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Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use

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ClinicalTrials.gov Identifier: NCT01882348
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
American Academy of Pediatrics
Information provided by (Responsible Party):
Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Behavioral: CEASE Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3888 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
Actual Study Start Date : April 14, 2015
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Arm Intervention/treatment
No Intervention: Usual Care Control

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
The Intervention Group will receive the CEASE 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.




Primary Outcome Measures :
  1. Delivery of Assistance [ Time Frame: over 2 years ]
    • Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program


Secondary Outcome Measures :
  1. Change in practice prevalence of parents who smoke [ Time Frame: over 2 years ]
    Change in practice prevalence of parents who smoke assessed at baseline and at 2 years

  2. Parental quit rate [ Time Frame: over 2 years ]
    Change in parental quit rate at the practice: quit in the last 2 years, cotinine-confirmed at baseline and at 2 years

  3. Smokefree homes and cars [ Time Frame: over 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

  4. Parental use of pharmacotherapy or services [ Time Frame: over 2 years ]
    Use of services from any smoking cessation program and/or pharmacotherapy to help quit smoking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882348


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
American Academy of Pediatrics
Investigators
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Principal Investigator: Jonathan P Winickoff, MD, MPH Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan P. Winickoff, MD, MPH, Jonathan P. Winickoff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01882348     History of Changes
Other Study ID Numbers: 2013P000777/MGH
R01CA127127 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Keywords provided by Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital:
tobacco control, tobacco treatment, pediatrics, parents

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders