Referral Approaches for Tobacco Use

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Scott E. Sherman, MD MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steven S. Fu, MD MSCE

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Scott E. Sherman, MD MPH

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

This trial is for current smokers who have been seen by a nursing assistant on the PACT team at the Manhattan or Brooklyn VA campus within the last year. It's also open to those nurses and administrative staff who smoke. Non-English speakers cannot participate.

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

Patient Post-Visit Survey Population - Had a visit with an NA/RN included in the study AND Current smoker

Nursing Assistants/Registered Nurses - Work on a PACT at the Manhattan or Brooklyn VA campus

Exclusion Criteria

Nursing Assistants/Registered Nurses - None

Survey Cohort - Non-English speaking

Administrative Cohort - None

Treatment Details

Interventions

• Staff training and academic detailing (Behavioral Intervention)

Trial Overview The study is comparing two methods of encouraging smoking cessation: an 'opt-out' where smokers are automatically referred to treatment unless they decline, and an 'opt-in' where smokers must actively choose to enroll in treatment programs.

Participant Groups

Group I: Opt-out tobacco treatment Experimental Treatment 1 Intervention

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.

Group II: Opt-in clinical reminder Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine