Proactive Tobacco Treatment for COPD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Behavioral tobacco treatment, Hospice, Cancer, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with chronic obstructive pulmonary disease (COPD) quit smoking through a motivational texting program. Researchers seek to determine if electronic methods like texting can effectively support smoking cessation compared to usual care. Participants will be randomly assigned to one of two groups: one receiving standard care and the other receiving proactive outreach with motivational texts. Veterans with COPD who are current smokers and use the MyHealtheVet secure messaging system are ideal candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for quitting smoking.

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 smoking cessation for people with COPD.

What prior data suggests that this proactive outreach is safe for smokers with COPD?

Research has shown that programs like the one being studied to help people quit smoking are generally safe. The side effects typically resemble those experienced by healthy smokers, indicating that most people, including those with chronic obstructive pulmonary disease (COPD), can tolerate them well. Overall, studies have not identified any serious safety issues, making this treatment a viable option for those wanting to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about proactive outreach for tobacco treatment in COPD patients because it offers a fresh approach compared to traditional methods. Most existing treatments rely on patients actively seeking help, often involving medications like nicotine replacement therapy or counseling. Proactive outreach flips the script by directly offering support and connecting patients to a motivational texting program, helping them quit smoking more effectively. This method is promising because it actively engages patients, potentially increasing their chances of quitting tobacco successfully.

What evidence suggests that this proactive outreach is effective for COPD?

Research shows that reaching out to smokers with COPD can help them quit smoking more effectively. In this trial, participants in the Proactive Outreach arm will receive a proactive offer of tobacco treatment, connected to a motivational texting program. Studies have found that smokers with chronic lung diseases, like COPD, often respond well to programs that actively offer support to quit smoking, rather than waiting for them to ask for help. Electronic methods, such as texting, are considered effective and require fewer resources. Doctors believe this proactive approach could effectively help COPD patients stop smoking. These findings suggest that reaching out to smokers with COPD could benefit those looking to quit. ^{1 6 7 8 9}

Who Is on the Research Team?

Anne C Melzer, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for smokers with COPD who are veterans, currently enrolled in MyHealtheVet secure messaging, have had at least one medical visit in the past year, and are confirmed as current smokers. It's not for those already in VA tobacco treatment, non-English speakers, hospice patients, cancer patients under active treatment or individuals with advanced dementia.

Inclusion Criteria

You have been identified as a current smoker in your medical records within the past year.

Currently enrolled in MyHealtheVet secure messaging

I have been diagnosed with COPD twice in the last 2 years.

Exclusion Criteria

I am currently receiving treatment for cancer.

I cannot communicate in English.

You are currently receiving end-of-life care in a hospice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Adaptation

Information gathered from smokers with COPD and medical staff to adapt the program for electronic delivery

4 weeks

Pilot Testing

Randomized pilot of a proactive tobacco treatment program delivered through phone and text messaging

60 days

Follow-up

Participants are monitored for participation in tobacco cessation treatment and smoking cessation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Proactive Outreach

Trial Overview

The study is testing an electronic proactive outreach program designed to help smokers with COPD quit smoking. The program will be delivered via text or secure messaging instead of phone calls. Participants will either receive usual care or the new intervention to see if it increases engagement in quitting programs and success rates.

How Is the Trial Designed?

Group I: Proactive Outreach Experimental Treatment 1 Intervention

Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.

Group II: Usual Care Active Control 1 Intervention

Randomly assigned sample who will receive usual care for tobacco cessation treatment

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

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]

New nicotine delivery systems, including a nasal spray and inhaler, have been shown to effectively reduce cravings and withdrawal symptoms, leading to improved cessation rates compared to placebo.

Nicotine replacement therapies like patches and gum are now available over-the-counter, and new safety data suggest they pose little additional risk for high-risk groups such as adolescents, pregnant women, and individuals with serious cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in approaches to smoking cessation. Jorenby, DE.[2019]

In a study involving 504 patients with mild to moderate COPD, varenicline was found to be significantly more effective than placebo for smoking cessation, with a continuous abstinence rate of 42.3% compared to 8.8% after 12 weeks.

The safety profile of varenicline was consistent with previous studies, with common side effects including nausea and insomnia, but serious adverse events were infrequent, indicating it is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Tashkin, DP., Rennard, S., Hays, JT., 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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29144886/

Comparative Effectiveness of Proactive Tobacco Treatment ...

Conclusions: Smokers with chronic lower respiratory disease may be more likely to respond to a proactive outreach intervention for tobacco cessation treatment ...

2.

atsjournals.org

atsjournals.org/doi/10.1513/AnnalsATS.201707-582OC

Comparative Effectiveness of Proactive Tobacco Treatment ...

A total of 3,307 had outcome data with the following assignments to the intervention: proactive care: n = 1,272 without chronic lower ...

3.

clinicaltrial.be

clinicaltrial.be/en/details/176844?per_page=100&only_recruiting=0&only_eligible=0

Electronic Proactive Outreach for Smokers With COPD - Cli...

Electronic methods for delivering proactive outreach for tobacco cessation may be effective and cost-effective, and can be tailored to the ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11306907/

Clinician Views of Proactive Tobacco Treatment Programs

Clinicians in all roles identified that proactive outreach could be an effective use of resources to help patients with COPD who smoke quit with ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/89/NCT04462289/Prot_SAP_001.pdf

Proactive Protocol V2.1 11/20/23 Research ...

Specific Aims/Purpose. Overview: Many patients with chronic obstructive pulmonary disease (COPD) due to smoking continue to smoke. Proactive ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4590783/

Proactive tobacco cessation outreach to smokers of low ...

The intervention was effective in all baseline tobacco use subgroups including those who planned/ did not plan to quit in the next 30 days.

7.

withpower.com

withpower.com/trial/phase-pulmonary-disease-chronic-obstructive-8-2020-be72f

Proactive Tobacco Treatment for COPD · Info for Participants

These treatments have similar side effects to those experienced by healthy smokers, indicating they are generally safe for human use. Show more.

8.

clinicaltrial.be

clinicaltrial.be/en/details/176844?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Electronic Proactive Outreach for Smokers With COPD - Cli...

Smokers with COPD remain undertreated for tobacco use. Proactive tobacco treatment programs identify patients outside of a routine clinic visit, ...

9.

tandfonline.com

tandfonline.com/doi/abs/10.1080/17476348.2022.2108797

Developments in smoking cessation interventions for ...

A scoping review of smoking cessation for COPD patients was conducted by searching the MEDLINE, Embase, and Cochrane Library databases for all studies ...