eCEASE to Support Treatment for Parental Tobacco Use

Study Overview
=================
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.

Official Title
-----------------
Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use

Conditions
-----------------
Tobacco Smoking, Second Hand Tobacco Smoke, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: iEHR + Navigator


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Parent/legal guardian does not speak English; No telephone; and Prior enrollment in the study during a previous visit.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-arm Randomized Control Trial with a stratified cluster randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iEHR + Navigator<br> | Behavioral: iEHR + Navigator<br>* 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.<br>|
| No Intervention: Usual Care Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family tobacco screening, Tobacco cessation