Tobacco UseNCT03477435
Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
A study testing Staff training and academic detailing in people with Tobacco Use, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Staff training and academic detailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,365 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Survey Cohort -- Non-English speaking
- Nursing Assistants/Registered Nurses -- None
- Administrative Cohort -- None
- Patient Post-Visit Survey Population -- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
About this study
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.
- Conditions
- Tobacco Use
- Being tested
- Staff training and academic detailing
- Keywords
- smoking, tobacco dependence, quitline, smoking cessation
- Medical subject headings
- Tobacco Use, Smoking, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staff training and academic detailingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Opt-in clinical reminder | Experimental | 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 Receives: Behavioral: Staff training and academic detailing |
| Opt-out tobacco treatment | Experimental | 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. Receives: Behavioral: Staff training and academic detailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-year intervention period
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.
Measured: 2-year intervention period
Abstinence at the end of the 2-year intervention period
Abstinence will be based on self-report, as is recommended for population-level studies
Measured: 7-day abstinence
Secondary outcomes (2)
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
Measured: 2-year intervention period
Use of smoking cessation medications
This outcome will be based on VA administrative data
Measured: 2-year intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start28 Aug 2019
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies 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
- Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
- Masking
- None (open label)
- Enrolment
- 1,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott E. Sherman, MD MPH, Principal investigator, VA NY Harbor Healthcare System, New York, NYSteven S. Fu, MD MSCE, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477435
- Sponsor's protocol ID
- IIR 17-056
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2018
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
- ClinicalTrials.gov ID
- NCT03477435
- Acronym / sponsor ID
- IIR 17-056
- Conditions
- Tobacco Use
- Keywords
- smoking, tobacco dependence, quitline, smoking cessation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,365 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
| Arm | Type | Receives |
|---|---|---|
| Opt-in clinical reminder | Experimental | Behavioral: Staff training and academic detailingAs 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 |
| Opt-out tobacco treatment | Experimental | Behavioral: Staff training and academic detailingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Survey Cohort -- Non-English speaking
- Nursing Assistants/Registered Nurses -- None
- Administrative Cohort -- None
- Patient Post-Visit Survey Population -- Non-English speaking
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 |
|---|---|---|
| Staff training and academic detailingBoth 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. | Behavioural | Opt-in clinical reminder, Opt-out tobacco treatment |
Primary outcome
Proportion of smokers who accept referral to treatment (Quitline or text messaging)
Time frame: 2-year intervention period
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.
Proportion of smokers who engage in treatment with the Quitline or text messaging service
Time frame: 2-year intervention period
This outcome will be based on data from the Quitline and SmokefreeTXT.
Abstinence at the end of the 2-year intervention period
Time frame: 7-day abstinence
Abstinence will be based on self-report, as is recommended for population-level studies
2 secondary outcomes
Cost-effectiveness of the two approaches (opt-out vs opt-in)
Time frame: 2-year intervention period
Use of smoking cessation medications
Time frame: 2-year intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 35276337Haber 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.
- 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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staff training and academic detailing in people with Tobacco Use, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of smokers who accept referral to treatment (Quitline or text messaging) (time frame: 2-year intervention period). The study lists 3 primary outcomes in all. 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 NCT03477435, which also lists 1 linked publication.
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 6 Apr 2026.