ClinicalTrials.gg
Active, not recruitingNCT03477435Updated Apr 6, 2026

Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics

An interventional study of Staff training and academic detailing in Tobacco Use, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
1,365
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.

Enrollment
26th of 286
1,365 · median 120
Started
2019
with 27 others
No phase
231 of 311
38 open now
Primary completion
2027-04
later than 26 of 62 live
Registered
109th of 311
by date

Among the 311 studies in Tobacco Use with a site in United States, this one is the 26th largest by enrollment of the 286 interventional ones that give a count, is one of 28 that started in 2019, is one of 231 with no phase, reaches primary completion later than 26 of the 62 other live ones, and was the 109th registered.

Tobacco Use

421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.

Browse Tobacco Use studies →

Open to participants now

52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

Read the detailed description

This project is a Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of specific evidence-based approaches for behavioral tobacco dependence treatment, Quitlines and text messaging, at the Manhattan and Brooklyn campuses of the VA New York Harbor Healthcare System (NYHHS). The project will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. Researchers will randomly assign clinical care teams at each VA campus to either an opt-out or an opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

03

Conditions studied

  • Tobacco Use

Keywords

  • smoking
  • tobacco dependence
  • quitline
  • smoking cessation
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Survey Cohort -- Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker
  • Nursing Assistants/Registered Nurses -- Work on a PACT at the Manhattan or Brooklyn VA campus
  • Administrative Cohort -- Have been seen by a PACT team at the Manhattan or Brooklyn VA campus AND Current smoker
  • Patient Post-Visit Survey Population -- Had a visit with an NA/RN included in the study AND Current smoker

Exclusion criteria

Exclusion Criteria:

  • Survey Cohort -- Non-English speaking
  • Nursing Assistants/Registered Nurses -- None
  • Administrative Cohort -- None
  • Patient Post-Visit Survey Population -- Non-English speaking
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,365 participants (actual)

Study arms

  • Experimental
    Opt-in clinical reminder

    As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout

    Behavioral: Staff training and academic detailing

  • Experimental
    Opt-out tobacco treatment

    The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.

    Behavioral: Staff training and academic detailing

Interventions

  • BehavioralStaff training and academic detailing

    Both arms will receive training at baseline to help their patients quit smoking. The training will be a mix of content and process education. We will provide brief updates to staff every 6 months throughout the intervention period, which will focus primarily on process education. We will monitor which staff attend and reach out separately to staff who did not. During the month after implementation of the clinical reminders, two study investigators will make a brief outreach visit to each staff member. We will follow a script, using the seven steps recommended by the National Resource Center for Academic Detailing: 1) Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The key message (Step 3) will include demonstration of the clinical reminder, review of the evidence for telephone counseling and text messaging and how to refer patients.

06

What researchers measure

Primary outcomes

  1. Proportion of smokers who accept referral to treatment (Quitline or text messaging)

    This outcome will be based on intervention process data. Note that we will measure both offering and accepting referral, but our outcome will be accepting referral.

    Time frame: 2-year intervention period

  2. Proportion of smokers who engage in treatment with the Quitline or text messaging service

    This outcome will be based on data from the Quitline and SmokefreeTXT.

    Time frame: 2-year intervention period

  3. Abstinence at the end of the 2-year intervention period

    Abstinence will be based on self-report, as is recommended for population-level studies

    Time frame: 7-day abstinence

Secondary outcomes

  1. Cost-effectiveness of the two approaches (opt-out vs opt-in)

    This outcome will be based on cost data at the end of the intervention

    Time frame: 2-year intervention period

  2. Use of smoking cessation medications

    This outcome will be based on VA administrative data

    Time frame: 2-year intervention period

07

Study locations

1 site
08

References and documents

Publications

  • Haber Y, Fu SS, Rogers E, Richter K, Tenner C, Dognin J, Goldfeld K, Gold HT, Sherman SE. A novel opt-in vs opt-out approach to referral-based treatment of tobacco use in Veterans Affairs (VA) primary care clinics: A provider-level randomized controlled trial protocol. Contemp Clin Trials. 2022 May;116:106716. doi: 10.1016/j.cct.2022.106716. Epub 2022 Mar 8. PubMed 35276337 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2019 (actual). Primary completion is estimated for Apr 2027, 91 months after the start.

Of 167 non-industry interventional studies with no phase under Tobacco Use, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 91 months is above that.

Counting every sponsor, half of 223 studies reached it within 16 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 26, 2018
StartActual
Aug 28, 2019
Primary completionEst.
Apr 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Apr 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477435
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Aug 28, 2019
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Scott E. Sherman, MD MPH
principal investigator · VA NY Harbor Healthcare System, New York, NY
Steven S. Fu, MD MSCE
principal investigator · Minneapolis VA Health Care System, Minneapolis, MN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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