Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
NCT ID: NCT00664261
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
3000 participants
INTERVENTIONAL
2007-09-30
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared with standard care in helping parents stop smoking.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To compare the effectiveness of the Clinical Effort Against Secondhand Smoke (CEASE) intervention vs no intervention in increasing clinicians' delivery of evidence-based parental smoking cessation assistance in pediatric healthcare settings.
* To compare the effectiveness of this intervention vs no intervention on parental smoking behaviors.
* To test the level of systematic practice implementation of the intervention using existing validated measures in an Implementation Process Survey (IPS).
* To evaluate, in an exploratory fashion, additional key implementation step measures mapped from the five A's (Ask, Advise, Assess, Assist, Arrange) to see how well they predict tobacco control service delivery in pediatric healthcare settings.
* To use process results from the IPS (i.e., previously validated and exploratory measures) to improve the adoption, implementation, and maintenance of the intervention in this study.
OUTLINE: This is a multicenter study. Participants are stratified according to practice. Participants are randomized to 1 of 2 intervention arms.
* Arm I (Clinical Effort Against Secondhand Smoke \[CEASE\] intervention): The CEASE intervention incorporates a number of materials into the operations of the pediatric practice, including baseline questionnaires that screen for parental tobacco use and readiness to quit smoking, enroll in quitline counseling, or explore pharmacotherapy; a label that affixes to the child's problem list in the medical record, documenting parental smoking status and indicating the patient's secondhand exposure, thus encouraging continuity of cessation support in cross-coverage situations; and decision support for clinicians that prompts delivery of exposure-reduction counseling and distribution of motivational-messaging handouts (i.e., halflets) to parents for education, skills training, and psychosocial support. Parental messaging elements include strategies or methods for quitting, collaborative goal setting, identifying personal barriers to quitting, and focused strategies for reducing secondhand-smoke exposure of the patient. Additional intervention materials include a HIPAA-compliant form for enrolling the smoker in counseling through the telephone quitline; pre-printed, practice-embossed prescription pads for prescribing over-the-counter nicotine-replacement therapy when desired by the smoker; pharmacotherapy posters in pediatric patient examination rooms to inform parental smokers and assist clinicians in discussing tobacco dependence treatment; and a simple implementation guide to support integrating the parent, clinician, and practice levels of the intervention.
The CEASE intervention also incorporates telephone counseling after the pediatric healthcare visit to ensure that parents receive professional, ongoing smoking-cessation counseling. Parental smokers undergo an exit interview survey and follow-up telephone surveys at 3 months and 12 months for evaluation of content of tobacco control delivered during the visit; use of messaging materials, medications, and telephone counseling sessions; current smoking status; and rules about smoking in the home and car. If the parent has had a 7-day quit at the 12-month follow-up, the parent is also asked to provide a saliva sample for cotinine analysis to confirm nonsmoking status.
* Arm II (control): Participants complete a questionnaire at baseline and an exit interview survey. They also complete telephone interviews at 3 month and 12 months. If the parent has had a 7-day quit at the 12-month follow-up, the parent is also asked to provide a saliva sample for cotinine analysis to confirm nonsmoking status.
In both arms, participating practitioners and key office staff complete Implementation Process Surveys at baseline and at 6 weeks and 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
HEALTH_SERVICES_RESEARCH
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
smoking cessation intervention
cancer prevention
counseling intervention
educational intervention
laboratory biomarker analysis
questionnaire administration
survey administration
study of high risk factors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parents or guardians meeting the following criteria:
* Self-identified as smokers on the baseline survey
* Must have a child who is seen by a pediatrician in a participating practice
* Child must not have a medically emergent condition that requires transfer outside the practice for immediate medical intervention
* Must be present at the child's healthcare visit
* Pediatric practice meeting the following criteria:
* Participates in the Pediatric Research in Office Settings (PROS) network
* Practice manager and a majority of pediatricians are willing to implement a tobacco control strategy for parental smokers
* Cares for at least 2,000 families
* Located in a geographically distinct location to minimize contamination effects of the intervention
* No practices at the same geographic location
PATIENT CHARACTERISTICS:
* Have a telephone at home (parent or guardian)
* Able to speak English (parent or guardian)
* Have a working fax machine (practice)
PRIOR CONCURRENT THERAPY:
* No prior enrollment in this study during a previous visit to the pediatric healthcare clinician (parent or guardian)
* No prior participation in phase II focus groups or other pilot tobacco control studies (practice)
* No active enrollment of patients onto other PROS trials (practice)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Winickoff, MD, MPH
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Drehmer JE, Hipple B, Ossip DJ, Nabi-Burza E, Winickoff JP. A Cross-Sectional Study of Happiness and Smoking Cessation among Parents. J Smok Cessat. 2017 Mar;12(1):6-14. doi: 10.1017/jsc.2015.6. Epub 2015 Mar 24.
Drehmer JE, Hipple B, Nabi-Burza E, Ossip DJ, Chang Y, Rigotti NA, Winickoff JP. Proactive enrollment of parents to tobacco quitlines in pediatric practices is associated with greater quitline use: a cross-sectional study. BMC Public Health. 2016 Jun 24;16:520. doi: 10.1186/s12889-016-3147-1.
Winickoff JP, Nabi-Burza E, Chang Y, Regan S, Drehmer J, Finch S, Wasserman R, Ossip D, Hipple B, Woo H, Klein J, Rigotti NA. Sustainability of a parental tobacco control intervention in pediatric practice. Pediatrics. 2014 Nov;134(5):933-41. doi: 10.1542/peds.2014-0639. Epub 2014 Oct 20.
Mahabee-Gittens EM, Collins BN, Murphy S, Woo H, Chang Y, Dempsey J, Weiley V, Winickoff JP. The parent-child dyad and risk perceptions among parents who quit smoking. Am J Prev Med. 2014 Nov;47(5):596-603. doi: 10.1016/j.amepre.2014.07.010. Epub 2014 Sep 4.
Drehmer JE, Ossip DJ, Nabi-Burza E, Rigotti NA, Hipple B, Woo H, Chang Y, Winickoff JP. Thirdhand smoke beliefs of parents. Pediatrics. 2014 Apr;133(4):e850-6. doi: 10.1542/peds.2013-3392. Epub 2014 Mar 3.
Winickoff JP, Nabi-Burza E, Chang Y, Finch S, Regan S, Wasserman R, Ossip D, Woo H, Klein J, Dempsey J, Drehmer J, Hipple B, Weiley V, Murphy S, Rigotti NA. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics. 2013 Jul;132(1):109-17. doi: 10.1542/peds.2012-3901.
Friebely J, Rigotti NA, Chang Y, Hall N, Weiley V, Dempsey J, Hipple B, Nabi-Burza E, Murphy S, Woo H, Winickoff JP. Parent smoker role conflict and planning to quit smoking: a cross-sectional study. BMC Public Health. 2013 Feb 22;13:164. doi: 10.1186/1471-2458-13-164.
Drehmer JE, Ossip DJ, Rigotti NA, Nabi-Burza E, Woo H, Wasserman RC, Chang Y, Winickoff JP. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med. 2012 Nov;43(5):533-6. doi: 10.1016/j.amepre.2012.07.020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MGH-200P002323
Identifier Type: -
Identifier Source: secondary_id
CDR0000584270
Identifier Type: -
Identifier Source: org_study_id