Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Mass General Brigham

Status: Completed

Conditions: Tobacco Dependence

Treatments: Behavioral: CEASE Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01882348

R01CA127127 (U.S. NIH Grant/Contract)

2013P000777/MGH

Details and patient eligibility

About

The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke.

Full description

The CEASE intervention works within existing systems of care to address parental smoking. Based on national guidelines and extensive qualitative research obtained in pilot testing, elements of CEASE can be tailored to work with particular practices' staffing, resources, and physical configuration. CEASE integrates evidence-based tobacco-use screening, cessation assistance, and referral to outside services into visits with families in pediatric clinics. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit.(3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment via faxed enrollment form; and (5) Review of CEASE action sheets at each visit until the family is smoke-free. We train practices in the adoption, implementation, and maintenance of the intervention. A more detailed training manual discusses additional in-depth strategies for maximizing billing and reimbursement, materials for seasonal cessation opportunities and supporting employees' own cessation efforts.

Enrollment: 3,888 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice.
• "Smoker" will be defined as answering "yes" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?"
• "Former smoker" will be defined as answering "no" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "Have you quit smoking in the last 2 years?"

Exclusion criteria

• Parents under age 18
• Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
• Non-consenting individuals
• Non-English speakers
• Prior enrollment in the study during a previous healthcare visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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3,888 participants in 2 patient groups

Usual Care Control

No Intervention group

Description:

Control groups will receive equal number of contacts for training in preparation for enrollment and data collection for the study. Clinicians will be given the option to receive a standard American Academy of Pediatrics tobacco control pamphlet to distribute. Control groups have the option to receive access to the CEASE online module intervention at the conclusion of the research study which allows practitioners in this group to receive 26 continuing education credit hours.

Intervention

Experimental group

Description:

The Intervention Group will receive the CEASE Intervention

Treatment:

Behavioral: CEASE Intervention