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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help parents who smoke quit by using an electronic health record system (iEHR) and support from a community health navigator. It aims to determine if this method is more effective than the usual care in pediatric settings. Participants include parents or guardians who smoke and have children seeing a participating child healthcare provider. The trial focuses on creating smoke-free homes and cars while offering personalized support. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health outcomes for families.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this iEHR + Navigator approach is safe?

Research shows that using electronic health records (EHRs) and community health navigators is generally safe. Studies have found that participants tolerate these methods well. They enhance smoking cessation by improving how healthcare providers track and support efforts to quit.

For example, one study found that using an EHR system to assist staff in tobacco cessation care was effective, with no serious safety issues reported. Another study showed that about a quarter of participants attempted to quit smoking when EHR-based strategies were used.

These findings suggest that the iEHR + Navigator approach safely aids smoking cessation, with no major risks reported in similar past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eCEASE Program for Smoking Cessation because it integrates an innovative approach using the iEHR (integrated electronic health record) combined with a Navigator system. Unlike traditional methods like nicotine replacement therapies or medication, this program taps into digital tools and personalized guidance to help individuals quit smoking. The use of iEHR helps streamline and customize patient information, while the Navigator provides real-time support and motivation, making the quitting process more dynamic and potentially more effective. This blend of technology and personal interaction is what sets it apart from the standard cessation options.

What evidence suggests that the iEHR + Navigator strategy is effective for smoking cessation?

Research shows that the iEHR + Navigator method, which participants in this trial may receive, can help people quit smoking. Previous studies found that this approach increased treatment use among parents and reduced their smoking. In one study, almost half of the parents who used this method smoked less. Another study demonstrated that guidance and rewards helped people quit smoking at a city hospital. These results suggest that combining electronic health records with a community health guide can help families stop smoking. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656875/

Assessing the effects of Enhanced Multicomponent ... Estimates from our previous pilot studies of the TE intervention demonstrated improvements (47% vs 45%) among veterans [24] and (37% vs 15%) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9540977/

An EHR-automated and theory-based population health ... Primary outcomes were treatment engagement, utilization, and self-reported smoking cessation. In the PHM arm, 25.8% of participants engaged in treatment, 21.6% ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838073

Automated Tobacco Cessation Intervention for Parents in ... The trial showed significantly increased treatment engagement and reductions in cigarette use, with nearly half of parents in the intervention ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2659556

Effect of Patient Navigation and Financial Incentives on ... Among smokers at an urban safety-net hospital, navigation and incentives for smoking cessation significantly increased smoking cessation rates.

5. nature.com nature.com/articles/s43856-024-00624-6

Increasing digital equity to promote online smoking ... Our 12-week study retention rate (42%) is lower than prior telehealth smoking intervention studies at the same time point ranging from 57%-88%.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5820724/

Effect of Patient Navigation and Financial Incentives on ... The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results. Among 352 patients who were randomized (mean [SD] ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335522000067

Factors associated with smoking cessation attempts in a ... In our study, we used EHR data to measure cessation attempts in a safety-net setting. About a quarter of individuals who smoked made any cessation attempt.

8. link.springer.com link.springer.com/article/10.1007/s11606-020-06030-7

12-Month Evaluation of an EHR-Supported Staff Role ... Outcomes assessed from the EHR include performance of tobacco cessation care tasks, referral contact, and enrollment rates for the quitline (QL) ...

9. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20997-6

Assessing the effects of Enhanced Multicomponent Proactive ... This study will examine if the enhanced suite of services offers insights on how to best integrate evidence-based tobacco treatment services into usual care.