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Clinical Decision Support (CDS) for Radiology Imaging: A Randomized Control Trial

Last registered on March 16, 2017

Pre-Trial

Trial Information

General Information

Title
Clinical Decision Support (CDS) for Radiology Imaging: A Randomized Control Trial
RCT ID
AEARCTR-0001846
Initial registration date
December 14, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
December 14, 2016, 5:20 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
March 16, 2017, 1:38 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Primary Investigator

Affiliation
MIT

Other Primary Investigator(s)

PI Affiliation
MIT
PI Affiliation
MIT
PI Affiliation
Aurora Health Care
PI Affiliation
MIT
PI Affiliation
MIT

Additional Trial Information

Status
In development
Start date
2015-10-27
End date
2021-11-30
Secondary IDs
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, CT, NM, PET) ordered. The CDS will be delivered to physicians in the Aurora Health Care system in Wisconsin. It will be delivered in Epic, an industry-standard electronic medical record software, through ACR Select, 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
Abraham, Sarah et al. 2017. "Clinical Decision Support (CDS) for Radiology Imaging: A Randomized Control Trial." AEA RCT Registry. March 16. https://doi.org/10.1257/rct.1846-3.0
Former Citation
Abraham, Sarah et al. 2017. "Clinical Decision Support (CDS) for Radiology Imaging: A Randomized Control Trial." AEA RCT Registry. March 16. https://www.socialscienceregistry.org/trials/1846/history/15061
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Clinical Decision Support Treatment:
A best practices alert (BPA) pop-up screen providing CDS will appear at physician sign-off for all scans scored 1-6, and scans scored 7-8 for which an alternative scan scored 8-9 exists.
This screen will show the appropriateness score of the original scan order, and will display up to 7 alternative scans that are scored >4 and greater than or equal to the original score for the same indications and patient characteristics. It will also display a link to relevant ACR documentation relevant to the selected scan and indication.
Intervention Start Date
2016-12-15
Intervention End Date
2017-12-15

Primary Outcomes

Primary Outcomes (end points)
Primary Outcome Measure:

1. Number of scans ordered that would be subject to the CDS best practice alert
[Time Frame: first 365 days after CDS is turned on for the treatment group]
Definition: Scans where the CDS would be triggered based on the criteria listed in the intervention description.

Secondary Outcome Measures:

2. Number of high-cost scans (CT, MR, NM and PET) ordered
[Time Frame: first 365 days after CDS is turned on for the treatment group]
Definition: includes CT, MR, NM and PET scans ordered and performed.

3. Number of scans ordered that would be subject to the CDS best practice alert and that ACR Select rates 1-3 ("usually not appropriate")
[Time Frame: first 365 days after CDS is turned on for the treatment group]
Definition: Scans where the CDS would be triggered and scored 1-3 based on the criteria listed in the intervention description.

4. Number of scans ordered that would be subject to the CDS best practice alert and that ACR Select rates 4-6 ("may be appropriate")
[Time Frame: first 365 days after CDS is turned on for the treatment group]
Definition: Scans where the CDS would be triggered and scored 4-6 based on the criteria listed in the intervention description.

Other pre-specified outcomes

1. Number of low-cost scans ordered
[Time Frame: first 365 days after CDS is turned on for the treatment group]
Definition: includes X-rays, ultra sounds, mammograms, fluoroscopy and bone densitometry
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Inclusion criteria:
• Medical provider actively employed at Aurora with a valid Epic log-in.
• Is a Medical Doctor (MD), Doctors of Osteopathic Medicine (DO), podiatrist (DPM), nurse practitioner (NP), physician assistant (PA), or certified nurse midwife (CNM)
• Has with imaging order permissions at Aurora Health Care.
• Providers had at least one high- or low-cost imaging order in the year from November 1, 2015 or a medical resident who joined Aurora since that time.

Exclusion criteria:
• Opted out of the study prior to November 24, 2016

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
Health care provider (individual)
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
3511 providers
Sample size: planned number of observations
3511 providers
Sample size (or number of clusters) by treatment arms
1,756 control, 1,755 treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Using historical data from the electronic medical record at Aurora Health Care spanning November 1, 2015 to December 6, 2016 we performed power calculations using parametric and nonparametric (simulation) methods: 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. Results are very similar regardless of the method. Using a 7-month intervention window and a six-month pre-period to calculate the lag of the dependent variable, we calculate a minimum detectable effect (MDE) of -1.5 scan orders that would trigger the BPA (a 13% reduction compared to the mean of 11.1 imaging orders with a standard deviation of 23.8). For high-cost scans our MDE is -3 (7% of the mean of 47 scans and a standard deviation of 93), -0.6 imaging orders scored 1-3 (19% compared to a mean of 3.1 and a standard deviation of 8.0). This compares favorably to 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 20-70% reduction in the rate of “inappropriate” scanning by 20-70% and a 20 to 30% reduction in high cost scan volume (Blackmore et al., 2011; Ip et al., 2014, 2013; Lehnert et al., 2010, Solberg et al., 2010).
IRB

Institutional Review Boards (IRBs)

IRB Name
Aurora Health Care, Inc. Institutional Review Board
IRB Approval Date
2016-03-09
IRB Approval Number
15-138E
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials