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=5 Participants	68.9 years STANDARD_DEVIATION 7.22 • n=7 Participants	68.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	68 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	75 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	64 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Rurality Highly Rural	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Rurality Rural	18 Participants n=5 Participants	37 Participants n=7 Participants	55 Participants n=5 Participants
Rurality Urban	22 Participants n=5 Participants	46 Participants n=7 Participants	68 Participants n=5 Participants
Rurality Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Education Attainment Less than High School	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Education Attainment High School Granduate/GED	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Education Attainment Some College or Vocational Education	19 Participants n=5 Participants	38 Participants n=7 Participants	57 Participants n=5 Participants
Education Attainment College Graduate/Post-Graduate	5 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants
Cigarettes per Day 10 or fewer	16 Participants n=5 Participants	26 Participants n=7 Participants	42 Participants n=5 Participants
Cigarettes per Day 11 to 20	20 Participants n=5 Participants	47 Participants n=7 Participants	67 Participants n=5 Participants
Cigarettes per Day 21 or more	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Past Year Quit Attempts	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
No particular timeframe to Quit	20 Participants n=5 Participants	54 Participants n=7 Participants	74 Participants n=5 Participants
Heaviness of Smoking Index	2.41 units on a scale STANDARD_DEVIATION 1.61 • n=5 Participants	2.48 units on a scale STANDARD_DEVIATION 1.42 • n=7 Participants	2.46 units on a scale STANDARD_DEVIATION 1.48 • n=5 Participants
Quit Ladder I don't want to stop/I should stop smoking but don't really want to	14 Participants n=5 Participants	25 Participants n=7 Participants	39 Participants n=5 Participants
Quit Ladder I want to stop smoking but haven't thought about when	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Quit Ladder I really want to stop smoking, but I don't know when I will	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Quit Ladder I want to stop smoking and hope to soon	2 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants
Quit Ladder I really want to stop smoking and intend to in the next 1 or 3 months	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Use of Texting Every Day	33 Participants n=5 Participants	64 Participants n=7 Participants	97 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Any 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 months

Number 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 months

Number 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 months

Count 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 months

Count 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 months

Cut 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 days

Proportion 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 months

Self-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 months

count 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 months

count 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 Bupropion	0 Participants	2 Participants
Medications Used did not use medication	33 Participants	60 Participants
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

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

Dr. Anne Melzer

Minneapolis VA Health Care System

Phone: 6124674413

Email: anne.melzer2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place