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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA245145-01 | U.S. NIH Grant/Contract | View source | |
| 20-018146 | Other Identifier | The Children's Hospital of Philadelphia |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Children's Hospital of Philadelphia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iEHR + Navigator | Experimental |
| |
| Usual Care Control | No Intervention | Usual care delivery in pediatric primary care offices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iEHR + Navigator | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12-months |
| Rates of Parental Use of Pharmacotherapy or Services |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 02568 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40864466 | Derived | 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. |
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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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After the associated research findings have been published.
Email to the principal investigators at CHOP and Massachusetts General Hospital (MGH).
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A two-arm parallel cluster randomized trial was conducted in 12 pediatric practices at Children's Hospital of Philadelphia. Practices were eligible if ≥10% of child patients had Medicaid and ≥40 daily visits. Eligible practices were paired based on size and estimated smoking rate, with six pairs selected to ensure sufficient size and representativeness. Within each pair, practices were randomly assigned to either the intervention or control group using computer-generated allocation.
Cluster randomized controlled trial, conducted from July 2021 to August 2023 in Twelve Philadelphia region pediatric primary care practices within the Children's Hospital of Philadephia network. Parents who used combusted tobacco in the past seven days and attended a child's preventive healthcare visit were enrolled in the study.
| ID | Title | Description |
|---|---|---|
| FG000 | eCEASE (iEHR + Navigator) | Parents in intervention practices were proactively offered eCEASE (automated delivery of Nicotine Replacement Therapy (NRT), enrollment in the quitline and SmokefreeTXT, and cessation support from a health navigator). |
| FG001 | Usual Care Control | Usual care delivery in pediatric primary care offices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | eCEASE (iEHR + Navigator) | iEHR + Navigator: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12-months |
|
15 months: Each participants adverse events were collected from the time they signed the consent to enroll in the study till they completed their follow-up data collection survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eCEASE (iEHR + Navigator) | iEHR + Navigator: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan P. WInickoff | Massachusetts General Hospital | (617) 726-2728 | jwinickoff@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2025 | Apr 7, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2020 | Mar 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 | Health Behavior |
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2-arm Randomized Control Trial with a stratified cluster randomization
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After the intervention has been assigned at random to one practice in each of the six pairs, the intervention will be blinded at random with either the label "A" or the label "B", and the other label will be assigned to the control practice. The statisticians will be blinded as to which of "A" and "B" is the intervention until the analyses are completed.
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Rates of parental use of pharmacotherapy and Quitlines between the intervention & usual care arms, assessed by validated surveys of parents
| 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 | 12-months |
| Incremental Cost Per Quit of the Intervention | Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms | 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 | 36 months |
| BG001 | Usual Care Control | Usual care delivery in pediatric primary care offices. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | One participant chose to not share their sex. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Parents were enrolled at 12 pediatric practices in eastern Pennsylvania. | Number | participants |
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| Usual Care Control |
Usual care delivery in pediatric primary care offices. |
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| Secondary | 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 | Those parents who completed the follow-up survey and reported smoking a tobacco product in the last 7 days were used in the denominator. | Posted | Count of Participants | Participants | 12-months |
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| Secondary | 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 | Participants who completed the 12 month follow up | Posted | Count of Participants | Participants | 12-months |
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| Secondary | 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 | Participants who completed follow-up | Posted | Count of Participants | Participants | 12-months |
|
|
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| Secondary | Incremental Cost Per Quit of the Intervention | Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms | Not Posted | 12-months | Participants |
| Secondary | 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 | Not Posted | 36 months | Participants |
| 0 |
| 408 |
| 0 |
| 408 |
| 0 |
| 408 |
| EG001 | Usual Care Control | Usual care delivery in pediatric primary care offices. | 0 | 409 | 0 | 409 | 0 | 409 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Enrolled in SmokefreeTXT |
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