Tobacco Use
Conditions
Keywords
smoking, tobacco dependence, quitline, smoking cessation
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.
Interventions
BEHAVIORALStaff 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of smokers who accept referral to treatment (Quitline or text messaging) | 2-year intervention period | 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. |
| Proportion of smokers who engage in treatment with the Quitline or text messaging service | 2-year intervention period | This outcome will be based on data from the Quitline and SmokefreeTXT. |
| Abstinence at the end of the 2-year intervention period | 7-day abstinence | Abstinence will be based on self-report, as is recommended for population-level studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of the two approaches (opt-out vs opt-in) | 2-year intervention period | This outcome will be based on cost data at the end of the intervention |
| Use of smoking cessation medications | 2-year intervention period | This outcome will be based on VA administrative data |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott E. Sherman, MD MPH
VA NY Harbor Healthcare System, New York, NY
PRINCIPAL_INVESTIGATORSteven S. Fu, MD MSCE
Minneapolis VA Health Care System, Minneapolis, MN
Outcome results
None listed