Clinical trial NCT04832659: Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Official title: Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Keywords: tobacco control
tobacco treatment
pediatrics
parents
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: University of Minnesota
name: American Academy of Pediatrics
name: Mississippi State University
name: University of Rochester
name: Icahn School of Medicine at Mount Sinai
name: MetroHealth System, Ohio
First posted: 2021-04-06
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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:

1. Parent/legal guardian is non-English speaking.
2. Parent/legal guardian is less than 18 years of age.

Primary outcomes:
measure: Parental quit rate
timeFrame: 12 months
Secondary outcomes:
measure: Screening for tobacco use
timeFrame: 12 months
measure: Counseling about cessation
timeFrame: 12 months
measure: Counseling about smoke-free/vape-free homes and cars
timeFrame: 12 months
measure: Nicotine replacement therapy prescriptions
timeFrame: 12 months
measure: State quitline referrals
timeFrame: 12 months
measure: Children's tobacco smoke exposure
timeFrame: 12 months
measure: Smoke-free and vape-free homes and cars
timeFrame: 12 months
measure: Identification of other household smokers
timeFrame: 12 months
measure: Smoking cessation among other household members
timeFrame: 12 months
Other outcomes:
measure: Cost per quit
timeFrame: 45 months
Locations:
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan P Winickoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: