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 project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.

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 the Ask-Advice-Connect (AAC) method safe for humans?

The Ask-Advice-Connect (AAC) method is generally considered safe for humans as it involves counseling and connecting individuals to quitlines for tobacco cessation, which are standard practices in healthcare settings. There are no reports of adverse effects related to the AAC method in the available research. ^{1 2 3 4 5}

How is the Ask-Advice-Connect (AAC) treatment for smoking cessation different from other treatments?

The Ask-Advice-Connect (AAC) treatment is unique because it involves proactive outreach, connecting individuals directly to a quitline, which is a phone-based support service, as part of a workplace cessation program. This approach is different from traditional methods that rely on individuals to seek help themselves, and it has shown higher success rates in encouraging people to quit smoking. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Ask-Advice-Connect (AAC) for quitting smoking?

The Ask-Advice-Connect (AAC) method showed a 12.5% smoking cessation rate in a workplace program, which is above the national average, indicating its potential effectiveness. Additionally, proactive outreach strategies, like AAC, can increase access to tobacco treatment and improve quit rates by encouraging attempts among less motivated individuals. ^{1 2 3 5 7}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. England 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. [2023]

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

Tobacco Cessation and Referral to the National Quitline. [2020]

3. England 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. [2022]

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

Proposing a Model of Proactive Outreach to Advance Clinical Research and Care Delivery for Patients Who Use Tobacco. [2023]

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

Workflow analysis for design of an electronic health record-based tobacco cessation intervention in community health centers. [2023]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. [2019]