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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00664261
First received: April 19, 2008
Last updated: December 17, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Tobacco Use Disorder
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 Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Addressing Parental Smoking by Changing Pediatric Office Systems

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit [ Designated as safety issue: No ]
  • Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of clinician asking about parental smoking as assessed by parent surveys at baseline and 12 months after clinic visit [ Designated as safety issue: No ]
  • Rates of clinician advising parents to quit as assessed by parent surveys at baseline and 12 months after clinic visit [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Percentage of parental smokers who have 7-day abstinence at both 3 and 12 months after clinic visit [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: September 2007
Study Completion Date: July 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664261

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Chair: Jonathan Winickoff, MD, MPH Massachusetts General Hospital
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00664261     History of Changes
Other Study ID Numbers: CDR0000584270, MGH-200P002323
Study First Received: April 19, 2008
Last Updated: December 17, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
tobacco use disorder

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

ClinicalTrials.gov processed this record on October 19, 2014