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Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking

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: NCT00664261
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 19, 2008
First Posted Date  ICMJE April 22, 2008
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit
  • Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2008)
  • Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at 1 week and 12 months after clinic visit
  • Rates of 7-day abstinence as confirmed biochemically at 3 and 12 months after clinic visit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • Rates of clinician asking about parental smoking as assessed by parent surveys at baseline and 12 months after clinic visit
  • Rates of clinician advising parents to quit as assessed by parent surveys at baseline and 12 months after clinic visit
  • Rates of clinician counseling parents about institution of rules prohibiting smoking in the home and car as assessed by parent surveys at baseline and 12 months after clinic visit
  • Percentage of parental smokers who have 7-day abstinence at both 3 and 12 months after clinic visit
  • Percentage of parental smokers reported quit attempts lasting at least 24 hours as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers using pharmacotherapy (i.e., gum, patch, lozenge, inhaler, nasal spray, or bupropion) for smoking cessation as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who received telephone counseling or other services as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who instituted home and car smoking bans, as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who expose children to second-hand smoke as assessed by parent surveys at baseline, 3 months, and 12 months after clinic visit
  • Practice implementation of tobacco control office system as assessed by process survey of clinicians and key office staff at baseline and then at 6 weeks and 6 months after completion of enrollment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2008)
  • Rates of clinician asking about parental smoking as assessed by parent surveys at 1 week and 12 months after clinic visit
  • Rates of clinician advising parents to quit as assessed by parent surveys at 1 week and 12 months after clinic visit
  • Rates of clinician counseling parents about institution of rules prohibiting smoking in the home and car as assessed by parent surveys at 1 week and 12 months after clinic visit
  • Percentage of parental smokers who have 7-day abstinence at both 3 and 12 months after clinic visit
  • Percentage of parental smokers reported quit attempts lasting at least 24 hours as assessed by parent surveys at 1 week, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers using pharmacotherapy (i.e., gum, patch, lozenge, inhaler, nasal spray, or bupropion) for smoking cessation as assessed by parent surveys at 1 week, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who received telephone counseling or other services as assessed by parent surveys at 1 week, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who instituted home and car smoking bans, as assessed by parent surveys at 1 week, 3 months, and 12 months after clinic visit
  • Percentage of parental smokers who expose children to second-hand smoke as assessed by parent surveys at 1 week, 3 months, and 12 months after clinic visit
  • Practice implementation of tobacco control office system as assessed by process survey of clinicians and key office staff at baseline and then at 6 weeks and 6 months after completion of enrollment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
Official Title  ICMJE Addressing Parental Smoking by Changing Pediatric Office Systems
Brief Summary

RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective than standard care in increasing the number of parents who stop smoking.

PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared with standard care in helping parents stop smoking.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Behavioral: smoking cessation intervention
  • Other: cancer prevention
  • Other: counseling intervention
  • Other: educational intervention
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Other: survey administration
  • Procedure: study of high risk factors
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 19, 2008)
3000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664261
Other Study ID Numbers  ICMJE CDR0000584270
MGH-200P002323
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jonathan Winickoff, MD, MPH Massachusetts General Hospital
PRS Account National Cancer Institute (NCI)
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP