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Electronic Proactive Outreach for Smokers With COPD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04462289
Enrollment
124
Registered
2020-07-08
Start date
2020-09-01
Completion date
2024-09-30
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive, Smoking

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

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Patient-level randomized pilot

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Participation in Tobacco Cessation Treatment6 monthsAny participation in tobacco cessation treatment (medication use, counseling)

Secondary

MeasureTime frameDescription
Quit or Cut Down6 monthsNumber of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency
7-day Abstinence6 monthsCount of participants who have not smoked in the past 7 days
Moved Upward on the Quit Ladder6 monthsCount of participants who indicated that they were more interested in quitting smoking than at baseline
Cut Down in Heaviness of Smoking6 monthsCut down by 10 cigarettes per day or in frequency of smoking from daily to some days
30-Day Abstinence6 monthsNumber of participants who had not smoked any cigarettes in the past 30 days
Number of Quit Attempts6 monthsSelf-reported attempts to quit smoking
Types of Assistance Used6 monthscount of the types of assistance participants used
Medications Used6 monthscount of participant split by tobacco treatment medications used during quit attempts
Care Coordination60 daysProportion 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

ArmCount
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
Total124

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath03
Overall StudyLost to Follow-up45
Overall StudyWithdrawal by Subject13

Baseline characteristics

CharacteristicUsual CareProactive OutreachTotal
Age, Continuous67.5 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 Participants26 Participants42 Participants
Cigarettes per Day
11 to 20
20 Participants47 Participants67 Participants
Cigarettes per Day
21 or more
5 Participants10 Participants15 Participants
Education Attainment
College Graduate/Post-Graduate
5 Participants19 Participants24 Participants
Education Attainment
High School Granduate/GED
15 Participants23 Participants38 Participants
Education Attainment
Less than High School
2 Participants3 Participants5 Participants
Education Attainment
Some College or Vocational Education
19 Participants38 Participants57 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants75 Participants114 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants8 Participants10 Participants
Heaviness of Smoking Index2.41 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 Quit20 Participants54 Participants74 Participants
Past Year Quit Attempts27 Participants36 Participants63 Participants
Quit Ladder
I don't want to stop/I should stop smoking but don't really want to
14 Participants25 Participants39 Participants
Quit Ladder
I really want to stop smoking and intend to in the next 1 or 3 months
15 Participants17 Participants32 Participants
Quit Ladder
I really want to stop smoking, but I don't know when I will
6 Participants16 Participants22 Participants
Quit Ladder
I want to stop smoking and hope to soon
2 Participants12 Participants14 Participants
Quit Ladder
I want to stop smoking but haven't thought about when
4 Participants13 Participants17 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants8 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants8 Participants9 Participants
Race (NIH/OMB)
White
33 Participants64 Participants97 Participants
Rurality
Highly Rural
1 Participants0 Participants1 Participants
Rurality
Missing
0 Participants0 Participants0 Participants
Rurality
Rural
18 Participants37 Participants55 Participants
Rurality
Urban
22 Participants46 Participants68 Participants
Sex: Female, Male
Female
6 Participants15 Participants21 Participants
Sex: Female, Male
Male
35 Participants68 Participants103 Participants
Use of Texting Every Day33 Participants64 Participants97 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 413 / 83
other
Total, other adverse events
0 / 410 / 83
serious
Total, serious adverse events
0 / 410 / 83

Outcome results

Primary

Participation in Tobacco Cessation Treatment

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareParticipation in Tobacco Cessation Treatment9 Participants
Proactive OutreachParticipation in Tobacco Cessation Treatment29 Participants
Secondary

30-Day Abstinence

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual Care30-Day Abstinence2 Participants
Proactive Outreach30-Day Abstinence6 Participants
Secondary

7-day Abstinence

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual Care7-day Abstinence3 Participants
Proactive Outreach7-day Abstinence8 Participants
Secondary

Care Coordination

Proportion of participants who completed a care coordination call

Time frame: 60 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareCare Coordination1 Participants
Proactive OutreachCare Coordination11 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareCut Down in Heaviness of Smoking9 Participants
Proactive OutreachCut Down in Heaviness of Smoking25 Participants
Secondary

Medications Used

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

Time frame: 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareMedications UsedCombination Nicotine Replacement3 Participants
Usual CareMedications UsedBupropion0 Participants
Usual CareMedications UsedVarenicline1 Participants
Usual CareMedications Useddid not use medication33 Participants
Usual CareMedications UsedSingle Nicotine Replacement4 Participants
Proactive OutreachMedications Useddid not use medication60 Participants
Proactive OutreachMedications UsedSingle Nicotine Replacement15 Participants
Proactive OutreachMedications UsedCombination Nicotine Replacement4 Participants
Proactive OutreachMedications UsedVarenicline2 Participants
Proactive OutreachMedications UsedBupropion2 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareMoved Upward on the Quit Ladder13 Participants
Proactive OutreachMoved Upward on the Quit Ladder23 Participants
Secondary

Number of Quit Attempts

Self-reported attempts to quit smoking

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Quit Attempts21 Participants
Proactive OutreachNumber of Quit Attempts35 Participants
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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareQuit or Cut Down12 Participants
Proactive OutreachQuit or Cut Down32 Participants
Secondary

Types of Assistance Used

count of the types of assistance participants used

Time frame: 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareTypes of Assistance UsedCessation Clinic or Texting/App Alone4 Participants
Usual CareTypes of Assistance UsedMedications and Cessation Clinic or Group Class0 Participants
Usual CareTypes of Assistance UsedDid not use tobacco cessation assistance29 Participants
Usual CareTypes of Assistance UsedMedications Alone8 Participants
Proactive OutreachTypes of Assistance UsedDid not use tobacco cessation assistance58 Participants
Proactive OutreachTypes of Assistance UsedMedications and Cessation Clinic or Group Class4 Participants
Proactive OutreachTypes of Assistance UsedCessation Clinic or Texting/App Alone1 Participants
Proactive OutreachTypes of Assistance UsedMedications Alone20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026