Trial Outcomes & Findings for The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care (NCT NCT03044691)
NCT ID: NCT03044691
Last Updated: 2019-07-01
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Baseline
Results posted on
2019-07-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
84
|
|
Overall Study
COMPLETED
|
0
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
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.
|
Intervention Clinic
n=84 Participants
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.
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.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
84 Participants
n=84 Participants
|
84 Participants
n=84 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
|
Sex: Female, Male
Female
|
—
|
32 Participants
n=84 Participants
|
32 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
—
|
52 Participants
n=84 Participants
|
52 Participants
n=84 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
84 participants
n=84 Participants
|
84 participants
n=84 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No-one was recruited into the control clinic arm.
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.
Outcome measures
| Measure |
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.
|
Intervention Clinic
n=84 Participants
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.
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.
|
|---|---|---|
|
Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures
Able to complete
|
0 Participants
|
84 Participants
|
|
Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures
Unable to complete
|
0 Participants
|
0 Participants
|
Adverse Events
Control Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place