Trial Outcomes & Findings for Electronic Proactive Outreach for Smokers With COPD (NCT NCT04462289)
NCT ID: NCT04462289
Last Updated: 2025-08-22
Results Overview
Any participation in tobacco cessation treatment (medication use, counseling)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-22
Participant Flow
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.
Participant milestones
| Measure |
Usual Care
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
83
|
|
Overall Study
COMPLETED
|
36
|
72
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Usual Care
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Electronic Proactive Outreach for Smokers With COPD
Baseline characteristics by cohort
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.93 • n=99 Participants
|
68.9 years
STANDARD_DEVIATION 7.22 • n=107 Participants
|
68.4 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Rurality
Highly Rural
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Rurality
Rural
|
18 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Rurality
Urban
|
22 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Rurality
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Education Attainment
Less than High School
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Education Attainment
High School Granduate/GED
|
15 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Education Attainment
Some College or Vocational Education
|
19 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Education Attainment
College Graduate/Post-Graduate
|
5 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Cigarettes per Day
10 or fewer
|
16 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Cigarettes per Day
11 to 20
|
20 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Cigarettes per Day
21 or more
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Past Year Quit Attempts
|
27 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
No particular timeframe to Quit
|
20 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Heaviness of Smoking Index
|
2.41 units on a scale
STANDARD_DEVIATION 1.61 • n=99 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 1.42 • n=107 Participants
|
2.46 units on a scale
STANDARD_DEVIATION 1.48 • n=206 Participants
|
|
Quit Ladder
I don't want to stop/I should stop smoking but don't really want to
|
14 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Quit Ladder
I want to stop smoking but haven't thought about when
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Quit Ladder
I really want to stop smoking, but I don't know when I will
|
6 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Quit Ladder
I want to stop smoking and hope to soon
|
2 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Quit Ladder
I really want to stop smoking and intend to in the next 1 or 3 months
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Use of Texting Every Day
|
33 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAny participation in tobacco cessation treatment (medication use, counseling)
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Participation in Tobacco Cessation Treatment
|
9 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who had not smoked any cigarettes in the past 30 days
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
30-Day Abstinence
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who have either not smoked in the past 7 days or have cut down in heaviness or frequency
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Quit or Cut Down
|
12 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 6 monthsCount of participants who have not smoked in the past 7 days
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
7-day Abstinence
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsCount of participants who indicated that they were more interested in quitting smoking than at baseline
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Moved Upward on the Quit Ladder
|
13 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 6 monthsCut down by 10 cigarettes per day or in frequency of smoking from daily to some days
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Cut Down in Heaviness of Smoking
|
9 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 60 daysProportion of participants who completed a care coordination call
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Care Coordination
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsSelf-reported attempts to quit smoking
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Number of Quit Attempts
|
21 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 6 monthscount of the types of assistance participants used
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Types of Assistance Used
Medications Alone
|
8 Participants
|
20 Participants
|
|
Types of Assistance Used
Medications and Cessation Clinic or Group Class
|
0 Participants
|
4 Participants
|
|
Types of Assistance Used
Cessation Clinic or Texting/App Alone
|
4 Participants
|
1 Participants
|
|
Types of Assistance Used
Did not use tobacco cessation assistance
|
29 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 6 monthscount of participant split by tobacco treatment medications used during quit attempts
Outcome measures
| Measure |
Usual Care
n=41 Participants
Randomly assigned sample who will receive usual care for tobacco cessation treatment
|
Proactive Outreach
n=83 Participants
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
|
|---|---|---|
|
Medications Used
Single Nicotine Replacement
|
4 Participants
|
15 Participants
|
|
Medications Used
Combination Nicotine Replacement
|
3 Participants
|
4 Participants
|
|
Medications Used
Varenicline
|
1 Participants
|
2 Participants
|
|
Medications Used
Bupropion
|
0 Participants
|
2 Participants
|
|
Medications Used
did not use medication
|
33 Participants
|
60 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place