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Clinical Decision Support (CDS) for Outpatient Radiology Imaging
Last registered on June 28, 2016

Pre-Trial

Trial Information
General Information
Title
Clinical Decision Support (CDS) for Outpatient Radiology Imaging
RCT ID
AEARCTR-0000905
Initial registration date
October 16, 2015
Last updated
June 28, 2016 10:34 AM EDT
Location(s)
Primary Investigator
Affiliation
MIT
Other Primary Investigator(s)
PI Affiliation
The Mount Sinai Health System
PI Affiliation
The Mount Sinai Health System
PI Affiliation
The Mount Sinai Health System
PI Affiliation
Brown University
PI Affiliation
The Mount Sinai Health System
PI Affiliation
J-PAL North America
PI Affiliation
MIT
Additional Trial Information
Status
Withdrawn
Start date
2015-03-21
End date
2016-05-16
Secondary IDs
JPAL-3872
Abstract
The goal of the study is to determine whether clinical decision support (CDS) for outpatient radiology affects the number, type, or appropriateness of targeted high-cost radiology images (i.e. MR and CT) ordered. The CDS will be delivered to outpatient physicians in the Mount Sinai Health System in New York City. It will be delivered in Epic, an industry-standard electronic medical record software, through ACRSelect, which is a leading decision support tool based on the American College of Radiology (ACR) Appropriateness Criteria (see http://www.acr.org/Quality-Safety/Appropriateness-Criteria), and presents the ACR appropriateness scores for each image on a scale of 1-9 with 1-3 labelled as ‘usually not appropriate’, 4-6 ‘May be appropriate’, and 7-9 ‘usually appropriate’.
External Link(s)
Registration Citation
Citation
Darrow, Bruce et al. 2016. "Clinical Decision Support (CDS) for Outpatient Radiology Imaging." AEA RCT Registry. June 28. https://doi.org/10.1257/rct.905-8.0.
Former Citation
Darrow, Bruce et al. 2016. "Clinical Decision Support (CDS) for Outpatient Radiology Imaging." AEA RCT Registry. June 28. https://www.socialscienceregistry.org/trials/905/history/9109.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Treatment group providers will receive Clinical Decision Support at the time of ordering CT or MR images. A pop-up screen providing CDS will appear at physician sign-off for all CT or MR scans scored 1-3, and scans scored 4-6 for which an alternative scan scored 7-9 exists.
This screen will show the appropriateness score of the original scan order, and will display any alternative scans that are scored 7-9 for the same indications and patient characteristics. It will also display a link to relevant ACR documentation relevant to the selected scan and indication.
Any time the pop-up alert appears, a checkbox removing the selected scan from unsigned orders will be checked by default.
Intervention Start Date
2015-10-27
Intervention End Date
2016-05-16
Primary Outcomes
Primary Outcomes (end points)
Primary Outcome Measure:
• Number of "non-advised" scans ordered per visiting provider
[Time Frame: first 365 days after CDS is turned on for the treatment group] [Safety Issue: No]
"non-advised" scans are (a) all magnetic resonance (MR) or computed tomography (CT) scans that ACR Select rates 1-3 ("usually not appropriate"), and (b) all MR or CT scans rated 4-6 ("may be appropriate") for which an alternative scan (MR, CT, or other modality) rated 7-9 ("usually appropriate") exists


Secondary Outcome Measures:
• Number of scans ordered per visiting provider that ACR Select rates 1-3 ("usually not appropriate")
[Time Frame: first 365 days after CDS is turned on for the treatment group] [Safety Issue: No]
includes magnetic resonance (MR) and computed tomography (CT) scans scored by ACR Select

• Number of scans ordered per visiting provider that ACR Select rates 4-6 ("may be appropriate") for which an alternative scan (MR, CT, or other modality) rated 7-9 ("usually appropriate") exists
[Time Frame: first 365 days after CDS is turned on for the treatment group] [Safety Issue: No]
includes magnetic resonance (MR) and computed tomography (CT) scans scored by ACR Select
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Inclusion criteria:
• Outpatient medical provider with scan ordering permissions at Mount Sinai Hospital or Mount Sinai Queens
• Has an active ID in the Epic electronic medical record ordering system

Exclusion criteria:
• Opted out of the study prior to October 13, 2015

Providers were randomly allocated equally into treatment or control groups with no stratification.
Experimental Design Details
Randomization Method
Randomization done in office by a computer (Stata)
Randomization Unit
Visiting provider (individual)
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
2038 providers
Sample size: planned number of observations
2038 providers
Sample size (or number of clusters) by treatment arms
1019 control, 1019 treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Using historical data from the electronic medical record at Mount Sinai health system spanning January 1st, 2012 to December 31st, 2013, we performed power calculations by: repeatedly simulating data under an assumed model of the effects of CDS on targeted high-cost (HC) scans, estimating a statistical model on the simulated data, and computing the fraction of simulations in which we were able to reject the null hypothesis of no effect. Our review of observational studies finds that when CDS was implemented in comparable outpatient settings for MR and CT scans, the roll-out of CDS correlated with a 20 to 30% reduction in high cost scan volume (Blackmore et al., 2011; Ip et al., 2014, 2013; Solberg et al., 2010). We therefore examined whether the study was powered to detect a 20% reduction in targeted high cost scans. After 1,000 simulations, we found 80.0% power to detect a 19.7% reduction in our primary outcome, assuming a 95% confidence interval: our minimum detectable effect size is - 4.896 targeted high cost scans associated with visiting provider after 12 months (compared to a control group mean of 24.883 targeted high cost scans per provider). Our average standard error across the 1,000 simulations was 1.723 targeted high cost scans.
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Icahn School of Medicine at Mount Sinai
IRB Approval Date
2015-05-01
IRB Approval Number
1401092
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal

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Intervention
Is the intervention completed?
Yes
Intervention Completion Date
May 16, 2016, 12:00 AM +00:00
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers