- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02489708
Pediatric Emergency Department Decision Support System to Reduce Secondhand Smoke
7. december 2021 opdateret af: Children's Hospital Medical Center, Cincinnati
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 dag og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Rate of Use of Decision Support System by Nurses
Tidsramme: 3 months
|
3 months
|
Change in Amount of Second Hand Smoke Exposure in Children
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: E. Melinda Mahabee-Gittens, MD, MS, Professor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2014
Primær færdiggørelse (Faktiske)
1. december 2021
Studieafslutning (Faktiske)
1. december 2021
Datoer for studieregistrering
Først indsendt
28. maj 2015
Først indsendt, der opfyldte QC-kriterier
1. juli 2015
Først opslået (Skøn)
3. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CINC 2014-5592
- 1R21CA184337-01A1 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Cessation Counseling
-
Northwestern UniversityGeorgetown UniversityTilmelding efter invitationKroniske nyresygdomme | Genetisk dispositionForenede Stater
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbejdspartnereRekruttering
-
Texas Christian UniversityAfsluttetMapping Enhanced Counseling (MEC) | Active Linkage (AL)Forenede Stater
-
University of MalayaUniversity of Hawaii Cancer Research Center; University of GuamIkke rekrutterer endnuTobaksophør | Betel nødde tyggemaskineMalaysia
-
Duke Kunshan UniversityAfsluttet
-
Texas Christian UniversityAktiv, ikke rekrutterendeKortlægningsmetoder til forberedelse af implementeringsoverførsel | Behandlingsparathed og introduktionsprogramForenede Stater
-
University of TartuState University of New York - Downstate Medical Center; Tibotec Pharmaceutical...AfsluttetErhvervet immundefektsyndrom | Medicinadhærens | Akut HIV-infektionEstland
-
Kristin AshfordNational Institute on Drug Abuse (NIDA)Afsluttet
-
Makerere UniversityMinistry of Health, Uganda; Rakai Health Sciences ProjectAktiv, ikke rekrutterende
-
University of California, San DiegoKenya Ministry of Health; Population Council KenyaRekruttering