Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT00664261
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2008-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Addressing Parental Smoking by Changing Pediatric Office Systems
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MGH-200P002323 | None | None | View |