Tobacco Use DisorderNCT00664261
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
A study testing smoking cessation intervention, cancer prevention and counseling intervention in people with Tobacco Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- smoking cessation intervention, cancer prevention and counseling intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Addressing Parental Smoking by Changing Pediatric Office Systems
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- smoking cessation intervention, cancer prevention, counseling intervention, educational intervention, laboratory biomarker analysis
- Keywords
- tobacco use disorder
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
cancer preventionOther
counseling interventionOther
educational interventionOther
laboratory biomarker analysisOther
questionnaire administrationOther
survey administrationOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (10)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jonathan Winickoff, MD, MPH, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664261
- Sponsor's protocol ID
- CDR0000584270
- Other IDs
- MGH-200P002323
- Status last verified
- Jun 2011
- First submitted
- 19 Apr 2008
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Drehmer JE, Hipple B, Ossip DJ, Nabi-Burza E, Winickoff JP. A Cross-Sectional Study of Happiness and Smoking Cessation among Parents. J Smok Cessat. 2017 Mar;12(1):6-14. doi: 10.1017/jsc.2015.6. Epub 2015 Mar 24.
PubMed 28163788Drehmer JE, Hipple B, Nabi-Burza E, Ossip DJ, Chang Y, Rigotti NA, Winickoff JP. Proactive enrollment of parents to tobacco quitlines in pediatric practices is associated with greater quitline use: a cross-sectional study. BMC Public Health. 2016 Jun 24;16:520. doi: 10.1186/s12889-016-3147-1.
PubMed 27342141Winickoff JP, Nabi-Burza E, Chang Y, Regan S, Drehmer J, Finch S, Wasserman R, Ossip D, Hipple B, Woo H, Klein J, Rigotti NA. Sustainability of a parental tobacco control intervention in pediatric practice. Pediatrics. 2014 Nov;134(5):933-41. doi: 10.1542/peds.2014-0639. Epub 2014 Oct 20.
PubMed 25332492Mahabee-Gittens EM, Collins BN, Murphy S, Woo H, Chang Y, Dempsey J, Weiley V, Winickoff JP. The parent-child dyad and risk perceptions among parents who quit smoking. Am J Prev Med. 2014 Nov;47(5):596-603. doi: 10.1016/j.amepre.2014.07.010. Epub 2014 Sep 4.
PubMed 25201508Drehmer JE, Ossip DJ, Nabi-Burza E, Rigotti NA, Hipple B, Woo H, Chang Y, Winickoff JP. Thirdhand smoke beliefs of parents. Pediatrics. 2014 Apr;133(4):e850-6. doi: 10.1542/peds.2013-3392. Epub 2014 Mar 3.
PubMed 24590745Winickoff JP, Nabi-Burza E, Chang Y, Finch S, Regan S, Wasserman R, Ossip D, Woo H, Klein J, Dempsey J, Drehmer J, Hipple B, Weiley V, Murphy S, Rigotti NA. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics. 2013 Jul;132(1):109-17. doi: 10.1542/peds.2012-3901.
PubMed 23796741Friebely J, Rigotti NA, Chang Y, Hall N, Weiley V, Dempsey J, Hipple B, Nabi-Burza E, Murphy S, Woo H, Winickoff JP. Parent smoker role conflict and planning to quit smoking: a cross-sectional study. BMC Public Health. 2013 Feb 22;13:164. doi: 10.1186/1471-2458-13-164.
PubMed 23433098Drehmer JE, Ossip DJ, Rigotti NA, Nabi-Burza E, Woo H, Wasserman RC, Chang Y, Winickoff JP. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med. 2012 Nov;43(5):533-6. doi: 10.1016/j.amepre.2012.07.020.
PubMed 23079177
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Parental Smoking by Changing Pediatric Office Systems
- ClinicalTrials.gov ID
- NCT00664261
- Acronym / sponsor ID
- CDR0000584270
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessation intervention | Behavioural | – |
| cancer prevention | Other | – |
| counseling intervention | Other | – |
| educational intervention | Other | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| survey administration | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 28163788Drehmer JE, Hipple B, Ossip DJ, Nabi-Burza E, Winickoff JP. A Cross-Sectional Study of Happiness and Smoking Cessation among Parents. J Smok Cessat. 2017 Mar;12(1):6-14. doi: 10.1017/jsc.2015.6. Epub 2015 Mar 24.
- Derived from this study: PubMed 27342141Drehmer JE, Hipple B, Nabi-Burza E, Ossip DJ, Chang Y, Rigotti NA, Winickoff JP. Proactive enrollment of parents to tobacco quitlines in pediatric practices is associated with greater quitline use: a cross-sectional study. BMC Public Health. 2016 Jun 24;16:520. doi: 10.1186/s12889-016-3147-1.
- Derived from this study: PubMed 25332492Winickoff JP, Nabi-Burza E, Chang Y, Regan S, Drehmer J, Finch S, Wasserman R, Ossip D, Hipple B, Woo H, Klein J, Rigotti NA. Sustainability of a parental tobacco control intervention in pediatric practice. Pediatrics. 2014 Nov;134(5):933-41. doi: 10.1542/peds.2014-0639. Epub 2014 Oct 20.
- Derived from this study: PubMed 25201508Mahabee-Gittens EM, Collins BN, Murphy S, Woo H, Chang Y, Dempsey J, Weiley V, Winickoff JP. The parent-child dyad and risk perceptions among parents who quit smoking. Am J Prev Med. 2014 Nov;47(5):596-603. doi: 10.1016/j.amepre.2014.07.010. Epub 2014 Sep 4.
- Derived from this study: PubMed 24590745Drehmer JE, Ossip DJ, Nabi-Burza E, Rigotti NA, Hipple B, Woo H, Chang Y, Winickoff JP. Thirdhand smoke beliefs of parents. Pediatrics. 2014 Apr;133(4):e850-6. doi: 10.1542/peds.2013-3392. Epub 2014 Mar 3.
- Derived from this study: PubMed 23796741Winickoff JP, Nabi-Burza E, Chang Y, Finch S, Regan S, Wasserman R, Ossip D, Woo H, Klein J, Dempsey J, Drehmer J, Hipple B, Weiley V, Murphy S, Rigotti NA. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics. 2013 Jul;132(1):109-17. doi: 10.1542/peds.2012-3901.
- Derived from this study: PubMed 23433098Friebely J, Rigotti NA, Chang Y, Hall N, Weiley V, Dempsey J, Hipple B, Nabi-Burza E, Murphy S, Woo H, Winickoff JP. Parent smoker role conflict and planning to quit smoking: a cross-sectional study. BMC Public Health. 2013 Feb 22;13:164. doi: 10.1186/1471-2458-13-164.
- Derived from this study: PubMed 23079177Drehmer JE, Ossip DJ, Rigotti NA, Nabi-Burza E, Woo H, Wasserman RC, Chang Y, Winickoff JP. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med. 2012 Nov;43(5):533-6. doi: 10.1016/j.amepre.2012.07.020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Winickoff, MD, MPH study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation intervention, cancer prevention and counseling intervention in people with Tobacco Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664261, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.