Tobacco DependenceNCT01882348
Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
A study testing CEASE Intervention in people with Tobacco Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- CEASE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,888 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2015to 26 Oct 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice.
- "Smoker" will be defined as answering "yes" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?"
- "Former smoker" will be defined as answering "no" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "Have you quit smoking in the last 2 years?"
Who cannot join
- Parents under age 18
- Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
- Non-consenting individuals
- Non-English speakers
- Prior enrollment in the study during a previous healthcare visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke.
Read the detailed description
The CEASE intervention works within existing systems of care to address parental smoking. Based on national guidelines and extensive qualitative research obtained in pilot testing, elements of CEASE can be tailored to work with particular practices' staffing, resources, and physical configuration. CEASE integrates evidence-based tobacco-use screening, cessation assistance, and referral to outside services into visits with families in pediatric clinics. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit.(3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment via faxed enrollment form; and (5) Review of CEASE action sheets at each visit until the family is smoke-free. We train practices in the adoption, implementation, and maintenance of the intervention. A more detailed training manual discusses additional in-depth strategies for maximizing billing and reimbursement, materials for seasonal cessation opportunities and supporting employees' own cessation efforts.
- Conditions
- Tobacco Dependence
- Being tested
- CEASE Intervention
- Keywords
- tobacco control, tobacco treatment, pediatrics, parents
- 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.
CEASE InterventionBehavioural
The CEASE intervention works within existing systems of care to address parental smoking. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit. (3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment; and (5) Review of CEASE action sheets at each visit until the family is smoke-free.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control | No intervention | Control groups will receive equal number of contacts for training in preparation for enrollment and data collection for the study. Clinicians will be given the option to receive a standard American Academy of Pediatrics tobacco control pamphlet to distribute. Control groups have the option to receive access to the CEASE online module intervention at the conclusion of the research study which allows practitioners in this group to receive 26 continuing education credit hours. |
| Intervention | Experimental | The Intervention Group will receive the CEASE Intervention Receives: Behavioral: CEASE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of Assistance
- Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program
Measured: over 2 years
Secondary outcomes (4)
Change in practice prevalence of parents who smoke
Change in practice prevalence of parents who smoke assessed at baseline and at 2 years
Measured: over 2 years
Parental quit rate
Change in parental quit rate at the practice: quit in the last 2 years, cotinine-confirmed at baseline and at 2 years
Measured: over 2 years
Smokefree homes and cars
- Reduced parental smoking inside homes and cars assessed by previously validated, self-reported strictly enforced rules prohibiting smoking in the home and car
Measured: over 2 years
Parental use of pharmacotherapy or services
Use of services from any smoking cessation program and/or pharmacotherapy to help quit smoking
Measured: over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study start14 Apr 2015
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
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 DependenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), American Academy of Pediatrics
- Responsible party
- Principal investigator, Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital
- Investigators
- Jonathan P Winickoff, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882348
- Sponsor's protocol ID
- 2013P000777/MGH
- Other IDs
- R01CA127127
- Status last verified
- Apr 2019
- First submitted
- 18 Jun 2013
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Nabi-Burza E, Winickoff JP, Drehmer JE, Zeegers MP, Walters BH. A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. J Smok Cessat. 2022 May 5;2022:4156982. doi: 10.1155/2022/4156982. eCollection 2022.
PubMed 35603037Nabi-Burza E, Drehmer JE, Walters BH, Willemsen MC, Zeegers MPA, Winickoff JP. Smoking Cessation Treatment for Parents Who Dual Use E-Cigarettes and Traditional Cigarettes. J Smok Cessat. 2021 Mar 17;2021:6639731. doi: 10.1155/2021/6639731. eCollection 2021.
PubMed 34306227Nabi-Burza E, Wasserman R, Drehmer JE, Walters BH, Luo M, Ossip D, Winickoff JP. Spontaneous Smoking Cessation in Parents. J Smok Cessat. 2021 May 17;2021:5526715. doi: 10.1155/2021/5526715. eCollection 2021.
