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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03044691
Recruitment Status : Terminated (confounding factors impacted the ability to fully complete the aims of this study)
First Posted : February 7, 2017
Results First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: ResearchACTS software Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : November 11, 2017

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.

Primary Outcome Measures :
  1. Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 11-17 years old

Exclusion Criteria:

  • 18 years and older

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03044691

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United States, Florida
University of Florida Clinics
Gainesville, Florida, United States, 32610
UF Health Family Medicine and Pediatrics-Blanding
Jacksonville, Florida, United States, 32244
UF Health Family Medicine and Pediatrics-Baymeadows
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
University of Florida
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Principal Investigator: Elizabeth Shenkman, PhD University of Florida
Principal Investigator: Ramzi Salloum, PhD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:

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Responsible Party: University of Florida Identifier: NCT03044691    
Other Study ID Numbers: IRB201600151
4KB16 ( Other Grant/Funding Number: Florida Department of Health )
OCR15156 ( Other Identifier: Universiy of Florida )
First Posted: February 7, 2017    Key Record Dates
Results First Posted: July 1, 2019
Last Update Posted: July 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action