Proactive Navigator-Assisted Cessation Program for Smoking Cessation

(EMPACT-Us Trial)

Recruiting at 1 trial location

Overseen By Karim Ghobrial-Sedky, MD, MSc, DFAPA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Family Health Centers of San Diego

Disqualifiers: Pregnancy, Breastfeeding, Lung cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

13496 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called EMPACT-Us (Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use) to help people quit smoking more effectively. It aims to improve engagement with tobacco treatments, increase quit attempts, and maintain smoke-free status for up to a year. Participants will either try the EMPACT-Us program or continue with usual care to determine which is more effective. The trial seeks current tobacco users who speak English or Spanish and are not pregnant or breastfeeding. As an unphased trial, participants contribute to innovative research that may enhance future smoking cessation programs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on tobacco cessation, so it's best to ask the study team for guidance.

What prior data suggests that the EMPACT-Us program is safe for smoking cessation?

Research shows that the EMPACT-Us program helps people quit smoking by offering various support services. Patients, healthcare providers, and community members contributed to its creation. Although specific safety data for EMPACT-Us is unavailable, it is important to note that this program is not a drug or medical treatment. Instead, it provides support to help people stop using tobacco.

As a behavioral program rather than a medication, EMPACT-Us is generally expected to be safe for participants. No reports of negative effects have been linked to this type of support service, suggesting that EMPACT-Us should be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive Navigator-Assisted Cessation Program because it offers a fresh approach to helping people quit smoking. Unlike traditional methods like nicotine replacement therapy or prescription medications, this program, known as EMPACT-Us, is a comprehensive suite of services created with input from patients, healthcare providers, and community stakeholders. This collaborative development ensures that the program is tailored to meet the specific needs of its users, potentially increasing its effectiveness. By combining personalized support with community engagement, EMPACT-Us aims to provide a more holistic and supportive pathway to smoking cessation.

What evidence suggests that EMPACT-Us is effective for smoking cessation?

Research shows that the EMPACT-Us program, a treatment option in this trial, is a promising new service to help people stop smoking. In earlier studies, developers created the program with input from both patients and healthcare providers, making it more suited to real needs. This approach could lead to better participation and more successful quit attempts compared to standard methods. Early results suggest that EMPACT-Us may enhance the use of proven treatments, possibly leading to better long-term success in quitting smoking. Although data on its effectiveness in people remains limited, the program's collaborative design is expected to improve its success in helping people quit smoking. ^{1 2 3 4 5}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for current tobacco users who are at least 18 years old, of any ethnicity, race, nationality, sexual orientation or mental health status. They must speak English or Spanish and have met level 1 criteria for inclusion. It's not open to those with lung cancer or pregnant/breastfeeding women.

Inclusion Criteria

Current tobacco user

No exclusions due to nationality

No exclusions due to mental health status

Exclusion Criteria

Pregnant or breastfeeding women

I have been diagnosed with lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 months

Milestone 1: Startup and Training

Startup and training including TE Coach curriculum adaptation, MA training, PCP training, and baseline data collection

6 months

Multiple visits for training and data collection

Milestone 2: Testing of EMPACT-Us

Testing of EMPACT-Us suite of services with evaluation and fidelity checks

27 months

Regular visits for service testing and evaluation

Follow-up

Participants are monitored for engagement and cessation outcomes

7 to 35 months

Ongoing monitoring through EHR queries and surveys

Milestone 5: Manuscript Preparation and Dissemination

Preparation and dissemination of study findings

6 to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• EMPACT-Us

Trial Overview The study tests EMPACT-Us, a set of services designed to help low-income patients quit smoking. Its effectiveness will be compared against enhanced usual care by measuring engagement in treatments and verified cessation rates at 6 and 12 months.

How Is the Trial Designed?

Group I: EMPACT-Us Experimental Treatment 1 Intervention

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

Group II: Newly-enhanced usual care (EUC) Active Control 1 Intervention

Newly-enhanced usual care (EUC)

EMPACT-Us is already approved in United States for the following indications:

Approved in United States as EMPACT-Us for:

• Tobacco cessation

Who Is Running the Clinical Trial?

Family Health Centers of San Diego

Lead Sponsor

Trials

9

Recruited

15,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Published Research Related to This Trial

Proactive telephone counseling significantly enhances the effectiveness of minimal interventions for smoking cessation, as shown in a meta-analysis of 22 studies published between 1990 and 2003.

The effectiveness of this counseling varies based on factors such as the year of publication, follow-up duration, participant age, gender, readiness to quit, and smoking habits, indicating that tailoring interventions to specific participant characteristics can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive telephone counseling as an adjunct to minimal intervention for smoking cessation: a meta-analysis. Pan, W.[2006]

A pilot study involving 40 socioeconomically disadvantaged smokers showed that using smoking cessation treatment navigators significantly increased the use of evidence-based cessation treatments, with 71% of participants starting nicotine replacement therapy.

