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

Tobacco Use Disorder Clinical Trial

Official title:

Addressing Parental Smoking by Changing Pediatric Office Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664261
• Other study ID #: CDR0000584270
• Secondary ID: MGH-200P002323
• Status: Completed
• Phase: N/A
• First received: April 19, 2008
• Last updated: December 17, 2013
• Start date: September 2007
• Est. completion date: July 2013

Study information

• Verified date: June 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• smoking cessation intervention

Other:
• cancer prevention

• counseling intervention

• educational intervention

• laboratory biomarker analysis

• questionnaire administration

• survey administration

Procedure:
• study of high risk factors

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit			No
Primary	Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit			No
Secondary	Rates of clinician asking about parental smoking as assessed by parent surveys at baseline and 12 months after clinic visit			No
Secondary	Rates of clinician advising parents to quit as assessed by parent surveys at baseline and 12 months after clinic visit			No
Secondary	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			No
Secondary	Percentage of parental smokers who have 7-day abstinence at both 3 and 12 months after clinic visit			No
Secondary	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			No
Secondary	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			No
Secondary	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			No
Secondary	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			No
Secondary	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			No
Secondary	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			No