Smoking Cessation Interventions for Quitting Smoking

Recruiting at 2 trial locations

Overseen By Steven Fu, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Cognitive impairment, Legal guardianship, others

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

Compensation: Varies

Number of Visits: 7

Duration: 9 months

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people of color who smoke quit by testing different ways to connect them with support services. It will compare two approaches: Longitudinal Proactive Outreach (LPO), which offers regular follow-ups and tailored support calls, and Ask-Advice-Connect (AAC), which provides enhanced regular care. The trial focuses on individuals who have smoked at least once in the last month and are part of the Hennepin Healthcare or MCHS system. Participants should be able to communicate in English or Spanish and have their contact information listed in their health records.

As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that may improve smoking cessation support for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Ask-Advice-Connect (AAC) approach is generally safe and well-tolerated. Studies have found it effectively helps smokers connect with treatment services, such as quitlines and nicotine replacement therapy, without major safety concerns. This method primarily involves advising smokers to quit and linking them to resources, which is considered low-risk.

Similarly, Longitudinal Proactive Outreach (LPO) safely increases participation in smoking cessation programs. Research indicates that LPO can successfully reach smokers who might not seek help independently. This approach includes regular follow-ups to encourage quitting, without significant negative effects.

Both AAC and LPO support people who want to quit smoking, and both have been studied in various settings with no major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these smoking cessation interventions because they offer a new approach by combining Ask-Advice-Connect (AAC) with Longitudinal Proactive Outreach (LPO). Unlike standard care, which often relies on brief counseling and nicotine replacement therapy, the AAC + LPO approach provides ongoing, personalized support through motivational interviewing calls at key intervals—baseline, 3, 6, and 9 months post-enrollment. This ongoing support aims to keep participants engaged and motivated to quit smoking over the long term, potentially increasing success rates compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation among BIPOC populations?

Research has shown that the Ask-Advice-Connect (AAC) approach, which participants in this trial may receive, can significantly increase enrollment in smoking cessation programs. One study found that direct connection to the Quitline resulted in enrollment rates 13 times higher than traditional methods. Additionally, about 16.6% of participants reported quitting smoking after six months.

The Longitudinal Proactive Outreach (LPO), another treatment option in this trial, has also helped more people quit smoking, particularly those who are hard to reach. This proactive approach has been linked to higher quit rates among individuals from various economic backgrounds and has effectively encouraged smokers from disadvantaged groups to use cessation treatments. These findings suggest that both AAC and LPO could be promising methods to help people stop smoking. ^{3 4 6 7 8}

Who Is on the Research Team?

Steven Fu, MD, MSCE

Principal Investigator

Minneapolis Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for BIPOC individuals who are part of the Hennepin Healthcare or MCHS system, speak English or Spanish, currently smoke cigarettes, and want to quit. They must have contact information in their health record. People with cognitive impairments or under legal guardianship, or those who've opted out of research can't participate.

Inclusion Criteria

English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey

Currently smoke more than 1 cigarette over the past 30 days

Must have address or telephone number in the electronic health record

Exclusion Criteria

I have chosen not to participate in any research studies.

My health records show I have cognitive issues or I am under legal guardianship.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment, with enhanced access to State Quitline and Nicotine Replacement Therapy

9 months

4 visits (virtual)

Follow-up

Participants are monitored for smoking abstinence and quality of life changes

9 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Ask-Advice-Connect (AAC)
• Longitudinal Proactive Outreach (LPO)

Trial Overview

The study tests two methods to help BIPOC smokers quit: Ask-Advice-Connect (AAC) and Longitudinal Proactive Outreach (LPO). It aims to see if proactive outreach using these methods increases the use of evidence-based cessation treatments compared to standard care.

How Is the Trial Designed?

Group I: AAC + Longitudinal Proactive Outreach (LPO) Experimental Treatment 2 Interventions

AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.

Group II: Enhanced Usual Care: Ask-Advice-Connect (AAC) Active Control 1 Intervention

AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.

Ask-Advice-Connect (AAC) is already approved in United States for the following indications:

Approved in United States as Ask-Advice-Connect for:

• Tobacco cessation

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The Ask-Advise-Connect (AAC) approach effectively linked 12% of current smokers at a Federally Qualified Health Center to Quitline services, demonstrating its potential to enhance smoking cessation efforts in low-socioeconomic status communities.

Post-implementation feedback from clinic staff indicated that AAC was easy to implement and positively impacted patient care, suggesting it could become a standard practice for smoking cessation in similar healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of ask-advise-connect in a federally qualified health center: a mixed methods evaluation using the re-aim framework. Shorey Fennell, B., Cottrell-Daniels, C., Hoover, DS., et al.[2023]

A proactive approach to smoking cessation using motivational interviewing (MI) significantly increased the number of smokers receiving counseling in hospitals, with 87% of smokers receiving intervention compared to only 22% in a reactive approach.

