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

NCT03477435 | Active Not Recruiting

• 1 other identifier: IIR 17-056
• Study Type: interventional
• Target: 1,365
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use

Keywords

smoking; tobacco dependence; quitline; smoking cessation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  7-day abstinence

Secondary Outcomes (2)

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

  2-year intervention period

• Use of smoking cessation medications

  2-year intervention period

Study Arms (2)

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

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.

Behavioral: Staff training and academic detailing

Interventions

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.

Opt-in clinical reminder; Opt-out tobacco treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

Related Publications (1)

• 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.

  PMID: 35276337 DERIVED

MeSH Terms

Conditions

Tobacco Use; Smoking; Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Study Officials

• Scott E. Sherman, MD MPH

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

• Steven S. Fu, MD MSCE

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: August 28, 2019
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)