NCT01611714

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

5.4 years

First QC Date

April 13, 2012

Last Update Submit

January 28, 2016

Conditions

Keywords

Racial/ethnic disparitiesImagingEmergencyHeadache

Outcome Measures

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.

    up to 24 months

Study Arms (4)

Audit-feedback

EXPERIMENTAL

Arm 1: Audit-feedback only

Other: Audit-feedback

CDS message

EXPERIMENTAL

Arm 2: CDS message only

Other: Clinical Decision Support

Both Interventions

EXPERIMENTAL

Arm 3: Audit-feedback and CDS message

Other: Audit-feedbackOther: Clinical Decision Support

Control

NO INTERVENTION

Arm 4: Control

Interventions

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.

Audit-feedbackBoth Interventions

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
Both InterventionsCDS message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

HeadacheEmergencies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Lynne D Richardson, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

June 5, 2012

Study Start

July 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations