eCEASE to Support Treatment for Parental Tobacco Use

Not Applicable

Completed

• Conditions: Second Hand Tobacco Smoke; Smoking Cessation; Tobacco Smoking
• Interventions: Behavioral: iEHR + Navigator

• Registration Number: NCT04974736
• Lead Sponsor: Massachusetts General Hospital

Brief 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 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

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study Start: 2021-07-16
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Primary Completion: 2023-10-10
• Study Completion: 2024-08-15
• Results First Submitted: 2025-02-05
• Results First Submitted QC: 2025-03-05
• Results First Posted: 2025-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 817

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iEHR + Navigator	iEHR + Navigator	-

Primary Outcome Measures

Name	Time	Method
Parental Combusted Tobacco Quit Rate at 12 Months	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 Outcome Measures

Name	Time	Method
Rates of Parental Quit Attempts	12-months	Rates of parents' self-reported quit attempts between the intervention \& usual care control arms, assessed by validated surveys of parents
Rates of Parental Use of Pharmacotherapy or Services	12-months	Rates of parental use of pharmacotherapy and Quitlines between the intervention \& usual care arms, assessed by validated surveys of parents
Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars	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
Incremental Cost Per Quit of the Intervention	12-months	Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms
Rates of Tobacco Use Treatment Delivery	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

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States