: collaborator

Family Health Centers of San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Strong, BA, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Karim Ghobrial-Sedky, MD, MSc, DFAPA

Role: PRINCIPAL_INVESTIGATOR

Family Health Centers of San Diego

Locations

University of California San Diego

San Diego, California, United States

Site Status: ACTIVE_NOT_RECRUITING

Family Health Centers of San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Strong, BA, MS, PhD

Role: CONTACT

dstrong@health.ucsd.edu

858-657-5241

Karim Ghobrial-Sedky, MD, MSc, DFAPA

Role: CONTACT

karimg@fhcsd.org

619-515-2300

Facility Contacts

Paloma A Mohn

Role: primary

palomam@fhcsd.org

619-908-4554

Gabriela F Ramirez, BS

Role: backup

gabrielara@fhcsd.org

619-906-4526

References

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.

Reference Type: BACKGROUND

PMID: 31422986 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32705473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32000812 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31089727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26155841 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39695566 (View on PubMed)

Other Identifiers

T32CF4745

Identifier Type: -

Identifier Source: org_study_id