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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt-in clinical reminder | Experimental | 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 |
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| Opt-out tobacco treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staff training and academic detailing | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E. Sherman, MD MPH | VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Steven S. Fu, MD MSCE | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010-5011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35276337 | Derived | 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. |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
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This outcome will be based on VA administrative data
| 2-year intervention period |
| D015438 |
| Health Behavior |