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Equity in Diagnostic Imaging Trial (EDIT)

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit-feedback
Clinical Decision Support
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Headache focused on measuring Racial/ethnic disparities, Imaging, Emergency, Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Audit-feedback

CDS message

Both Interventions

Control

Arm Description

Arm 1: Audit-feedback only

Arm 2: CDS message only

Arm 3: Audit-feedback and CDS message

Arm 4: Control

Outcomes

Primary Outcome Measures

Change in CT usage rate
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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2012
Last Updated
January 28, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01611714
Brief Title
Equity in Diagnostic Imaging Trial
Acronym
EDIT
Official Title
Equity in Diagnostic Imaging Trial (EDIT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will 1) Develop two interventions: a) an audit-feedback email intervention that provides clinicians with data on CT scan ordering practices by patient race; and b) a clinical decision support (CDS) message in the electronic medical record headache template; and 2) Compare the effectiveness of these 2 interventions in eliminating a previously observed Black-White disparity in CT scanning rates to rule out subarachnoid hemorrhage (SAH).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Racial/ethnic disparities, Imaging, Emergency, Headache

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Audit-feedback
Arm Type
Experimental
Arm Description
Arm 1: Audit-feedback only
Arm Title
CDS message
Arm Type
Experimental
Arm Description
Arm 2: CDS message only
Arm Title
Both Interventions
Arm Type
Experimental
Arm Description
Arm 3: Audit-feedback and CDS message
Arm Title
Control
Arm Type
No Intervention
Arm Description
Arm 4: Control
Intervention Type
Other
Intervention Name(s)
Audit-feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support
Other Intervention Name(s)
CDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CT usage rate
Description
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.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne D Richardson, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Equity in Diagnostic Imaging Trial

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