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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases, with 90% of cases directly attributable to smoking. Unfortunately, many patients continue to smoke and have an urgent need to quit. Proactive tobacco treatment programs identify patients outside of a routine clinical appointment and engage them in making a supported quit attempt. Most previous research of proactive tobacco treatment has used telephone outreach, which can be resource intensive. Electronic methods (texting, secure messaging) may be effective while requiring fewer resources. In this study, a previously tested telephone outreach intervention will be adapted for electronic delivery, with content tailored to smokers with COPD. First, information will be gathered from smokers with COPD and the medical staff who care for them to adapt the program for electronic delivery. Then, the program will be pilot-tested. Smokers with COPD will be randomly assigned to either usual medical care or the outreach intervention, with goals to increase participation in smoking cessation programs, quit attempts, and successful cessation.

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 data supports the effectiveness of the treatment Proactive Outreach for COPD?

Research shows that smoking cessation is the most effective way to slow down COPD progression and improve quality of life. Combining counseling with treatments like nicotine replacement therapy has been shown to significantly help people quit smoking, which is crucial for managing COPD. ^{1 2 3 4 5}

Is the Proactive Tobacco Treatment for COPD safe for humans?

Research shows that nicotine gum, nicotine nasal spray, and bupropion, which are used in smoking cessation therapies, have a good safety profile for people with COPD. These treatments have similar side effects to those experienced by healthy smokers, indicating they are generally safe for human use. ^{6 7 8 9 10}

How is the Proactive Outreach treatment for COPD different from other treatments?

Proactive Outreach is unique because it actively reaches out to patients, even those with low motivation to quit smoking, rather than waiting for them to seek help. This approach aims to increase access to tobacco treatment, address health disparities, and improve quit rates by using a combination of human interaction and technology. ^{1 2 3 11 12}

Research Team

Anne C Melzer, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Smoking Cessation Strategies for Patients with COPD. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Medical help for smorking cessation: the pneumologist's point of view]. [2006]

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

Smoking Cessation/Vaccinations. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in COPD: a network meta-analysis of randomised trials. [2013]

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

Smoking cessation. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Benefits and risks of pharmacological smoking cessation therapies in chronic obstructive pulmonary disease. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

[Smoking cessation for COPD]. [2018]

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

New developments in approaches to smoking cessation. [2019]

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

Effect of smoking status on lung function, patient-reported outcomes, and safety among patients with COPD treated with indacaterol/glycopyrrolate: Pooled analysis of the FLIGHT1 and FLIGHT2 studies. [2020]

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

Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. [2022]

11. 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]

12. 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]