Pediatric Emergency Department Decision Support System to Reduce Secondhand Smoke

NCT ID: NCT02489708

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This two phase study will develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be the first to develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED. The investigators will conduct a two-phased project to develop, refine, and integrate a Decision Support System into the current electronic medical record system. In Phase I, the investigators will develop a three-part DSS with prompts to: 1) ASK about child SHSe and caregiver smoking 2) Use a software program (REDCap) to ADVISE caregivers to reduce their child's SHSe via total smoking home and car bans and quitting smoking, and 3) ASSIST caregivers to quit by directly connecting them to their choice of free cessation resources (e.g., Quitline, txt2quit, smokefree.gov) during the PED visit. If the investigators discover that a teen participant is a smoker, the investigators will provide them with resources for the Quitline, tx2quit, and teen.smokefree.gov. The investigators will create reports to provide feedback to nurses on their SHSe counseling behaviors. Nurses will provide input on program content, functions, and design. In Phase II, the investigators will conduct a 3-month feasibility trial to test the results of implementing the DSS on changes in nurse SHSe-related behaviors, and child and caregiver outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Smoking Cessation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bronchiolitis Cough Ear Infection Respiratory Infection Wheezing Clinical Decision Support Systems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cessation Counseling

Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention.

Group Type EXPERIMENTAL

Cessation Counseling

Intervention Type BEHAVIORAL

Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cessation Counseling

Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Nurses who work at least 2 shifts per week
* Current smokers accompanying their 0-18 year old child to the Emergency Department or Urgent Care

Exclusion Criteria

* Non English speaking families
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

E. Melinda Mahabee-Gittens, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Mahabee-Gittens EM, Dexheimer JW, Gordon JS. Development of a Tobacco Cessation Clinical Decision Support System for Pediatric Emergency Nurses. Comput Inform Nurs. 2016 Dec;34(12):560-569. doi: 10.1097/CIN.0000000000000267.

Reference Type RESULT
PMID: 27379524 (View on PubMed)

Mahabee-Gittens EM, Dexheimer JW, Khoury JC, Miller JA, Gordon JS. Development and Testing of a Computerized Decision Support System to Facilitate Brief Tobacco Cessation Treatment in the Pediatric Emergency Department: Proposal and Protocol. JMIR Res Protoc. 2016 Apr 20;5(2):e64. doi: 10.2196/resprot.4453.

Reference Type RESULT
PMID: 27098215 (View on PubMed)

Mahabee-Gittens EM, Dexheimer JW, Tabangin M, Khoury JC, Merianos AL, Stone L, Meyers GT, Gordon JS. An Electronic Health Record-Based Strategy to Address Child Tobacco Smoke Exposure. Am J Prev Med. 2018 Jan;54(1):64-71. doi: 10.1016/j.amepre.2017.08.011.

Reference Type DERIVED
PMID: 29102458 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R21CA184337-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINC 2014-5592

Identifier Type: -

Identifier Source: org_study_id