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View Clinical Trial (Medical Research Study)
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Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking - NCT00664261-02114 (Clinical Trial 216819)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy216819.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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Health Status Unknown |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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) |
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| Study is available at: |
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Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Clinical Trials Office - Massachusetts General Hospital
Phone: 877-726-5130 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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