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OpenTrials
Completed

NCT Number: NCT04974736

eCEASE 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.

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Key information

Conditions

Tobacco Smoking Behavior Health Behavior Second Hand Tobacco Smoke Smoking Smoking Cessation Tobacco Use Tobacco Use Cessation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 02568, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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?"

Exclusion criteria

  • Parent/legal guardian does not speak English;
  • No telephone; and
  • Prior enrollment in the study during a previous visit.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Rates of Parental Quit Attempts

    Time frame: 12-months

    Rates of parents' self-reported quit attempts between the intervention & usual care control arms, assessed by validated surveys of parents

  2. Rates of Parental Use of Pharmacotherapy or Services

    Time frame: 12-months

    Rates of parental use of pharmacotherapy and Quitlines between the intervention & usual care arms, assessed by validated surveys of parents

  3. Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars

    Time frame: 12-months

    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

  4. Incremental Cost Per Quit of the Intervention

    Time frame: 12-months

    Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms

  5. Rates of Tobacco Use Treatment Delivery

    Time frame: 36 months

    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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Cancer Institute (NCI)

Registry information

Official study title

Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use

Acronym: eCEASE

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 23, 2021
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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