Clinical trial NCT01882348: Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
Official title: Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: tobacco control, tobacco treatment, pediatrics, parents
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: American Academy of Pediatrics
First posted: 2013-06-20
Enrollment: 3888
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delivery of Assistance
timeFrame: over 2 years
Secondary outcomes:
measure: Change in practice prevalence of parents who smoke
timeFrame: over 2 years
measure: Parental quit rate
timeFrame: over 2 years
measure: Smokefree homes and cars
timeFrame: over 2 years
measure: Parental use of pharmacotherapy or services
timeFrame: over 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan P Winickoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nabi-Burza E, Winickoff JP, Drehmer JE, Zeegers MP, Walters BH. A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. J Smok Cessat. 2022 May 5;2022:4156982. doi: 10.1155/2022/4156982. eCollection 2022.
citation: Nabi-Burza E, Drehmer JE, Walters BH, Willemsen MC, Zeegers MPA, Winickoff JP. Smoking Cessation Treatment for Parents Who Dual Use E-Cigarettes and Traditional Cigarettes. J Smok Cessat. 2021 Mar 17;2021:6639731. doi: 10.1155/2021/6639731. eCollection 2021.
citation: Nabi-Burza E, Wasserman R, Drehmer JE, Walters BH, Luo M, Ossip D, Winickoff JP. Spontaneous Smoking Cessation in Parents. J Smok Cessat. 2021 May 17;2021:5526715. doi: 10.1155/2021/5526715. eCollection 2021.
citation: Nabi-Burza E, Drehmer JE, Hipple Walters B, Rigotti NA, Ossip DJ, Levy DE, Klein JD, Regan S, Gorzkowski JA, Winickoff JP. Treating Parents for Tobacco Use in the Pediatric Setting: The Clinical Effort Against Secondhand Smoke Exposure Cluster Randomized Clinical Trial. JAMA Pediatr. 2019 Oct 1;173(10):931-939. doi: 10.1001/jamapediatrics.2019.2639.
citation: Nabi-Burza E, Winickoff JP, Drehmer JE, Gorzkowski JA, Klein JD, Levy DE, Ossip DJ, Regan S, Rigotti NA, Hipple Walters B. Innovations in parental smoking cessation assistance delivered in the child healthcare setting. Transl Behav Med. 2020 Oct 8;10(4):1039-1052. doi: 10.1093/tbm/ibz070.
citation: Nabi-Burza E, Regan S, Walters BH, Drehmer JE, Rigotti NA, Ossip DJ, Gorzkowski JA, Levy DE, Winickoff JP. Parental Dual Use of e-Cigarettes and Traditional Cigarettes. Acad Pediatr. 2019 Sep-Oct;19(7):842-848. doi: 10.1016/j.acap.2019.04.001. Epub 2019 Apr 11.
citation: Drehmer JE, Nabi-Burza E, Hipple Walters B, Ossip DJ, Levy DE, Rigotti NA, Klein JD, Winickoff JP. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019 Apr;143(4):e20183249. doi: 10.1542/peds.2018-3249. Epub 2019 Mar 11.
citation: Drehmer JE, Ossip DJ, Nabi-Burza E, Hipple Walters B, Gorzkowski JA, Winickoff JP. Pediatric Office Delivery of Smoking Cessation Assistance for Breast-Feeding Mothers. Nicotine Tob Res. 2020 Mar 16;22(3):346-353. doi: 10.1093/ntr/nty247.