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

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Tobacco Use

Treatments: Behavioral: Staff training and academic detailing

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03477435

IIR 17-056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,365 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,365 participants in 2 patient groups

Opt-in clinical reminder

Experimental group

Description:

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

Treatment:

Behavioral: Staff training and academic detailing

Opt-out tobacco treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Staff training and academic detailing