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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03044691
• Other study ID #: IRB201600151
• Secondary ID: 4KB16OCR15156
• Status: Terminated
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: November 11, 2017

Study information

• Verified date: April 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: November 11, 2017
• Est. primary completion date: November 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• 11-17 years old

Exclusion Criteria:

• 18 years and older

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida Clinics	Gainesville	Florida
United States	UF Health Family Medicine and Pediatrics-Baymeadows	Jacksonville	Florida
United States	UF Health Family Medicine and Pediatrics-Blanding	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline