- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611714
Equity in Diagnostic Imaging Trial (EDIT)
Equity in Diagnostic Imaging Trial (EDIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
Other Names:
|
|
Experimental: 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.
Other Names:
|
|
No Intervention: Control
Arm 4: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in CT usage rate
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lynne D Richardson, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 02-0515(3)
- 3P60MD000270-09S1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.