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

NCT03044691 | Terminated Results

• 3 other identifiers: IRB2016001514KB16OCR15156
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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).

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Clinic

NO INTERVENTION

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.

Intervention Clinic

EXPERIMENTAL

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

Interventions

ResearchACTS software BEHAVIORAL

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.

Intervention Clinic

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old

You may not qualify if:

• years and older

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

University of Florida Clinics

Gainesville, Florida, 32610, United States

Location

UF Health Family Medicine and Pediatrics-Blanding

Jacksonville, Florida, 32244, United States

Location

UF Health Family Medicine and Pediatrics-Baymeadows

Jacksonville, Florida, 32256, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Assistant Professor
• Organization: Unversity of Florida

rsalloum@ufl.edu

(352) 294-4997

Study Officials

• Elizabeth Shenkman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ramzi Salloum, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: February 27, 2017
• Primary Completion: November 11, 2017
• Study Completion: November 11, 2017
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)