eCEASE to Support Treatment for Parental Tobacco Use

NCT ID: NCT04974736

Last Updated: 2025-04-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

817 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2024-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Smoking Second Hand Tobacco Smoke Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm Randomized Control Trial with a stratified cluster randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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iEHR + Navigator

Group Type EXPERIMENTAL

iEHR + Navigator

Intervention Type 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.

Usual Care Control

Usual care delivery in pediatric primary care offices.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

1. Parent/legal guardian does not speak English;
2. No telephone; and
3. Prior enrollment in the study during a previous visit.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan P. Winickoff, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40864466 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R01CA245145-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-018146

Identifier Type: OTHER

Identifier Source: secondary_id

2021P001892

Identifier Type: -

Identifier Source: org_study_id

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