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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA127127 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| American Academy of Pediatrics | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Control | No Intervention | 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 | The Intervention Group will receive the CEASE Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEASE Intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan P Winickoff, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35603037 | Derived | 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. | |
| 34306227 | Derived | 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. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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 |
| 34306222 | Derived | 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. |
| 31403675 | Derived | 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. |
| 31157864 | Derived | 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. |
| 30981026 | Derived | 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. |
| 30858346 | Derived | 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. |
| 30521040 | Derived | 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. |