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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Staff training and academic detailing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010-5011
      • VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opt-in clinical reminder; 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; 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.
Experimental: Opt-out tobacco treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the two approaches (opt-out vs opt-in)	This outcome will be based on cost data at the end of the intervention	2-year intervention period
Use of smoking cessation medications	This outcome will be based on VA administrative data	2-year intervention period

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Steven S. Fu, MD MSCE, Minneapolis VA Health Care System, Minneapolis, MN; Principal Investigator: Scott E. Sherman, MD MPH, VA NY Harbor Healthcare System, New York, NY

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; tobacco dependence; quitline
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Use Disorder; Smoking; Smoking Cessation; Tobacco Use
• Other Study ID Numbers: IIR 17-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No