Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Tobacco Dependence Clinical Trial

Official title:

Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882348
• Other study ID #: 2013P000777/MGH
• Secondary ID: R01CA127127
• Status: Completed
• Phase: N/A
• Start date: April 14, 2015
• Est. completion date: October 26, 2017

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3888
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• CEASE 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Academy of Pediatrics, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of Assistance	• Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program	over 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Parental use of pharmacotherapy or services	Use of services from any smoking cessation program and/or pharmacotherapy to help quit smoking	over 2 years