Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Purpose
This randomized controlled trial will test whether adding biomarker measurement and informed
outreach for tobacco smoke exposure as part of routine practice increases identification and
improves treatment, effectiveness, and sustainability of a parental tobacco control
intervention that will be integrated into pediatric practice.
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
-
Yes
Inclusion Criteria
- Child 12 years old or younger presenting for a visit.
2. Child scheduled for or has had a clinically indicated blood draw at that visit
3. Parent/legal guardian of the child.
4. Parent/legal guardian is a current smoker (past 7 days).
Exclusion Criteria
- Parent/legal guardian is non-English speaking.
2. Parent/legal guardian is less than 18 years of age.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
Active Comparator CEASE
|
Those assigned to the Active Comparator arm will receive the CEASE intervention.
|
-
Behavioral: CEASE
The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.
-
Behavioral: CEASE + BIO
Children randomized to the CEASE + BIO group will have leftover blood from an already collected blood sample that was taken for a clinically indicated blood draw analyzed for cotinine. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker.
|
Experimental CEASE + BIO
|
Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).
|
-
Behavioral: CEASE
The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.
-
Behavioral: CEASE + BIO
Children randomized to the CEASE + BIO group will have leftover blood from an already collected blood sample that was taken for a clinically indicated blood draw analyzed for cotinine. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker.
|
Recruiting Locations
MetroHealth System
Cleveland,
Ohio
44109
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Study Contact
Emara Nabi, PhD
617-726-3419
enabi@mgh.harvard.edu
Detailed Description
This trial will examine the effectiveness of systematic cotinine testing of children 12 years
old or younger using blood already collected at any visit to a practice that sees pediatric
patients where there is a clinically indicated blood draw. We hypothesize that providing
cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about
their child's toxin exposure, and offering support to all household tobacco users to quit
tobacco use (Biomarker Informed Outreach (BIO)) when added to the Clinical Effort Against
Secondhand Smoke Exposure (CEASE) intervention will increase delivery of tobacco cessation
assistance, increase household cessation, reduce tobacco smoke exposure in children, and be
cost-effective. This is a 2-arm randomized controlled trial with family-level randomization
to either CEASE+BIO or CEASE arms at the time of the child's baseline visit. To compare the
effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents 12 months later
to assess parental quit rate and children's tobacco smoke exposure.