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OpenTrials
Completed

NCT Number: NCT04462289

Electronic Proactive Outreach for Smokers With COPD

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, the investigators will adapt a clinically available motivational texting program 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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Smoking Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

About this study

Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory conditions and the 4th leading cause of death in the US. 90% of cases are directly attributable to smoking. Quitting smoking is the most important intervention for these patients, who continue to smoke at rates double the national average. Smokers with COPD remain undertreated for tobacco use. Proactive tobacco treatment programs identify patients outside of a routine clinic visit, engage them in making a quit attempt and connect them with treatment. These programs may be particularly beneficial for smokers with COPD. Previous phone-based programs are resource intensive to deliver. Electronic methods for delivering proactive outreach for tobacco cessation may be effective and cost-effective, and can be tailored to the target population.

Hypothesis: A proactive tobacco treatment program delivered electronically and tailored to smokers with COPD will be effective and cost effective for increasing quit engagement among smokers with COPD.

Study design: Multi-aim implementation study with randomized pilot. Aim 1: Mixed methods (survey and interview) assessment of current use of health information technology among smokers with COPD with a focus on the impact of the chronic disease state on tobacco cessation.

Aim 2: Qualitative assessment of barriers and facilitators to implementation of proactive tobacco treatment programs for patients with COPD among staff and leadership.

Aim 3: Randomized pilot of a proactive tobacco treatment program for smokers with COPD delivered through text messaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans active in clinical care (at least one primary care or pulmonary visit within the past year)
  • Past-year smoking status in the electronic health record indicating current smoking, confirmed on enrollment call
  • Diagnosed with COPD (2 International Classification of Diseases (ICD)-10 diagnoses of COPD within the past 2 years)
  • Currently enrolled in MyHealtheVet secure messaging

Exclusion criteria

  • Already enrolled in behavioral VA tobacco treatment
  • Enrolled in hospice
  • Undergoing active cancer treatment
  • Advanced dementia
  • Unable to communicate in English

Treatment and study plan

Proactive outreach

Behavioral

Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs

Primary outcomes

  1. Participation in Tobacco Cessation Treatment

    Time frame: 6 months

    Any participation in tobacco cessation treatment (medication use, counseling)

Secondary outcomes

  1. 30-Day Abstinence

    Time frame: 6 months

    Number of participants who had not smoked any cigarettes in the past 30 days

  2. Quit or Cut Down

    Time frame: 6 months

    Number of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency

  3. 7-day Abstinence

    Time frame: 6 months

    Count of participants who have not smoked in the past 7 days

  4. Moved Upward on the Quit Ladder

    Time frame: 6 months

    Count of participants who indicated that they were more interested in quitting smoking than at baseline

  5. Cut Down in Heaviness of Smoking

    Time frame: 6 months

    Cut down by 10 cigarettes per day or in frequency of smoking from daily to some days

  6. Care Coordination

    Time frame: 60 days

    Proportion of participants who completed a care coordination call

  7. Number of Quit Attempts

    Time frame: 6 months

    Self-reported attempts to quit smoking

  8. Types of Assistance Used

    Time frame: 6 months

    count of the types of assistance participants used

  9. Medications Used

    Time frame: 6 months

    count of participant split by tobacco treatment medications used during quit attempts

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2020
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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