Nicotine Addiction, Smoking Cessation, Tobacco Smoking, Tobacco Use, Tobacco Use Cessation
Conditions
Keywords
Patient Reported Outcomes, Tobacco Treatment
Brief summary
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.
Interventions
BEHAVIORALELEVATE
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).
BEHAVIORALELEVATE-S
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).
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility Criteria: * Be receiving care at a participating clinic * Report current tobacco use (assessed by the rooming staff during the index visit) * Have a completed appointment with a participating clinic * Be an adult (at least 18 years old).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach | Up to 6 months post-enrollment | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient receipt of tobacco use treatment - behavioral intervention. | 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). |
| Patient receipt of tobacco use treatment - medication. | Up to 6 months post-enrollment | This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication. |
| Patient smoking abstinence | Up to 6 months post-enrollment | This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLi-Shiun Chen, M.D., MPH, ScD
Washington University School of Medicine
Outcome results
None listed