Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by David Strong, BA, MS, PhD
Headshot of David Strong
David Strong

Description

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.

Details

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.

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, EMPACT-Us

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

Locations

  • University of California San Diego in progress, not accepting new patients
    San Diego California 92037 United States
  • Family Health Centers of San Diego accepting new patients
    San Diego California 92102 United States

Lead Scientist at UCSD

  • David Strong, BA, MS, PhD
    As a clinical psychologist within the Herbert Wertheim School of Public Health and Human Longevity Science, I am committed to the mission to improve health through preventive, epidemiological and clinical research.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Family Health Centers of San Diego
ID
NCT05750537
Study Type
Interventional
Participants
Expecting 13496 study participants
Last Updated