Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics (NCT03477435) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
United States1,365 participantsStarted 2019-08-28
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of smokers who accept referral to treatment (Quitline or text messaging)
Timeframe: 2-year intervention period
2
Proportion of smokers who engage in treatment with the Quitline or text messaging service
Timeframe: 2-year intervention period
3
Abstinence at the end of the 2-year intervention period