Tobacco Use CessationEMPACT-UsNCT05750537
Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use in Low-Income Patients
A study testing EMPACT-Us in people with Tobacco Use Cessation, run by Family Health Centers of San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- EMPACT-Us
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,496 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current tobacco user
- 18 years old
- Speaks English or Spanish
- No exclusions due to:
- Nationality
- Mental health status
Show all 12Show fewer
- Substance use
- Race
- Sexual orientation
- Ethnicity
- Met level 1 criteria for inclusion into study
- Reports abstinence at follow-up assessment
Who cannot join
- Pregnant or breastfeeding women
- Patients with a lung cancer diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
University of California San Diego
San Diego, California, 92037
- Recruiting
Family Health Centers of San Diego
San Diego, California, 92102
Paloma A Mohn, 619-908-4554, palomam@fhcsd.org
Gabriela F Ramirez, BS, 619-906-4526, gabrielara@fhcsd.org
About this study
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.
Read the 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
- Being tested
- EMPACT-Us
- 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
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPACT-UsBehavioural
A suite of tobacco cessation services supported by patient navigation designed in close partnership with patients, providers, and community stakeholders.
| Study group | Role | What they receive |
|---|---|---|
| EMPACT-Us | Experimental | An innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study. Receives: Behavioral: EMPACT-Us |
| Newly-enhanced usual care (EUC) | No intervention | Newly-enhanced usual care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)?))
Measured: 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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start27 Feb 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Stepped-wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 13,496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Family Health Centers of San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- David Strong, BA, MS, PhD, Principal investigator, University of California, San DiegoKarim Ghobrial-Sedky, MD, MSc, DFAPA, Principal investigator, Family Health Centers of San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750537
- Sponsor's protocol ID
- T32CF4745
- Acronym
- EMPACT-Us
- Status last verified
- Sep 2023
- First submitted
- 7 Feb 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31422986Flocke 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.
PubMed 32705473Fernandez 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.
PubMed 32000812Fiore 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.
PubMed 31089727Levinson 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.
PubMed 26155841Ramirez 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.
PubMed 39695566
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use in Low-Income Patients
- ClinicalTrials.gov ID
- NCT05750537
- Acronym / sponsor ID
- EMPACT-Us / T32CF4745
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco Use Cessation, FQHC, San Diego, Electronic Health Record, EHR, Kick It California, FHCSD, UCSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,496 participants (estimated)
- Lead sponsor
- Family Health Centers of San DiegoUniversity, hospital or other
- Collaborators
- University of California, San Diego, Tobacco Related Disease Research Program
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EMPACT-Us | Experimental | Behavioral: EMPACT-UsAn innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study. |
| Newly-enhanced usual care (EUC) | No intervention | –Newly-enhanced usual care (EUC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Current tobacco user
- 18 years old
- Speaks English or Spanish
- Nationality
- Mental health status
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- Patients with a lung cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPACT-UsA suite of tobacco cessation services supported by patient navigation designed in close partnership with patients, providers, and community stakeholders. | Behavioural | EMPACT-Us |
Primary outcome
Engagement with tobacco-use treatment as captured through Electronic Health Record queries
Time frame: 7 to 35 months
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.
Tobacco-use quit attempts as assessed through Electronic Health Record queries
Time frame: 7 to 35 months
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)?))
Biochemically verified tobacco-use cessation as assessed through cotinine saliva test
Time frame: 6 and 12 months
Tobacco-use cessation is defined as prolonged abstinence at the 6- and 12- month follow periods, biochemically verified through cotinine saliva tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 31422986Flocke 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.
- Background: PubMed 32705473Flocke 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.
- Background: PubMed 32000812Fernandez 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.
- Background: PubMed 31089727Fiore 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.
- Background: PubMed 26155841Levinson 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.
- Derived from this study: PubMed 39695566Ramirez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Strong, BA, MS, PhD principal investigator
University of California, San Diego
Karim Ghobrial-Sedky, MD, MSc, DFAPA principal investigator
Family Health Centers of San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPACT-Us in people with Tobacco Use Cessation, run by Family Health Centers of San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Strong, BA, MS, PhD (858-657-5241, dstrong@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with tobacco-use treatment as captured through Electronic Health Record queries (time frame: 7 to 35 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750537, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.