PubMed 34306222Nabi-Burza E, Drehmer JE, Hipple Walters B, Rigotti NA, Ossip DJ, Levy DE, Klein JD, Regan S, Gorzkowski JA, Winickoff JP. Treating Parents for Tobacco Use in the Pediatric Setting: The Clinical Effort Against Secondhand Smoke Exposure Cluster Randomized Clinical Trial. JAMA Pediatr. 2019 Oct 1;173(10):931-939. doi: 10.1001/jamapediatrics.2019.2639.
PubMed 31403675Nabi-Burza E, Winickoff JP, Drehmer JE, Gorzkowski JA, Klein JD, Levy DE, Ossip DJ, Regan S, Rigotti NA, Hipple Walters B. Innovations in parental smoking cessation assistance delivered in the child healthcare setting. Transl Behav Med. 2020 Oct 8;10(4):1039-1052. doi: 10.1093/tbm/ibz070.
PubMed 31157864Nabi-Burza E, Regan S, Walters BH, Drehmer JE, Rigotti NA, Ossip DJ, Gorzkowski JA, Levy DE, Winickoff JP. Parental Dual Use of e-Cigarettes and Traditional Cigarettes. Acad Pediatr. 2019 Sep-Oct;19(7):842-848. doi: 10.1016/j.acap.2019.04.001. Epub 2019 Apr 11.
PubMed 30981026Drehmer JE, Nabi-Burza E, Hipple Walters B, Ossip DJ, Levy DE, Rigotti NA, Klein JD, Winickoff JP. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019 Apr;143(4):e20183249. doi: 10.1542/peds.2018-3249. Epub 2019 Mar 11.
PubMed 30858346Drehmer JE, Ossip DJ, Nabi-Burza E, Hipple Walters B, Gorzkowski JA, Winickoff JP. Pediatric Office Delivery of Smoking Cessation Assistance for Breast-Feeding Mothers. Nicotine Tob Res. 2020 Mar 16;22(3):346-353. doi: 10.1093/ntr/nty247.
PubMed 30521040
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Pediatric Office Systems Nationally to Address Parental Tobacco Use
- ClinicalTrials.gov ID
- NCT01882348
- Acronym / sponsor ID
- 2013P000777/MGH
- Conditions
- Tobacco Dependence
- Keywords
- tobacco control, tobacco treatment, pediatrics, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,888 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), American Academy of Pediatrics
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 20 Jun 2013 (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.
The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke.
Detailed description
The CEASE intervention works within existing systems of care to address parental smoking. Based on national guidelines and extensive qualitative research obtained in pilot testing, elements of CEASE can be tailored to work with particular practices' staffing, resources, and physical configuration. CEASE integrates evidence-based tobacco-use screening, cessation assistance, and referral to outside services into visits with families in pediatric clinics. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit.(3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment via faxed enrollment form; and (5) Review of CEASE action sheets at each visit until the family is smoke-free. We train practices in the adoption, implementation, and maintenance of the intervention. A more detailed training manual discusses additional in-depth strategies for maximizing billing and reimbursement, materials for seasonal cessation opportunities and supporting employees' own cessation efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | No intervention | –Control groups will receive equal number of contacts for training in preparation for enrollment and data collection for the study. Clinicians will be given the option to receive a standard American Academy of Pediatrics tobacco control pamphlet to distribute. Control groups have the option to receive access to the CEASE online module intervention at the conclusion of the research study which allows practitioners in this group to receive 26 continuing education credit hours. |
| Intervention | Experimental | Behavioral: CEASE InterventionThe Intervention Group will receive the CEASE Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice.
- "Smoker" will be defined as answering "yes" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?"
- "Former smoker" will be defined as answering "no" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "Have you quit smoking in the last 2 years?"
Key exclusion criteria (5 listed)
- Parents under age 18
- Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
- Non-consenting individuals
- Non-English speakers
- Prior enrollment in the study during a previous healthcare visit.
