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The purpose of this study is to evaluate the comparative effectiveness of two different informatics-enabled implementation strategies on increasing tobacco treatment and improving smoking cessation rates for cancer control and prevention. This will be done via a two-arm pragmatic cluster randomized trial (CRT) to test the effectiveness of nudges to change (ELEVATE-S) vs. quit-focused usual care (ELEVATE) in increasing tobacco treatment (use of medication, brief advice, or referral to external counseling) and smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic health record-enabled evidence-based tobacco treatment (ELEVATE) | Active Comparator |
| |
| Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELEVATE | Behavioral | ELEVATE uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach | This will be quantified by the proportion of enrolled patients who receive tobacco use treatment (either medication or behavioral intervention (brief advice or referral to counseling)). | Up to 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient receipt of tobacco use treatment - behavioral intervention. | This will be quantified by the proportion of enrolled patients who receive tobacco use treatment behavioral intervention (brief advice or referral to counseling). | Up to 6 months post-enrollment |
| Patient receipt of tobacco use treatment - medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach | This will be quantified by the proportion of enrolled patients who receive tobacco use treatment (either medication or behavioral intervention (brief advice or referral to counseling). | Up to 12 months post-enrollment |
| Patient receipt of tobacco use treatment - behavioral intervention. |
Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Shiun Chen, M.D., MPH, ScD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Randomization occurs at the clinic level. For pragmatic concerns, the investigators expect to recruit from multiple clinics and randomization will be stratified by department to minimize the clinic effect. Clinics will be randomized on a 1:1 basis to ELEVATE-S or ELEVATE. Patients within a clinic will be assigned to the same arm.
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| ELEVATE-S | Behavioral | ELEVATE-S uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools) and implementation strategies to support patients with chronic care model-informed self-management support (patient centered flexible goals and patient-generated health data). |
|
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication. |
| Up to 6 months post-enrollment |
| Patient smoking abstinence | This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence | Up to 6 months post-enrollment |
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment behavioral intervention (brief advice or referral to counseling). |
| Up to 12 months post-enrollment |
| Patient receipt of tobacco use treatment - medication. | This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication. | Up to 12 months post-enrollment |
| Patient smoking abstinence | This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence | Up to 12 months post-enrollment |
| Patient bioverified smoking | This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence. | Up to 12 months post-enrollment |
| D001523 |
| Mental Disorders |
| D012907 | Smoking |