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

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).

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: ResearchACTS software

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Clinics
    • Jacksonville, Florida, United States, 32244
      • UF Health Family Medicine and Pediatrics-Blanding
    • Jacksonville, Florida, United States, 32256
      • UF Health Family Medicine and Pediatrics-Baymeadows

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 11-17 years old

Exclusion Criteria:

• 18 years and older

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Elizabeth Shenkman, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): November 11, 2017
• Study Completion (Actual): November 11, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB201600151; 4KB16 (Other Grant/Funding Number: Florida Department of Health); OCR15156 (Other Identifier: Universiy of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No