NCT02489708

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

7.1 years

First QC Date

May 28, 2015

Last Update Submit

December 7, 2021

Conditions

Keywords

BronchiolitisCoughEar InfectionRespiratory InfectionWheezingClinical Decision Support Systems

Outcome Measures

Primary Outcomes (2)

  • Change in Rate of Use of Decision Support System by Nurses

    3 months

  • Change in Amount of Second Hand Smoke Exposure in Children

    3 months

Study Arms (1)

Cessation Counseling

EXPERIMENTAL

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.

Behavioral: Cessation Counseling

Interventions

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.

Cessation Counseling

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non English speaking families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

AsthmaSmoking CessationBronchiolitisCoughOtitisRespiratory Tract InfectionsRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHealth BehaviorBehaviorBronchitisInfectionsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • E. Melinda Mahabee-Gittens, MD, MS

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

July 3, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations