The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care

Not Applicable

Terminated

• Conditions: Smoking Cessation
• Interventions: Behavioral: ResearchACTS software

• Registration Number: NCT03044691
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-07
• Study Start: 2017-02-27
• Primary Completion: 2017-11-11
• Study Completion: 2017-11-11
• Results First Submitted: 2019-01-02
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Results First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 11-17 years old

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Exclusion Criteria

• 18 years and older

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Clinic	ResearchACTS software	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

UF Health Family Medicine and Pediatrics-Baymeadows; 🇺🇸 Jacksonville, Florida, United States

UF Health Family Medicine and Pediatrics-Blanding; 🇺🇸 Jacksonville, Florida, United States

University of Florida Clinics; 🇺🇸 Gainesville, Florida, United States