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NCT Number: NCT03477435

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Tobacco Use Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA NY Harbor Healthcare System, New York, NY

New York, 10010-5011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Staff training and academic detailing

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

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

    Time frame: 2-year intervention period

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

  2. Use of smoking cessation medications

    Time frame: 2-year intervention period

    This outcome will be based on VA administrative data

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2018
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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