Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Patrocinadores

Patrocinador principal: Massachusetts General Hospital

Colaborador: National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Minnesota
American Academy of Pediatrics
Mississippi State University
University of Rochester
Icahn School of Medicine at Mount Sinai

Fuente Massachusetts General Hospital
Resumen breve

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.

Descripción detallada

This trial will examine the effectiveness of systematic cotinine testing of children seen at pediatric practices using blood already collected at the 1-year well child visit. 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 child's 1-year well child visit. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents at the 2-year well child visit to assess parental quit rate and children's tobacco smoke exposure.

Estado general Not yet recruiting
Fecha de inicio 2021-06-01
Fecha de Terminación 2025-02-01
Fecha de finalización primaria 2025-02-01
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Parental quit rate 12 months
Resultado secundario
Medida Periodo de tiempo
Screening for tobacco use 12 months
Counseling about cessation 12 months
Counseling about smoke-free/vape-free homes and cars 12 months
Nicotine replacement therapy prescriptions 12 months
State quitline referrals 12 months
Children's tobacco smoke exposure 12 months
Smoke-free and vape-free homes and cars 12 months
Identification of other household smokers 12 months
Smoking cessation among other household members 12 months
Inscripción 868
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: CEASE

Descripción: 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 for a 12-month well-child visit 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.

Tipo de intervención: Behavioral

Nombre de intervención: CEASE + BIO

Descripción: Children randomized to the CEASE + BIO group will have dried blood spots collected for cotinine measurement at the 12-month well-child visit. 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.

Etiqueta de grupo de brazo: CEASE + BIO

Elegibilidad

Criterios:

Inclusion Criteria: 1. Child presenting for 12-month well-child visit. 2. Child blood draw planned for lead and/or hemoglobin screening. 3. Parent/legal guardian of the child. 4. Parent/legal guardian is a current smoker (past 7 days). Exclusion Criteria: 1. Parent/legal guardian does not have a phone. 2. Parent/legal guardian is non-English speaking. 3. Parent/legal guardian is less than 18 years of age. 4. Parent/legal guardian has plans to move away from the pediatric practice in the next year.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Jonathan P Winickoff, MD, MPH Principal Investigator Massachusetts General Hospital
Contacto general

Apellido: Jeremy E Drehmer, MPH

Teléfono: 617-726-3419

Email: [email protected]

Ubicación
Instalaciones: Massachusetts General Hospital
Ubicacion Paises

United States

Fecha de verificación

2021-04-01

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Massachusetts General Hospital

Nombre completo del investigador: Jonathan P. Winickoff, MD, MPH

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: CEASE

Tipo: Active Comparator

Descripción: Those assigned to the Active Comparator arm will receive the CEASE intervention.

Etiqueta: CEASE + BIO

Tipo: Experimental

Descripción: Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO).

Acrónimo ABC Quit
Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov

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