eCEASE to Support Treatment for Parental Tobacco Use (eCEASE)

Electronic Pediatric Office Systems 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation; Tobacco Smoking; Second Hand Tobacco Smoke
• Intervention / Treatment: Behavioral: iEHR + Navigator

• Study Type: Interventional
• Enrollment (Actual): 817
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 02568
      • The Children'S Hospital Of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iEHR + Navigator	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.
No Intervention: Usual Care Control; Usual care delivery in pediatric primary care offices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): October 10, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Tobacco cessation; Family tobacco screening
• Other Study ID Numbers: 2021P001892; 1R01CA245145-01 (U.S. NIH Grant/Contract); 20-018146 (Other Identifier: The Children's Hospital of Philadelphia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After the associated research findings have been published.
• IPD Sharing Access Criteria: Email to the principal investigators at CHOP and Massachusetts General Hospital (MGH).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No