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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477435
• Other study ID #: IIR 17-056
• Status: Completed
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1365
• Est. completion date: April 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Use of smoking cessation medications	This outcome will be based on VA administrative data	2-year intervention period