eCEASE to Support Treatment for Parental Tobacco Use

Smoking Cessation Clinical Trial

— eCEASE  

Official title:

Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974736
• Other study ID #: 2021P001892
• Secondary ID: 1R01CA245145-012
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 817
• Est. completion date: December 31, 2024
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Second Hand Tobacco Smoke
• Smoking Cessation
• Tobacco Smoking

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Children's Hospital of Philadelphia, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental combusted tobacco quit rate at 12 months	Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, cotinine confirmed at 12 months between the iEHR + Navigator & usual care arms	12-months
Secondary	Rates of parental quit attempts	Rates of parents' self-reported quit attempts between the iEHR + Navigator & usual care arms, assessed by validated surveys of parents	12-months
Secondary	Rates of parental use of pharmacotherapy or services	Rates of parental use of pharmacotherapy and Quitlines between the iEHR + Navigator & usual care arms, assessed by validated surveys of parents	12-months
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 iEHR + Navigator & usual care arms, assessed by validated surveys of parents	12-months
Secondary	Incremental cost per quit of the intervention	Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms	12-months
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	36 months