Clinical trial NCT03477435: Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
Official title: Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use
Keywords: smoking
tobacco dependence
quitline
smoking cessation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-03-26
Enrollment: 1365
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of smokers who accept referral to treatment (Quitline or text messaging)
timeFrame: 2-year intervention period
measure: Proportion of smokers who engage in treatment with the Quitline or text messaging service
timeFrame: 2-year intervention period
measure: Abstinence at the end of the 2-year intervention period
timeFrame: 7-day abstinence
Secondary outcomes:
measure: Cost-effectiveness of the two approaches (opt-out vs opt-in)
timeFrame: 2-year intervention period
measure: Use of smoking cessation medications
timeFrame: 2-year intervention period
Other outcomes:
Locations:
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Scott E. Sherman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Steven S. Fu, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.