Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Behavioral: CEASE Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Control<br>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. | |
| Experimental: Intervention<br>The Intervention Group will receive the CEASE Intervention | Behavioral: CEASE Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery of Assistance | • Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program | over 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in practice prevalence of parents who smoke | Change in practice prevalence of parents who smoke assessed at baseline and at 2 years | over 2 years | 
| Parental quit rate | Change in parental quit rate at the practice: quit in the last 2 years, cotinine-confirmed at baseline and at 2 years | over 2 years | 
| Smokefree homes and cars | • Reduced parental smoking inside homes and cars assessed by previously validated, self-reported strictly enforced rules prohibiting smoking in the home and car | over 2 years | 
| Parental use of pharmacotherapy or services | Use of services from any smoking cessation program and/or pharmacotherapy to help quit smoking | over 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco control, tobacco treatment, pediatrics, parents