Smoking CessationNCT03044691
The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care
A study testing ResearchACTS software in people with Smoking Cessation, run by University of Florida at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- ResearchACTS software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2017to 11 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 11-17 years old
Who cannot join
- 18 years and older
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida Clinics
Gainesville, Florida, 32610
UF Health Family Medicine and Pediatrics-Blanding
Jacksonville, Florida, 32244
UF Health Family Medicine and Pediatrics-Baymeadows
Jacksonville, Florida, 32256
About this study
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).
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- ResearchACTS software
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResearchACTS softwareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ResearchACTS software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start27 Feb 2017
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
Why it stopped: confounding factors impacted the ability to fully complete the aims of this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shenkman, PhD, Principal investigator, University of FloridaRamzi Salloum, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044691
- Sponsor's protocol ID
- IRB201600151
- Other IDs
- 4KB16, OCR15156
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2017
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT03044691
- Acronym / sponsor ID
- IRB201600151
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: confounding factors impacted the ability to fully complete the aims of this study
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: ResearchACTS softwareParticipants 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 11-17 years old
Key exclusion criteria (1 listed)
- 18 years and older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResearchACTS softwarescreen 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. | Behavioural | Intervention Clinic |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Shenkman, PhD principal investigator
University of Florida
Ramzi Salloum, PhD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ResearchACTS software in people with Smoking Cessation, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.