Tobacco SmokingeCEASENCT04974736
eCEASE to Support Treatment for Parental Tobacco Use
A study testing iEHR + Navigator in people with Tobacco Smoking and Second Hand Tobacco Smoke, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Second Hand Tobacco Smoke, Smoking Cessation
- What is being tested?
- iEHR + Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. "Smoker" will be defined as answering "yes" to either of the screening questions: "Have you smoked a cigarette, even a puff, in the past 7 days?" and "Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?"
Who cannot join
- Parent/legal guardian does not speak English;
- No telephone; and
- Prior enrollment in the study during a previous visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 02568
About this study
Official title: Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use
The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.
- Being tested
- iEHR + Navigator
- Keywords
- Family tobacco screening, Tobacco cessation
- Medical subject headings
- Tobacco Smoking, Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iEHR + NavigatorBehavioural
The iEHR + Navigator intervention consists of an iEHR part of the intervention in the pediatric primary care setting which will include routine screening of families for tobacco use and treatment delivery to parents who smoke and will be linked to the child's electronic health record.
The enrolled parents will also be offered support from Community Health Navigators, who will work with offices to provide customized cessation support to tobacco users, ensuring access to medications and services.
| Study group | Role | What they receive |
|---|---|---|
| iEHR + Navigator | Experimental | Not described Receives: Behavioral: iEHR + Navigator |
| Usual Care Control | No intervention | Usual care delivery in pediatric primary care offices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Combusted Tobacco Quit Rate at 12 Months
Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention \& usual care arms
Measured: 12-months
Secondary outcomes (5)
Rates of Parental Quit Attempts
Rates of parents' self-reported quit attempts between the intervention \& usual care control arms, assessed by validated surveys of parents
Measured: 12-months
Rates of Parental Use of Pharmacotherapy or Services
Rates of parental use of pharmacotherapy and Quitlines between the intervention \& usual care arms, assessed by validated surveys of parents
Measured: 12-months
Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars
Rates of parental institution of smoking and vaping bans in their homes and cars between the intervention \& usual care arms, assessed by validated surveys of parents
Measured: 12-months
Incremental Cost Per Quit of the Intervention
Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms
Measured: 12-months
Rates of Tobacco Use Treatment Delivery
Assess the rates of tobacco treatment delivery (NRT prescription and quitline referrals) in the iEHR + Navigator arm vs. usual care, assessed by validated surveys of parents and EHR documentation
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start16 Jul 2021
- Primary completion10 Oct 2023
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies 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
- Parallel groups
- Model description
- 2-arm Randomized Control Trial with a stratified cluster randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974736
- Sponsor's protocol ID
- 2021P001892
- Other IDs
- 1R01CA245145-01, 20-018146
- Acronym
- eCEASE
- Status last verified
- Apr 2025
- First submitted
- 30 Jun 2021
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, after the associated research findings have been published, we will make our dataset available to investigators who email their data analysis plan to the principal investigators with the approval the Institutional Review Board (IRB) of record at Children's Hospital of Philadelphia (CHOP) and Health Information Services Group (responsible for ensuring HIPPA compliance). The data will be de-identified and validated. The dataset will include a codebook that defines the variables and describes the structure of the dataset.
Publications
Nabi-Burza E, Jenssen BP, Jeffers AM, Ramachandran J, Thayer JG, Hipple B, Levy DE, Grundmeier RW, Drouin O, Vangel M, Rigotti NA, Bryant-Stephens T, Nekrasova E, McKnight M, Winickoff JP, Fiks AG. Automated Tobacco Cessation Intervention for Parents in Pediatric Primary Care: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2529384. doi: 10.1001/jamanetworkopen.2025.29384.
PubMed 40864466
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use
- ClinicalTrials.gov ID
- NCT04974736
- Acronym / sponsor ID
- eCEASE / 2021P001892
- Keywords
- Family tobacco screening, Tobacco cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Children's Hospital of Philadelphia
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm Randomized Control Trial with a stratified cluster randomization
| Arm | Type | Receives |
|---|---|---|
| iEHR + Navigator | Experimental | Behavioral: iEHR + Navigator |
| Usual Care Control | No intervention | –Usual care delivery in pediatric primary care offices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. "Smoker" will be defined as answering "yes" to either of the screening questions: "Have you smoked a cigarette, even a puff, in the past 7 days?" and "Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?"
Key exclusion criteria (3 listed)
- Parent/legal guardian does not speak English;
- No telephone; and
- Prior enrollment in the study during a previous 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 |
|---|---|---|
| iEHR + NavigatorThe iEHR + Navigator intervention consists of an iEHR part of the intervention in the pediatric primary care setting which will include routine screening of families for tobacco use and treatment delivery to parents who smoke and will be linked to the child's electronic health record. The enrolled parents will also be offered support from Community Health Navigators, who will work with offices to provide customized cessation support to tobacco users, ensuring access to medications and services. | Behavioural | iEHR + Navigator |
Primary outcome
Parental Combusted Tobacco Quit Rate at 12 Months
Time frame: 12-months
Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention \& usual care arms
5 secondary outcomes
Rates of Parental Quit Attempts
Time frame: 12-months
Rates of Parental Use of Pharmacotherapy or Services
Time frame: 12-months
Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars
Time frame: 12-months
Incremental Cost Per Quit of the Intervention
Time frame: 12-months
Rates of Tobacco Use Treatment Delivery
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40864466Nabi-Burza E, Jenssen BP, Jeffers AM, Ramachandran J, Thayer JG, Hipple B, Levy DE, Grundmeier RW, Drouin O, Vangel M, Rigotti NA, Bryant-Stephens T, Nekrasova E, McKnight M, Winickoff JP, Fiks AG. Automated Tobacco Cessation Intervention for Parents in Pediatric Primary Care: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2529384. doi: 10.1001/jamanetworkopen.2025.29384.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, after the associated research findings have been published, we will make our dataset available to investigators who email their data analysis plan to the principal investigators with the approval the Institutional Review Board (IRB) of record at Children's Hospital of Philadelphia (CHOP) and Health Information Services Group (responsible for ensuring HIPPA compliance). The data will be de-identified and validated. The dataset will include a codebook that defines the variables and describes the structure of the dataset.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iEHR + Navigator in people with Tobacco Smoking and Second Hand Tobacco Smoke, 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 1 inclusion and 3 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 15 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parental Combusted Tobacco Quit Rate at 12 Months (time frame: 12-months). 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 NCT04974736, which also lists 1 linked publication.
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 15 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.