HeadacheEDITNCT01611714
Equity in Diagnostic Imaging Trial
A study testing Audit-feedback and Clinical Decision Support in people with Headache, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Audit-feedback and Clinical Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- anyone who does not meet the inclusion criteria will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Equity in Diagnostic Imaging Trial (EDIT)
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.
- Conditions
- Headache
- Being tested
- Audit-feedback, Clinical Decision Support
- Keywords
- Racial/ethnic disparities, Imaging, Emergency, Headache
- Medical subject headings
- Headache, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit-feedbackOther
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.
Clinical Decision SupportOther
Also called CDS
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.
| Study group | Role | What they receive |
|---|---|---|
| Audit-feedback | Experimental | Arm 1: Audit-feedback only Receives: Other: Audit-feedback |
| CDS message | Experimental | Arm 2: CDS message only Receives: Other: Clinical Decision Support |
| Both Interventions | Experimental | Arm 3: Audit-feedback and CDS message Receives: Other: Audit-feedback; Other: Clinical Decision Support |
| Control | No intervention | Arm 4: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lynne D Richardson, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611714
- Sponsor's protocol ID
- GCO 02-0515(3)
- Other IDs
- 3P60MD000270-09S1
- Acronym
- EDIT
- Status last verified
- Jan 2016
- First submitted
- 13 Apr 2012
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity in Diagnostic Imaging Trial (EDIT)
- ClinicalTrials.gov ID
- NCT01611714
- Acronym / sponsor ID
- EDIT / GCO 02-0515(3)
- Conditions
- Headache
- Keywords
- Racial/ethnic disparities, Imaging, Emergency, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jul 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Audit-feedback | Experimental | Other: Audit-feedbackArm 1: Audit-feedback only |
| CDS message | Experimental | Other: Clinical Decision SupportArm 2: CDS message only |
| Both Interventions | Experimental | Other: Audit-feedback, Other: Clinical Decision SupportArm 3: Audit-feedback and CDS message |
| Control | No intervention | –Arm 4: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- anyone who does not meet the inclusion criteria will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit-feedbackClinicians 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. | Other | Audit-feedback, Both Interventions |
| Clinical Decision SupportAlso: CDSClinicians 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 | Both Interventions, CDS message |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne D Richardson, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit-feedback and Clinical Decision Support in people with Headache, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CT usage rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.