Pulmonary Disease, Chronic Obstructive, Smoking
Conditions
Keywords
smoking cessation, Pulmonary Disease, Chronic Obstructive, implementation science
Brief summary
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.
Detailed description
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.
Interventions
Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs
Sponsors
Study design
Intervention model description
Patient-level randomized pilot
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation in Tobacco Cessation Treatment | 6 months | Any participation in tobacco cessation treatment (medication use, counseling) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit or Cut Down | 6 months | Number of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency |
| 7-day Abstinence | 6 months | Count of participants who have not smoked in the past 7 days |
| Moved Upward on the Quit Ladder | 6 months | Count of participants who indicated that they were more interested in quitting smoking than at baseline |
| Cut Down in Heaviness of Smoking | 6 months | Cut down by 10 cigarettes per day or in frequency of smoking from daily to some days |
| 30-Day Abstinence | 6 months | Number of participants who had not smoked any cigarettes in the past 30 days |
| Number of Quit Attempts | 6 months | Self-reported attempts to quit smoking |
| Types of Assistance Used | 6 months | count of the types of assistance participants used |
| Medications Used | 6 months | count of participant split by tobacco treatment medications used during quit attempts |
| Care Coordination | 60 days | Proportion of participants who completed a care coordination call |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Randomly assigned sample who will receive usual care for tobacco cessation treatment | 41 |
| 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 | 83 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 3 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Usual Care | Proactive Outreach | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 9.93 | 68.9 years STANDARD_DEVIATION 7.22 | 68.4 years STANDARD_DEVIATION 8.2 |
| Cigarettes per Day 10 or fewer | 16 Participants | 26 Participants | 42 Participants |
| Cigarettes per Day 11 to 20 | 20 Participants | 47 Participants | 67 Participants |
| Cigarettes per Day 21 or more | 5 Participants | 10 Participants | 15 Participants |
| Education Attainment College Graduate/Post-Graduate | 5 Participants | 19 Participants | 24 Participants |
| Education Attainment High School Granduate/GED | 15 Participants | 23 Participants | 38 Participants |
| Education Attainment Less than High School | 2 Participants | 3 Participants | 5 Participants |
| Education Attainment Some College or Vocational Education | 19 Participants | 38 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 75 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 10 Participants |
| Heaviness of Smoking Index | 2.41 units on a scale STANDARD_DEVIATION 1.61 | 2.48 units on a scale STANDARD_DEVIATION 1.42 | 2.46 units on a scale STANDARD_DEVIATION 1.48 |
| No particular timeframe to Quit | 20 Participants | 54 Participants | 74 Participants |
| Past Year Quit Attempts | 27 Participants | 36 Participants | 63 Participants |
| Quit Ladder I don't want to stop/I should stop smoking but don't really want to | 14 Participants | 25 Participants | 39 Participants |
| Quit Ladder I really want to stop smoking and intend to in the next 1 or 3 months | 15 Participants | 17 Participants | 32 Participants |
| Quit Ladder I really want to stop smoking, but I don't know when I will | 6 Participants | 16 Participants | 22 Participants |
| Quit Ladder I want to stop smoking and hope to soon | 2 Participants | 12 Participants | 14 Participants |
| Quit Ladder I want to stop smoking but haven't thought about when | 4 Participants | 13 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) White | 33 Participants | 64 Participants | 97 Participants |
| Rurality Highly Rural | 1 Participants | 0 Participants | 1 Participants |
| Rurality Missing | 0 Participants | 0 Participants | 0 Participants |
| Rurality Rural | 18 Participants | 37 Participants | 55 Participants |
| Rurality Urban | 22 Participants | 46 Participants | 68 Participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 21 Participants |
| Sex: Female, Male Male | 35 Participants | 68 Participants | 103 Participants |
| Use of Texting Every Day | 33 Participants | 64 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 3 / 83 |
| other Total, other adverse events | 0 / 41 | 0 / 83 |
| serious Total, serious adverse events | 0 / 41 | 0 / 83 |
Outcome results
Participation in Tobacco Cessation Treatment
Any participation in tobacco cessation treatment (medication use, counseling)
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Participation in Tobacco Cessation Treatment | 9 Participants |
| Proactive Outreach | Participation in Tobacco Cessation Treatment | 29 Participants |
30-Day Abstinence
Number of participants who had not smoked any cigarettes in the past 30 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | 30-Day Abstinence | 2 Participants |
| Proactive Outreach | 30-Day Abstinence | 6 Participants |
7-day Abstinence
Count of participants who have not smoked in the past 7 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | 7-day Abstinence | 3 Participants |
| Proactive Outreach | 7-day Abstinence | 8 Participants |
Care Coordination
Proportion of participants who completed a care coordination call
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Care Coordination | 1 Participants |
| Proactive Outreach | Care Coordination | 11 Participants |
Cut Down in Heaviness of Smoking
Cut down by 10 cigarettes per day or in frequency of smoking from daily to some days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Cut Down in Heaviness of Smoking | 9 Participants |
| Proactive Outreach | Cut Down in Heaviness of Smoking | 25 Participants |
Medications Used
count of participant split by tobacco treatment medications used during quit attempts
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Medications Used | Combination Nicotine Replacement | 3 Participants |
| Usual Care | Medications Used | Bupropion | 0 Participants |
| Usual Care | Medications Used | Varenicline | 1 Participants |
| Usual Care | Medications Used | did not use medication | 33 Participants |
| Usual Care | Medications Used | Single Nicotine Replacement | 4 Participants |
| Proactive Outreach | Medications Used | did not use medication | 60 Participants |
| Proactive Outreach | Medications Used | Single Nicotine Replacement | 15 Participants |
| Proactive Outreach | Medications Used | Combination Nicotine Replacement | 4 Participants |
| Proactive Outreach | Medications Used | Varenicline | 2 Participants |
| Proactive Outreach | Medications Used | Bupropion | 2 Participants |
Moved Upward on the Quit Ladder
Count of participants who indicated that they were more interested in quitting smoking than at baseline
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Moved Upward on the Quit Ladder | 13 Participants |
| Proactive Outreach | Moved Upward on the Quit Ladder | 23 Participants |
Number of Quit Attempts
Self-reported attempts to quit smoking
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Quit Attempts | 21 Participants |
| Proactive Outreach | Number of Quit Attempts | 35 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Quit or Cut Down | 12 Participants |
| Proactive Outreach | Quit or Cut Down | 32 Participants |
Types of Assistance Used
count of the types of assistance participants used
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Types of Assistance Used | Cessation Clinic or Texting/App Alone | 4 Participants |
| Usual Care | Types of Assistance Used | Medications and Cessation Clinic or Group Class | 0 Participants |
| Usual Care | Types of Assistance Used | Did not use tobacco cessation assistance | 29 Participants |
| Usual Care | Types of Assistance Used | Medications Alone | 8 Participants |
| Proactive Outreach | Types of Assistance Used | Did not use tobacco cessation assistance | 58 Participants |
| Proactive Outreach | Types of Assistance Used | Medications and Cessation Clinic or Group Class | 4 Participants |
| Proactive Outreach | Types of Assistance Used | Cessation Clinic or Texting/App Alone | 1 Participants |
| Proactive Outreach | Types of Assistance Used | Medications Alone | 20 Participants |