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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Randomly assigned sample who will receive usual care for tobacco cessation treatment | |
| Proactive Outreach | Experimental | Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in Tobacco Cessation Treatment | Any participation in tobacco cessation treatment (medication use, counseling) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day Abstinence | Number of participants who had not smoked any cigarettes in the past 30 days | 6 months |
| Quit or Cut Down | Number of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne C. Melzer, MD MS | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | United States |
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Eligible participants were identified using the electronic health record (EHR) with: 2 or more ICD-10 codes for COPD in the past 2 years at any VA healthcare system, along with a visit to primary care or pulmonary medicine at the Minneapolis VA Health Care System with in the past 18 months, and their last tobacco assessment indicated current smoking. Participants were excluded if they were enrolled in hospice, a malignancy, had advanced dementia, enrolled in a tobacco treatment program.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Randomly assigned sample who will receive usual care for tobacco cessation treatment |
| FG001 | Proactive Outreach | Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program. Proactive Outreach: Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Randomly assigned sample who will receive usual care for tobacco cessation treatment |
| BG001 | Proactive Outreach | Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program. Proactive Outreach: Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participation in Tobacco Cessation Treatment | Any participation in tobacco cessation treatment (medication use, counseling) | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Randomly assigned sample who will receive usual care for tobacco cessation treatment |
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This was a small, single center pilot including mostly white, male Veterans. Results may therefore not be generalizable to other settings. However, this is a group expected to be particularly refractory to treatment. We chose to make relatively moderate adaptations to an existing protocol and there may have been other areas that would have benefitted from further tailoring. Outcomes were relatively short and measured by self-report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Melzer | Minneapolis VA Health Care System | 6124674413 | anne.melzer2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | May 2, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2023 | Jul 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Patient-level randomized pilot
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| 6 months |
| 7-day Abstinence | Count of participants who have not smoked in the past 7 days | 6 months |
| Moved Upward on the Quit Ladder | Count of participants who indicated that they were more interested in quitting smoking than at baseline | 6 months |
| Cut Down in Heaviness of Smoking | Cut down by 10 cigarettes per day or in frequency of smoking from daily to some days | 6 months |
| Care Coordination | Proportion of participants who completed a care coordination call | 60 days |
| Number of Quit Attempts | Self-reported attempts to quit smoking | 6 months |
| Types of Assistance Used | count of the types of assistance participants used | 6 months |
| Medications Used | count of participant split by tobacco treatment medications used during quit attempts | 6 months |
| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Rurality | Count of Participants | Participants |
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| Education Attainment | Count of Participants | Participants |
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| Cigarettes per Day | Count of Participants | Participants |
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| Past Year Quit Attempts | Count of Participants | Participants |
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| No particular timeframe to Quit | Count of Participants | Participants |
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| Heaviness of Smoking Index | This is a calculated scale that measures nicotine dependence using two questions: how soon after waking do you smoke your first cigarette and cigarettes per day. Scores range from 0-6. Lower numbers correspond with lower nicotine dependence. Question 1: Time to First Cigarette After waking: 6-30 min: 3 pts 31-60 min: 2 pt after 60 min: 0 pt Question 2: Cigarettes per day 10 or fewer: 0 pt 11-20: 1 pt 21-30: 2pt 31+ : 3pt calculated by adding points from each question Dependence level: low: 0-2 pt medium: 3-4 pts High: 5-6 pts | Mean | Standard Deviation | units on a scale |
|
| Quit Ladder | Count of Participants | Participants |
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| Use of Texting Every Day | Count of Participants | Participants |
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| Secondary | 30-Day Abstinence | Number of participants who had not smoked any cigarettes in the past 30 days | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Quit or Cut Down | Number of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 7-day Abstinence | Count of participants who have not smoked in the past 7 days | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Moved Upward on the Quit Ladder | Count of participants who indicated that they were more interested in quitting smoking than at baseline | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Cut Down in Heaviness of Smoking | Cut down by 10 cigarettes per day or in frequency of smoking from daily to some days | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Care Coordination | Proportion of participants who completed a care coordination call | Posted | Count of Participants | Participants | 60 days |
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| Secondary | Number of Quit Attempts | Self-reported attempts to quit smoking | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Types of Assistance Used | count of the types of assistance participants used | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Medications Used | count of participant split by tobacco treatment medications used during quit attempts | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Proactive Outreach | Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program. Proactive Outreach: Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs | 3 | 83 | 0 | 83 | 0 | 83 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D015438 | Health Behavior |
| Cessation Clinic or Texting/App Alone |
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| Did not use tobacco cessation assistance |
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| Varenicline |
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| Bupropion |
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| did not use medication |
|