CClinicalTrials.gg
CompletedNCT01611714EDITUpdated Jan 29, 2016

Equity in Diagnostic Imaging Trial

An interventional study of Audit-feedback and Clinical Decision Support in Headache, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Headache

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Keywords

  • Racial/ethnic disparities
  • Imaging
  • Emergency
  • Headache
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In context

Headache

1,226 studies on the registry are indexed under Headache; 203 are open to participants now.

This study's enrollment of 181 is above the median of 60 across 919 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • anyone who does not meet the inclusion criteria will be excluded from the study
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    Audit-feedback

    Arm 1: Audit-feedback only

    Other: Audit-feedback

  • Experimental
    CDS message

    Arm 2: CDS message only

    Other: Clinical Decision Support

  • Experimental
    Both Interventions

    Arm 3: Audit-feedback and CDS message

    Other: Audit-feedback · Other: Clinical Decision Support

  • No intervention
    Control

    Arm 4: Control

Interventions

  • OtherAudit-feedback

    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.

  • OtherClinical Decision Support

    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.

    Also known as: CDS

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 24 months

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Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01611714
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Jun 5, 2012
Start date
Jul 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 29, 2016

Study contacts

Lynne D Richardson, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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