The intervention was well-received, with high satisfaction ratings and a self-reported abstinence rate of 21%, suggesting that this community-based approach could effectively support smoking cessation efforts among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. Levinson, AH., Valverde, P., Garrett, K., et al.[2023]

The study evaluated the Minnesota QUITPLAN Helpline's shift from a single eight-week shipment of nicotine replacement therapy (NRT) to a two-shipment protocol, finding that satisfaction rates were higher among participants receiving more NRT and counseling, but this did not translate to higher quit rates.

Despite increased satisfaction and more counseling calls in the two-shipment group, there were no significant differences in 30-day quit rates among the different NRT distribution protocols, suggesting that while participant experience improved, the effectiveness of the interventions remained similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and cost-effectiveness of two nicotine replacement treatment delivery models for a tobacco quitline. Saul, JE., Lien, R., Schillo, B., et al.[2021]

Computer-based smoking cessation programs are effective and can be delivered on a large scale at a low cost, making them accessible to many smokers.

These programs work best when combined with pharmacotherapy and can serve as a helpful addition to counseling provided by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. Etter, JF.[2017]

The iCanQuit smartphone app significantly outperformed the QuitGuide app in helping participants quit smoking, achieving a 34% quit rate compared to 20% for QuitGuide among those using FDA-approved cessation medications.

Using nicotine replacement therapy (NRT) alongside the iCanQuit app led to even higher quit rates of 40%, suggesting that combining the app with cessation medications can enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial. Bricker, JB., Santiago-Torres, M., Mull, KE., et al.[2023]

In a study involving 2,054 smokers from a Veterans Affairs Medical Center, various smoking cessation interventions were tested over 30 months, showing that stage-matched manuals alone achieved a cessation rate of 20.3%.

Adding nicotine replacement therapy (NRT) and other expert or automated counseling methods did not significantly improve cessation rates compared to the manuals alone, indicating that the effectiveness of these additional interventions may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. Velicer, WF., Friedman, RH., Fava, JL., et al.[2019]

Nicotine-assisted reduction programs can effectively motivate unwilling quitters by providing nicotine replacement, allowing for flexible quit attempts over an extended period, which can last more than a year.

The proposed outcome measure of 'floating prolonged abstinence' would better capture the success of quit attempts made during treatment, rather than relying on fixed follow-up points, making it more suitable for evaluating the effectiveness of cessation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence. Aveyard, P., Wang, D., Connock, M., et al.[2022]

A randomized controlled trial involving 586 participants found no significant difference in smoking cessation outcomes between the high-intensity proactive service and the low-intensity reactive service of the Swedish National Tobacco Quitline after 12 months.

Both services achieved similar rates of point prevalence (27%) and continuous abstinence (21%) when including non-responders as smokers, suggesting that the reactive service could be a more resource-efficient option for tobacco cessation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of proactive and reactive services at the Swedish National Tobacco Quitline in a randomized trial. Nohlert, E., Ohrvik, J., Helgason, AR.[2021]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

The txt2stop trial demonstrated that mobile-phone-based smoking cessation support significantly increases quitting rates, with an estimated cost of £278 per additional quitter, making it a cost-effective intervention.

Incorporating future healthcare savings from reduced smoking-related diseases, the text-based support not only improves health outcomes, gaining 18 life years and 29 quality-adjusted life years per 1,000 smokers, but is also projected to be cost-saving for the NHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop. Guerriero, C., Cairns, J., Roberts, I., et al.[2022]

A pilot study involving 83 participants found that a novel experiential approach to nicotine replacement therapy (NRT) sampling was feasible and acceptable for low-income smokers, showing promise in increasing medication adherence.

The experiential intervention led to higher adherence and improvements in smoking behavior compared to the gold standard treatment, although it had greater participant drop-out rates, indicating the need for further research on a larger scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Nicotine Replacement Therapy Sampling and Selection to Increase Medication Adherence in Low-Income Smokers. Cropsey, KL., Wolford-Clevenger, C., Sisson, ML., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05750537

Study Details | NCT05750537 | Enhanced Multicomponent ... We hypothesize that EMPACT-Us will be more effective than the newly-enhanced usual care on improving engagement in tobacco treatments, quit attempts and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39695566/

Assessing the effects of Enhanced Multicomponent ... This study will examine if the enhanced suite of services offers insights on how to best integrate evidence-based tobacco treatment services into usual care.

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20997-6

Assessing the effects of Enhanced Multicomponent Proactive ... This study will examine if the enhanced suite of services offers insights on how to best integrate evidence-based tobacco treatment services into usual care.

4. researchgate.net researchgate.net/publication/387184958_Assessing_the_effects_of_Enhanced_Multicomponent_Proactive_Navigator-Assisted_Cessation_of_Tobacco_Use_within_a_federally_qualified_health_center_EMPACT-Us_a_protocol_study

(PDF) Assessing the effects of Enhanced Multicomponent ... Assessing the effects of Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use within a federally qualified health ...

5. withpower.com withpower.com/trial/phase-tobacco-use-cessation-2-2023-66ef4

Proactive Navigator-Assisted Cessation Program for Smoking ... This research study is being conducted to test the effectiveness of the Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use (EMPACT-Us) ...