- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01611714
Equity in Diagnostic Imaging Trial (EDIT)
Equity in Diagnostic Imaging Trial (EDIT)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Investigators at our institution (Hwang & Richardson)* documented a racial disparity in the use of CT scans to diagnose subarachnoid hemorrhage, (SAH) a life-threatening form of stroke. Subsequent analyses found a similar finding in NHAMCS, a national ED Visit database*. The investigators will compare the effectiveness of 1) an audit-feedback intervention that provides data on race-specific CT rates and 2) a clinical decision support (CDS) message in the electronic "headache" charting template in eliminating the previously observed Black-White disparity in CT rates to rule out SAH.
Study Setting: The adult section of the Mount Sinai Emergency Department, an urban academic department with an annual volume of over 70,000 adult visits and a patient population representing a diverse cross-section of race and socioeconomic groups. The adult patients are cared for by a staff that includes: attending physicians, physician assistants, emergency medicine resident physicians, and rotating resident physicians from other specialties. The department has a dedicated CT scanner that is readily available around the clock. Epic Production is used for all physician and nurse documentation and for all order entry (including CT scans).
Over a 24-month period the investigators will compare the intervention and control groups' rates of testing for SAH across races, controlling for patient acuity, age and co-morbidities. Because the close working relationships among the attending and resident physicians in our department may lead to knowledge diffusion, the intervention may change the behavior of the control group as well as the intervention group, thus leading to an underestimation of the intervention effect as measured by the between- groups difference. The investigators will use a time series design to allow us to evaluate this effect. 10 months after the implementation of the first intervention, the clinical decision support message will be implemented. The impact of each intervention will be evaluated using a repeated measures design using a mixed linear model.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Attending Physicians, Emergency Room Resident Physicians, and PA's will be included if:
- they provide care to adult patients in the emergency department of Mount Sinai Hospital.
Patients will be enrolled for medical record review if
- they present with a complaint of headache and charted on the headache template in the period between four years pre-intervention and the end of the study period.
Exclusion Criteria:
- anyone who does not meet the inclusion criteria will be excluded from the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Audit-feedback
Arm 1: Audit-feedback only
|
Clinicians will receive a short email educational message at regular intervals alerting them to the historic disparities in diagnostic workup for SAH in our department and reminding them of the increased risk of SAH among African-American patients.
|
Experimentell: CDS message
Arm 2: CDS message only
|
Clinicians receive an embedded real-time Best Practice Alert (BPA) of increased rates of SAH among African-Americans when they open the "headache" electronic charting template.
Andra namn:
|
Experimentell: Both Interventions
Arm 3: Audit-feedback and CDS message
|
Clinicians will receive a short email educational message at regular intervals alerting them to the historic disparities in diagnostic workup for SAH in our department and reminding them of the increased risk of SAH among African-American patients.
Clinicians receive an embedded real-time Best Practice Alert (BPA) of increased rates of SAH among African-Americans when they open the "headache" electronic charting template.
Andra namn:
|
Inget ingripande: Control
Arm 4: Control
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in CT usage rate
Tidsram: up to 24 months
|
What is the impact of the email intervention, CDS intervention, and combined intervention on black-white difference in CT rates?
A successful intervention should lead to a significant main effect for each experimental arm.
|
up to 24 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Lynne D Richardson, MD, Icahn School of Medicine at Mount Sinai
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GCO 02-0515(3)
- 3P60MD000270-09S1 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Audit-feedback
-
Groupe Hospitalier de la Region de Mulhouse et...AvslutadAlkoholmissbrukFrankrike
-
Brainmarc Ltd.OkändLätt kognitiv funktionsnedsättning
-
Semmelweis UniversityRekryteringHjärt-lungräddning | Grundläggande livsstöd | Premedicinsk utbildning | StudieteknikUngern
-
University of North Carolina, Chapel HillNational Institute on Deafness and Other Communication Disorders (NIDCD)AvslutadAfasi | Cerebrovaskulär olycka | Talets apraxiFörenta staterna
-
Universitätsklinikum Hamburg-EppendorfFederal Joint CommitteeAvslutad
-
Pusan National University HospitalAvslutadFysisk aktivitet | Metaboliskt syndrom | Bärbar enhetKorea, Republiken av
-
Aveiro UniversityAvslutadLändryggssmärtaPortugal
-
Children's Hospital Medical Center, CincinnatiAvslutad
-
University of British ColumbiaNational Council of Science and Technology, Mexico; UBC Peter Wall Institute...Avslutad
-
Yale UniversityNational Institute on Drug Abuse (NIDA)Avslutad