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Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01882348
Enrollment
3888
Registered
2013-06-20
Start date
2015-04-14
Completion date
2017-10-26
Last updated
2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

tobacco control, tobacco treatment, pediatrics, parents

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALCEASE Intervention

The CEASE intervention works within existing systems of care to address parental smoking. 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; and (5) Review of CEASE action sheets at each visit until the family is smoke-free.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
American Academy of Pediatrics
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Delivery of Assistanceover 2 years• Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program

Secondary

MeasureTime frameDescription
Change in practice prevalence of parents who smokeover 2 yearsChange in practice prevalence of parents who smoke assessed at baseline and at 2 years
Parental quit rateover 2 yearsChange in parental quit rate at the practice: quit in the last 2 years, cotinine-confirmed at baseline and at 2 years
Smokefree homes and carsover 2 years• Reduced parental smoking inside homes and cars assessed by previously validated, self-reported strictly enforced rules prohibiting smoking in the home and car
Parental use of pharmacotherapy or servicesover 2 yearsUse of services from any smoking cessation program and/or pharmacotherapy to help quit smoking

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026