Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Sponsor

Lead Sponsor: Massachusetts General Hospital

Collaboratore: 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

Fonte Massachusetts General Hospital
Breve riassunto

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.

Descrizione dettagliata

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.

Stato generale Not yet recruiting
Data d'inizio 2021-06-01
Data di completamento 2025-02-01
Data di completamento principale 2025-02-01
Fase N/A
Tipo di studio Interventional
Il risultato principale
Misurare Lasso di tempo
Parental quit rate 12 months
Esito secondario
Misurare Lasso di tempo
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
Iscrizione 868
Condizione
Intervento

Tipo di intervento: Behavioral

Nome intervento: CEASE

Descrizione: 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 di intervento: Behavioral

Nome intervento: CEASE + BIO

Descrizione: 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.

Etichetta del gruppo del braccio: CEASE + BIO

Eleggibilità

Criteri:

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.

Genere: All

Età minima: 18 Years

Età massima: N/A

Volontari sani: Accepts Healthy Volunteers

Ufficiale generale
Cognome Ruolo Affiliazione
Jonathan P Winickoff, MD, MPH Principal Investigator Massachusetts General Hospital
Contatto generale

Cognome: Jeremy E Drehmer, MPH

Telefono: 617-726-3419

E-mail: [email protected]

Posizione
Servizio, struttura: Massachusetts General Hospital
Paesi di posizione

United States

Data di verifica

2021-04-01

Parte responsabile

Genere: Principal Investigator

Affiliazione dello sperimentatore: Massachusetts General Hospital

Nome completo dello sperimentatore: Jonathan P. Winickoff, MD, MPH

Titolo dello sperimentatore: Professor

parole
Ha accesso esteso No
Condizione Sfoglia
Numero di armi 2
Braccio di gruppo

Etichetta: CEASE

Genere: Active Comparator

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

Etichetta: CEASE + BIO

Genere: Experimental

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

Acronimo ABC Quit
Dati del paziente Yes
Informazioni sul design dello studio

Assegnazione: Randomized

Modello di intervento: Parallel Assignment

Scopo principale: Treatment

Mascheramento: None (Open Label)

Fonte: ClinicalTrials.gov

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