While the proactive strategy showed a trend towards increased smoking cessation rates at 12 months (from 43% to 51%), the difference was not statistically significant, indicating potential benefits that may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and efficacy of a systematic intensive smoking cessation intervention using motivational interviewing for smokers hospitalised for an acute coronary syndrome: a multicentre before-after study with parallel group comparisons. Auer, R., Gencer, B., Tango, R., et al.[2022]

The implementation of the Ask-Advise-Connect (AAC) method in a rural Tennessee clinic led to a smoking cessation rate of 12.5% among participants, which is above the national average for smoking cessation programs.

Over a 4-month period, the clinic provided 102 counseling visits, and 21% of participants reported a significant decrease in cigarette consumption, highlighting the potential effectiveness of workplace cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Cessation and Referral to the National Quitline. Blocker, J., Lazear, J., Ridner, SL.[2020]

Proactive telephone counseling for smoking cessation has been shown to significantly increase cessation rates, with pooled odds ratios of 1.34 for short-term and 1.20 for long-term follow-ups based on 13 randomized trials.

Reactive approaches, like help lines, attract fewer smokers but can still be effective public interventions, especially when promoted, highlighting the importance of both proactive and reactive strategies in smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Lichtenstein, E., Glasgow, RE., Lando, HA., et al.[2019]

Using a local area code for proactive phone outreach significantly increased the consent rate for quitline referrals among low-income smokers, with a prevalence ratio of 1.29, indicating that familiarity may enhance engagement.

The study found that younger smokers (under 61 years) and Spanish-speaking individuals were more likely to consent to quitline referrals, suggesting that targeted outreach strategies could be particularly effective for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Proactive Outreach Strategy Using a Local Area Code to Refer Unassisted Smokers in a Safety Net Health System to a Quitline: A Pragmatic Randomized Trial. Valencia, CV., Dove, MS., Cummins, SE., et al.[2023]

Current referral workflows for Quitline services in Community Health Centers are inefficient and inconsistent, leading to missed opportunities for tobacco cessation support.

An optimal electronic health record (EHR)-based workflow was designed to standardize the Ask-Advice-Connect (AAC) intervention, allowing for electronic referrals and improved communication between clinics and Quitlines, which could enhance the effectiveness of tobacco cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workflow analysis for design of an electronic health record-based tobacco cessation intervention in community health centers. Gibson, B., Kramer, H., Weir, C., et al.[2023]

Proactive outreach models for tobacco treatment can significantly enhance access and effectiveness, especially for individuals with low motivation to quit, compared to traditional reactive models that only serve those actively seeking help.

The proposed comprehensive model for proactive outreach emphasizes the importance of identifying populations, offering treatment, and delivering care, which could lead to improved data reporting and better patient outcomes in tobacco cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposing a Model of Proactive Outreach to Advance Clinical Research and Care Delivery for Patients Who Use Tobacco. Burris, JL., Borger, TN., Baker, TB., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3858085/

Ask Advise Connect: A New Approach to Smoking ...

Directly connecting smokers to the Quitline resulted in a 13-fold increase in cessation treatment enrollment when compared to the nationally recommended method ...

2.

academic.oup.com

academic.oup.com/tbm/article/10/1/163/5198988

quitline treatment engagement and smoking cessation outcomes

Self-reported abstinence at 6 months was 16.6%, and biochemically confirmed abstinence was 4.5%. AAC was successfully implemented as part of ...

3.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/1656544

Ask-Advise-Connect: A New Approach to Smoking ...

Directly connecting smokers to the quitline resulted in a 13-fold increase in cessation treatment enrollment when compared with the nationally ...

4.

substanceabusepolicy.biomedcentral.com

substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-023-00535-0

Implementation of ask-advise-connect for smoking cessation ...

The Ask-Advise-Connect (AAC) approach can help primary care providers to increase the number of people who attempt to quit smoking and enrol into cessation ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211335519300038

Quitline treatment dose predicts cessation outcomes ...

Most smokers received minimal or no treatment, and treatment dose had a large impact on abstinence. Results highlight the importance of improving engagement in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4023543/

Efficacy of Ask Advise Connect in a Safety Net Healthcare ...

A strength is that AAC was evaluated in a setting representative of real-world healthcare systems that serve smokers disproportionately burdened by tobacco.

7.

ajpmonline.org

ajpmonline.org/article/S0749-3797(13)00488-1/abstract

The Ask–Advise–Connect Approach for Smokers in a ...

The U.S. Public Health Service recommends that all patients be asked about their smoking at every visit and that smokers be given brief advice to quit and ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0749379713004881

The Ask–Advise–Connect Approach for Smokers in a ...

This study evaluated the efficacy of the Ask–Advise–Connect (AAC) approach to linking smokers with treatment in a large, safety net public healthcare system.