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CT, MR, NM, and PET Image OrdersNCT02996045

Clinical Decision Support (CDS) for Radiology Imaging

A study testing Clinical Decision Support (CDS) in people with CT, MR, NM, and PET Image Orders, run by Abdul Latif Jameel Poverty Action Lab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the study is to determine whether clinical decision support (CDS) for radiology affects the number, type, or appropriateness of targeted high-cost radiology imaging orders (i.e. magnetic resonance (MR), computed tomography (CT), nuclear medicine (NM) and Positron Emission Tomography (PET) scans). Read more about this study

Who is it for?
Any age
Conditions the study is for
CT, MR, NM, and PET Image Orders
What is being tested?
Clinical Decision Support (CDS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,511 participants
Where
1 siteUnited States
Study dates
15 Dec 2016to Dec 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 imaging order permissions at Aurora Health Care.
  • Has at least one high- or low-cost imaging order in the year from November 1, 2015 to November 1, 2016 or is medical resident who joined Aurora since that time.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Aurora Health Care

    Milwaukee, Wisconsin, 53204

Other trials in United States

About this study

Official title: The Impact of Clinical Decision Support (CDS) for Radiology: A Randomized Control Trial

The goal of the study is to determine whether clinical decision support (CDS) for radiology affects the number, type, or appropriateness of targeted high-cost radiology imaging orders (i.e. magnetic resonance (MR), computed tomography (CT), nuclear medicine (NM) and Positron Emission Tomography (PET) scans). The CDS will be delivered to physicians in the Aurora Health Care system. 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). The ACR Select tool rates imaging orders on a scale of 1-9 with 1-3 labelled as 'usually not appropriate', 4-6 'May be appropriate', and 7-9 'usually appropriate'.

Read the detailed description

With healthcare spending accounting for almost one-fifth of the U.S. economy and an even larger share of public sector budgets, there is substantial interest in innovations in healthcare delivery that can reduce the "over use" of resources that have no or low value to patients. As a result, there is a key need for rigorous evidence on scalable interventions aimed at improving the efficiency of the U.S. healthcare sector in general, and in the public sector in particular, which accounts for $1.25 trillion in annual healthcare spending.

In particular, there is widespread concern in both the medical profession and the public sector of the cost and health risks of "over-scanning". Estimates suggest that as many as 30% of imaging in the U.S. are unnecessary. Medicare direct spending on "high-cost" scans (e.g. MRs and CTs) was about $10 billion in 2012, or about 2% of total Medicare costs ; the indirect costs are likely considerably greater, since imaging often triggers additional follow up care. It is also estimated that about 2 percent of cancers in the U.S. are due to CT use.

Reflecting this concern, starting in 2018 Medicare will no longer reimburse for high-cost scans unless ordered using an "acceptable" Clinical Decision Support (CDS) system. Despite this upcoming policy change, the investigators know of no large-scale randomized trials on the impact of CDS for imaging.

The intervention in this study provides Clinical Decision Support (CDS) for targeted high-cost radiology orders, (MR, CT, NM, and PET scans), to healthcare providers treating patients in settings affiliated with the Aurora Health Care system headquartered in Wisconsin. CDS is a tool embedded in an order entry system that provides information and guidance to providers on whether their intended order is "appropriate" and whether there are more highly recommended alternatives. The randomization is at the provider level: half will receive the CDS, while the remaining half of providers in the study will serve as the control group.

The CDS will be delivered through the order-entry software, Epic, through ACR Select software, which is a leading decision support tool based on the American College of Radiology (ACR) Appropriateness Criteria.

Recommendations that appear in the CDS tool are a digitized version of guidelines created by the American College of Radiology (ACR). The guidelines score the appropriateness of a scan order for a given health indication, where indications include common symptoms and diagnosis keywords, such as "acute headache." In particular, indication-scan pairs are assigned an "appropriateness rating" from 1-9. Scores 1-3 are 'usually not appropriate,' 4-6 are 'may be appropriate,' and 7-9 are 'usually appropriate.'

To learn more about how CDS impacts ordering behavior, the investigators will investigate whether those exposed to CDS orders in ways that avoids CDS, such as placing them via clerical workers or choosing different indications. The investigators plan to analyze outcomes across different settings (Inpatient vs Outpatient and in the ED). Last, if the investigators find effects of CDS on ordering they will examine effects on utilization, including length of inpatient stays.

The primary outcome is the number of imaging orders that would produce a best-practice alert suggesting a change. The investigators conducted power calculations using a 7-month intervention window and 6 months of pre-period data to calculate the lag of the dependent variable as a control. With this control, the minimum detectible effect is a 13% reduction compared to a mean of 11 scans over that time period.

In addition, the investigators will investigate the number of scans (all high-cost, high-cost scoring 1-3, high-cost scoring 4-6, and substitution to low-cost scans. The investigators will also investigate whether treatment group orders in ways that avoids the CDS, such as placing them via clerical workers or choosing different indications. The investigators plan to analyze outcomes across different settings (Inpatient vs Outpatient and in the ED). Last, if the investigators find effects of CDS on ordering they will examine effects on utilization, including length of inpatient stays.

Being tested
Clinical Decision Support (CDS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 1-6, 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.

Study groups in NCT02996045
Study groupRoleWhat they receive
TreatmentExperimentalClinical Decision Support (CDS)
Receives: Other: Clinical Decision Support (CDS)
ControlNo interventionWill not receive Clinical Decision Support (CDS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of scans ordered that would be subject to the CDS best practice alert

    Scans where the CDS would be triggered based on the criteria listed in the intervention description

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

Secondary outcomes (3)
  1. Number of high-cost scans (CT, MR, NM and PET) ordered

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

  2. Number of scans ordered that would be subject to the CDS best practice alert and that ACR Select rates 1-3 ("usually not appropriate")

    Scans where the CDS would be triggered and scored 1-3 based on the criteria listed in the intervention description.

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

  3. Number of scans ordered that would be subject to the CDS best practice alert and that ACR Select rates 4-6 ("may be appropriate")

    Scans where the CDS would be triggered and scored 4-6 based on the criteria listed in the intervention description.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study start15 Dec 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
Parallel groups
Enrolment
3,511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02996045
Sponsor's protocol ID
JPAL-5002
Status last verified
Jul 2020
First submitted
15 Dec 2016
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24638246
  • 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.

    PubMed 21385821
  • 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.

    PubMed 21517834
  • 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.

    PubMed 18046031
  • Centers for Medicare & Medicaid Services, 2013. National Health Expenditures 2013 Highlights. Centers for Medicare & Medicaid Services.

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

  • 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).

  • 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).

  • 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.

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support (CDS) in people with CT, MR, NM, and PET Image Orders, run by Abdul Latif Jameel Poverty Action Lab 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 15 Jul 2020. 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02996045, which also lists 11 linked publications.

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 15 Jul 2020.

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