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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EMPACT-Us for smoking cessation?

The EMPACT-Us treatment may be effective because similar approaches, like using patient navigators and nicotine replacement therapy (NRT), have shown promise in helping people quit smoking, especially among low-income smokers. Additionally, mobile phone-based support has been found to double quitting rates, suggesting that combining these strategies could enhance success in smoking cessation. ^{1 2 3 4 5}

Is the Proactive Navigator-Assisted Cessation Program for Smoking Cessation safe for humans?

The research articles provided do not contain specific safety data for the Proactive Navigator-Assisted Cessation Program or its related names. However, they discuss various smoking cessation methods, including nicotine replacement therapies, which are generally considered safe for human use when following guidelines. ^{1 3 6 7 8}

How is the EMPACT-Us treatment different from other smoking cessation treatments?

The EMPACT-Us treatment is unique because it combines proactive navigator assistance with smoking cessation strategies, focusing on socioeconomically disadvantaged individuals who face chronic and acute stressors. This approach is different from traditional methods as it uses community-based navigators to improve adherence and support, which is not commonly found in other smoking cessation programs. ^{1 2 9 10 11}

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

Eligibility Criteria

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

I speak English or Spanish.

Exclusion Criteria

I have been diagnosed with lung cancer.

Pregnant or breastfeeding women

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes and cost-effectiveness of two nicotine replacement treatment delivery models for a tobacco quitline. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A Pilot Study of Nicotine Replacement Therapy Sampling and Selection to Increase Medication Adherence in Low-Income Smokers. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Effectiveness of proactive and reactive services at the Swedish National Tobacco Quitline in a randomized trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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