๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-03

Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics (NCT03477435)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: VA Office of Research and Development

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: VA NY Harbor Healthcare System, New York, NY โ€” New York, New York

๐Ÿงช Interventions in This Study

  • Staff training and academic detailing (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • VA NY Harbor Healthcare System, New York, NY โ€” New York, New York

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Tobacco Use clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—