eCEASE Program for Smoking Cessation

(eCEASE Trial)

Overseen By Emara Nabi, MBBS, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-English speakers, No telephone, Prior enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

817 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for parents or legal guardians who smoke and are present at their child's healthcare visit. Participants must have smoked a cigarette or any other tobacco product in the past week and be able to speak English. They should not have been previously enrolled in this study and must have access to a telephone.

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

You do not have access to a phone.

Prior enrollment in the study during a previous visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iEHR + Navigator intervention to support tobacco cessation and promote smoke-free environments

12 months

Follow-up

Participants are monitored for parental tobacco quit rates and other secondary outcomes

12 months

Extended Follow-up

Assess the rates of tobacco treatment delivery over an extended period

36 months

Treatment Details

Interventions

• iEHR + Navigator

Trial Overview The study is testing an electronic health record-based approach combined with support from a community health navigator, aiming to help families quit smoking. It will compare how well this new strategy works against the usual care given for smoking cessation in pediatric settings.

Participant Groups

Group I: iEHR + Navigator Experimental Treatment 1 Intervention

Group II: Usual Care Control Active Control 1 Intervention

Usual care delivery in pediatric primary care offices.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+