NCT02578290

Brief Summary

The goal of the study is to determine whether clinical decision support (CDS) affects the number, type, or appropriateness of targeted high-cost radiology images (i.e. MR and CT) ordered. The CDS will be delivered in Epic through ACRSelect software, 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'.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2,033

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

October 15, 2015

Last Update Submit

January 23, 2017

Conditions

CT and MR Image Orders

Keywords

decision support systemsclinical

Outcome Measures

Primary Outcomes (1)

  • number of "non-advised" scans ordered per visiting provider

    "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

    first 365 days after CDS is turned on for the treatment group

Secondary Outcomes (2)

  • Number of scans ordered per visiting provider that ACR Select rates 1-3 ("usually not appropriate")

    first 365 days after CDS is turned on for the treatment group

  • 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

    first 365 days after CDS is turned on for the treatment group

Study Arms (2)

Treatment

EXPERIMENTAL

Clinical Decision Support (CDS)

Other: Clinical Decision Support (CDS)

Control

NO INTERVENTION

Will not receive Clinical Decision Support (CDS)

Interventions

Clinical Decision Support (CDS)OTHER

A best practices alert (BPA) pop-up screen providing CDS will appear at physician sign-off for all 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.

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Queens

Long Island City, New York, 11102, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (11)

  • Centers for Medicare & Medicaid Services, 2013. National Health Expenditures 2013 Highlights. Centers for Medicare & Medicaid Services.

    BACKGROUND

  • Callaghan BC, Kerber KA, Pace RJ, Skolarus LE, Burke JF. Headaches and neuroimaging: high utilization and costs despite guidelines. JAMA Intern Med. 2014 May;174(5):819-21. doi: 10.1001/jamainternmed.2014.173. No abstract available.

    PMID: 24638246BACKGROUND

  • Sherman, D., 2012. Stemming the tide of overtreatment in U.S. healthcare. Reuters. Feb 16, 2012.

    BACKGROUND

  • U.S. Government Accountability Office, 2008. Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices [WWW Document]. URL http://www.gao.gov/products/GAO-08-452 (accessed 2.23.15).

    BACKGROUND

  • Consumer Reports, 2015. Surprising Dangers of CT Scans and X-rays - Consumer Reports [WWW Document]. URL http://www.consumerreports.org/cro/magazine/2015/01/the-surprising-dangers-of-ct-sans-and-x-rays/index.htm (accessed 2.25.15).

    BACKGROUND

  • Dehn, T.G., O'Connell, B., Hall, R.N., Moulton, T., 2000. Appropriateness of imaging examinations: current state and future approaches. Imaging Econ 13, 18-26.

    BACKGROUND

  • Georgiou A, Prgomet M, Markewycz A, Adams E, Westbrook JI. The impact of computerized provider order entry systems on medical-imaging services: a systematic review. J Am Med Inform Assoc. 2011 May 1;18(3):335-40. doi: 10.1136/amiajnl-2010-000043. Epub 2011 Mar 8.

    PMID: 21385821BACKGROUND

  • Medicare Payment Advisory Commission, 2014. Health Care Spending and the Medicare Program. MedPAC.

    BACKGROUND

  • Shreibati JB, Baker LC. The relationship between low back magnetic resonance imaging, surgery, and spending: impact of physician self-referral status. Health Serv Res. 2011 Oct;46(5):1362-81. doi: 10.1111/j.1475-6773.2011.01265.x. Epub 2011 Apr 21.

    PMID: 21517834BACKGROUND

  • Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

    PMID: 18046031BACKGROUND

  • Pitts, J., 2014. The Protecting Access to Medicare Act of 2014.

    BACKGROUND

Study Officials

  • Amy Finkelstein, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Madhu Mazumdar, Mazumdar

    The Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

  • Bruce Darrow, MD, PhD

    The Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

  • Joseph Kannry, MD

    The Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

  • David S Mendelson, MD FACR

    The Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

  • Joseph Doyle, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Jesse Shapiro, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Laura Feeney, MA

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 16, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(2)