eCEASE to Support Treatment for Parental Tobacco Use

NCT04974736 | Completed Results

• 3 other identifiers: 2021P0018921R01CA245145-0120-018146
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking; Second Hand Tobacco Smoke; Smoking Cessation

Keywords

Family tobacco screening; Tobacco cessation

Outcome Measures

Primary Outcomes (1)

• Parental Combusted Tobacco Quit Rate at 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

  12-months

Secondary Outcomes (5)

• Rates of Parental Quit Attempts

  12-months

• Rates of Parental Use of Pharmacotherapy or Services

  12-months

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

  12-months

• Incremental Cost Per Quit of the Intervention

  12-months

• Rates of Tobacco Use Treatment Delivery

  36 months

Study Arms (2)

iEHR + Navigator

EXPERIMENTAL

Behavioral: iEHR + Navigator

Usual Care Control

NO INTERVENTION

Usual care delivery in pediatric primary care offices.

Interventions

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.

iEHR + Navigator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 02568, United States

Location

Related Publications (1)

• 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.

  PMID: 40864466 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Smoking Cessation; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Results Point of Contact

• Title: Jonathan P. WInickoff
• Organization: Massachusetts General Hospital

jwinickoff@mgh.harvard.edu

(617) 726-2728

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-arm Randomized Control Trial with a stratified cluster randomization

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 23, 2021
• Study Start: July 16, 2021
• Primary Completion: October 10, 2023
• Study Completion: August 15, 2024
• Last Updated: April 15, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the associated research findings have been published.
• Access Criteria: Email to the principal investigators at CHOP and Massachusetts General Hospital (MGH).

Locations

US (1)