Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01882348|
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Behavioral: CEASE Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3888 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Delivery of Assistance [ Time Frame: over 2 years ]• Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program
- 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
- 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
- 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
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jonathan P Winickoff, MD, MPH||Massachusetts General Hospital|