Pulmonary Disease, Chronic ObstructiveNCT04462289

Electronic Proactive Outreach for Smokers With COPD

A study testing Proactive Outreach in people with Pulmonary Disease, Chronic Obstructive and Smoking, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive, Smoking
What is being tested?: Proactive Outreach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 30 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Already enrolled in behavioral VA tobacco treatment
Enrolled in hospice
Undergoing active cancer treatment
Advanced dementia
Unable to communicate in English

Trial locations and contacts

1 site in 1 country.

United States1 site

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Pulmonary Disease, Chronic Obstructive, Smoking
Being tested: Proactive Outreach
Keywords: smoking cessation, Pulmonary Disease, Chronic Obstructive, implementation science
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proactive OutreachBehavioural
Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs

Study groups in NCT04462289
Study group	Role	What they receive
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. Receives: Behavioral: Proactive Outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

Participation in Tobacco Cessation Treatment
Any participation in tobacco cessation treatment (medication use, counseling)
Measured: 6 months

Secondary outcomes (9)

30-Day Abstinence
Number of participants who had not smoked any cigarettes in the past 30 days
Measured: 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
Measured: 6 months
7-day Abstinence
Count of participants who have not smoked in the past 7 days
Measured: 6 months
Moved Upward on the Quit Ladder
Count of participants who indicated that they were more interested in quitting smoking than at baseline
Measured: 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
Measured: 6 months
Care Coordination
Proportion of participants who completed a care coordination call
Measured: 60 days
Number of Quit Attempts
Self-reported attempts to quit smoking
Measured: 6 months
Types of Assistance Used
count of the types of assistance participants used
Measured: 6 months
Medications Used
count of participant split by tobacco treatment medications used during quit attempts
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202030 Sep 2024

First posted8 Jul 2020
Study start1 Sep 2020
Primary completion31 Jul 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patient-level randomized pilot
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04462289
Sponsor's protocol ID: CDX 20-001
Status last verified: Aug 2025
First submitted: 2 Jul 2020
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)
ClinicalTrials.gov ID: NCT04462289
Acronym / sponsor ID: CDX 20-001
Conditions: Pulmonary Disease, Chronic Obstructive, Smoking
Keywords: smoking cessation, Pulmonary Disease, Chronic Obstructive, implementation science
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Sep 2020 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 8 Jul 2020 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Patient-level randomized pilot

Arm	Type	Receives
Usual Care	No intervention	–Randomly assigned sample who will receive usual care for tobacco cessation treatment
Proactive Outreach	Experimental	Behavioral: Proactive OutreachRandomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

Already enrolled in behavioral VA tobacco treatment
Enrolled in hospice
Undergoing active cancer treatment
Advanced dementia
Unable to communicate in English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proactive OutreachMotivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs	Behavioural	Proactive Outreach

Primary outcome

Participation in Tobacco Cessation Treatment
Time frame: 6 months
Any participation in tobacco cessation treatment (medication use, counseling)

9 secondary outcomes

30-Day Abstinence
Time frame: 6 months
Quit or Cut Down
Time frame: 6 months
7-day Abstinence
Time frame: 6 months
Moved Upward on the Quit Ladder
Time frame: 6 months
Cut Down in Heaviness of Smoking
Time frame: 6 months
Care Coordination
Time frame: 60 days
Number of Quit Attempts
Time frame: 6 months
Types of Assistance Used
Time frame: 6 months
Medications Used
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	41	36
Proactive Outreach	83	72

Primary outcome: Participation in Tobacco Cessation Treatment

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Usual Care n = 41	Proactive Outreach n = 83
Value	9	29

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Proactive Outreach	0 of 83 (0%)	0 of 83 (0%)	3 of 83

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne C. Melzer, MD MS principal investigator

Minneapolis VA Health Care System, Minneapolis, MN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Outreach in people with Pulmonary Disease, Chronic Obstructive and Smoking, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation in Tobacco Cessation Treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04462289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.