- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03449862
Key Information Can Influence Clinician Ordering of Brain CTs
22. februar 2018 opdateret af: Clemson University
Effect of Clinical Decision Rules, Patient Cost and Malpractice Information on Clinician Brain CT Image Ordering: a Randomized Controlled Trial
The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns.
Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians.
Using simulation, we explored whether the presentation of a clinical decision rule (i.e.
Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering.
Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Multi-center, double-blinded simulation-based randomized controlled trial.
Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient.
This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order.
The malpractice and cost information differed by assigned group to test the any temporal relationship.
The simulation closed with a second vignette and an imaging decision.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
167
Fase
- Ikke anvendelig
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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinician (physician, nurse practitioner, physician assistant) licensed to deliver health care.
- Actively employed to deliver health care in the emergency department of Greenville health System (South Carolina) or Emory University (Georgia)
Exclusion Criteria:
- None
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: LEGAL-COST
Clinicians were first presented malpractice case law summary information (which suggests clinician not likely to be sued for not ordering CT scan) then patient out-of-pocket cost information for brain CT image (which provides them insight into what the patient is likely to pay for the test)
|
Clinicians asked to make decision on medical imaging for their simulated patient after presentation of clinical case then additional information.
At each presentation of new information the clinician may modify their image order.
|
Aktiv komparator: COST-LEGAL
Clinicians were first presented with patient out-of-pocket cost information for brain CT image (which provides them insight into what the patient is likely to pay for the test) then malpractice case law summary information (which suggests clinician not likely to be sued for not ordering CT scan)
|
Clinicians asked to make decision on medical imaging for their simulated patient after presentation of clinical case then additional information.
At each presentation of new information the clinician may modify their image order.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
brain CT medical image order
Tidsramme: 30 days
|
At each decision point clinician asked to decide on which image to order for patient among three choices:
|
30 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ronald W. Gimbel, PHD, Clemson University
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.
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)
31. august 2016
Primær færdiggørelse (Faktiske)
11. april 2017
Studieafslutning (Faktiske)
13. februar 2018
Datoer for studieregistrering
Først indsendt
14. februar 2018
Først indsendt, der opfyldte QC-kriterier
22. februar 2018
Først opslået (Faktiske)
28. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro00054122
Plan for individuelle deltagerdata (IPD)
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