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 |
|---|---|---|
| CEASE InterventionThe CEASE intervention works within existing systems of care to address parental smoking. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit. (3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment; and (5) Review of CEASE action sheets at each visit until the family is smoke-free. | Behavioural | Intervention |
Primary outcome
Delivery of Assistance
Time frame: over 2 years
• Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program
4 secondary outcomes
Change in practice prevalence of parents who smoke
Time frame: over 2 years
Parental quit rate
Time frame: over 2 years
Smokefree homes and cars
Time frame: over 2 years
Parental use of pharmacotherapy or services
Time frame: over 2 years
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 9 Apr 2019.
- Derived from this study: PubMed 35603037Nabi-Burza E, Winickoff JP, Drehmer JE, Zeegers MP, Walters BH. A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. J Smok Cessat. 2022 May 5;2022:4156982. doi: 10.1155/2022/4156982. eCollection 2022.
- Derived from this study: PubMed 34306227Nabi-Burza E, Drehmer JE, Walters BH, Willemsen MC, Zeegers MPA, Winickoff JP. Smoking Cessation Treatment for Parents Who Dual Use E-Cigarettes and Traditional Cigarettes. J Smok Cessat. 2021 Mar 17;2021:6639731. doi: 10.1155/2021/6639731. eCollection 2021.
- Derived from this study: PubMed 34306222Nabi-Burza E, Wasserman R, Drehmer JE, Walters BH, Luo M, Ossip D, Winickoff JP. Spontaneous Smoking Cessation in Parents. J Smok Cessat. 2021 May 17;2021:5526715. doi: 10.1155/2021/5526715. eCollection 2021.
- Derived from this study: PubMed 31403675Nabi-Burza E, Drehmer JE, Hipple Walters B, Rigotti NA, Ossip DJ, Levy DE, Klein JD, Regan S, Gorzkowski JA, Winickoff JP. Treating Parents for Tobacco Use in the Pediatric Setting: The Clinical Effort Against Secondhand Smoke Exposure Cluster Randomized Clinical Trial. JAMA Pediatr. 2019 Oct 1;173(10):931-939. doi: 10.1001/jamapediatrics.2019.2639.
- Derived from this study: PubMed 31157864Nabi-Burza E, Winickoff JP, Drehmer JE, Gorzkowski JA, Klein JD, Levy DE, Ossip DJ, Regan S, Rigotti NA, Hipple Walters B. Innovations in parental smoking cessation assistance delivered in the child healthcare setting. Transl Behav Med. 2020 Oct 8;10(4):1039-1052. doi: 10.1093/tbm/ibz070.
- Derived from this study: PubMed 30981026Nabi-Burza E, Regan S, Walters BH, Drehmer JE, Rigotti NA, Ossip DJ, Gorzkowski JA, Levy DE, Winickoff JP. Parental Dual Use of e-Cigarettes and Traditional Cigarettes. Acad Pediatr. 2019 Sep-Oct;19(7):842-848. doi: 10.1016/j.acap.2019.04.001. Epub 2019 Apr 11.
- Derived from this study: PubMed 30858346Drehmer JE, Nabi-Burza E, Hipple Walters B, Ossip DJ, Levy DE, Rigotti NA, Klein JD, Winickoff JP. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019 Apr;143(4):e20183249. doi: 10.1542/peds.2018-3249. Epub 2019 Mar 11.
- Derived from this study: PubMed 30521040Drehmer JE, Ossip DJ, Nabi-Burza E, Hipple Walters B, Gorzkowski JA, Winickoff JP. Pediatric Office Delivery of Smoking Cessation Assistance for Breast-Feeding Mothers. Nicotine Tob Res. 2020 Mar 16;22(3):346-353. doi: 10.1093/ntr/nty247.
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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 P Winickoff, MD, MPH principal investigator
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 CEASE Intervention in people with Tobacco Dependence, 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.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. 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?
Delivery of Assistance (time frame: over 2 years). 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 NCT01882348, 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 9 Apr 2019.