Smoking Cessation
Conditions
Brief summary
The primary purpose of our study is to conduct a pilot, practice-based intervention focused on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1) Anticipate (future use), (2) Ask (about tobacco use), (3) Advise (advise the patient to quit using tobacco), (4) Assess (the patient's readiness to quit using tobacco), (5) Assist (by setting a quit date, providing materials on quitting tobacco, providing tobacco cessation medications, and referring the patient for additional services and/or counseling) , and (6) Arrange (by re-contacting the patient after their quit date and arranging a follow-up visit).
Detailed description
Investigators will incorporate American Academy of Pediatrics (AAP) best practice recommendations to screen and counsel parents. The specific aims of this study are to: (1) Develop and deploy an electronic short screening tool for tobacco and nicotine product use into pediatric primary care workflow in conjunction with clinician and office staff training on the 6As and parent screening through the use of trained Clinical Practice Facilitators, clinician-engaged adaptations of the intervention to fit their practice workflow, and support for Maintenance of Certification (MOC) to engage pediatricians in implementing the best practices; (2) Gather pilot data about the effectiveness of the intervention on clinician adherence to best practices and changes in practice capacity for change, adaptive reserve, and clinician self-efficacy; and (3) Examine the congruence between documentation of the intervention in the electronic health record (EHR) and youth report of the intervention.
Interventions
BEHAVIORALResearchACTS software
screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 11-17 years old
Exclusion criteria
* 18 years and older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures | Baseline | During the recruitment period, investigators will observe feedback from patients and clinic staff on how the feasibility of using the ResearchACTS software to capture tobacco use measures in a clinical setting. Feasibility of the software tool will be demonstrated by the ability of patients to complete the assessment within the timeframe afforded during a clinical visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Clinic The control group will have to complete the Adaptive Reserve and Change Process Capability Questionnaire and Clinician Survey at baseline and 9 months. Clinicians will provide their usual care related to tobacco and nicotine product use screening and cessation recommendations. Medical record of patients will be reviewed at baseline and at 6 months. | 0 |
| Intervention Clinic Participants will be asked to complete the Youth Tobacco and Nicotine Product Questionnaire and Parent Brief Questionnaire (PBQ) using the ResearchACTS software at the point of care. A follow-up survey Youth Tobacco and Nicotine Product Primary Care survey will be administered to participants at least 30 days after their clinic visit.
ResearchACTS software: screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software. | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Total | Intervention Clinic |
|---|---|---|
| Age, Categorical <=18 years | 84 Participants | 84 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 84 participants | 84 participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants |
| Sex: Female, Male Male | 52 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 75 |
| other Total, other adverse events | 0 / 0 | 0 / 75 |
| serious Total, serious adverse events | 0 / 0 | 0 / 75 |
Outcome results
Primary
Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures
During the recruitment period, investigators will observe feedback from patients and clinic staff on how the feasibility of using the ResearchACTS software to capture tobacco use measures in a clinical setting. Feasibility of the software tool will be demonstrated by the ability of patients to complete the assessment within the timeframe afforded during a clinical visit.
Time frame: Baseline
Population: No-one was recruited into the control clinic arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Clinic | Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures | Able to complete | 0 Participants |
| Control Clinic | Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures | Unable to complete | 0 Participants |
| Intervention Clinic | Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures | Able to complete | 84 Participants |
| Intervention Clinic | Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures | Unable to complete | 0 Participants |