CT and MR Image OrdersNCT02578290
Clinical Decision Support (CDS) for Outpatient Radiology Imaging
A study testing Clinical Decision Support (CDS) in people with CT and MR Image Orders, run by Abdul Latif Jameel Poverty Action Lab at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CT and MR Image Orders
- What is being tested?
- Clinical Decision Support (CDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,033 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to May 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Opted out of the study prior to October 13, 2015
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Queens
Long Island City, New York, 11102
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: The Impact of Clinical Decision Support (CDS) for Outpatient Radiology Imaging: A Randomized Control Trial
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'.
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 (Centers for Medicare \& Medicaid Services, 2013).
In particular, there is widespread concern in both the medical profession (Callaghan et al., 2014; Sherman, 2012) and the public sector (U.S. Government Accountability Office, 2008) of the cost and health risks of "over-scanning". Estimates suggest that as many as 30% of imaging in the U.S. are unnecessary (Consumer Reports, 2015; Dehn et al., 2000; Georgiou et al., 2011). 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 (Medicare Payment Advisory Commission, 2014); the indirect costs are likely considerably greater, since imaging often triggers additional follow up care (Sherman, 2012; Shreibati and Baker, 2011). It is also estimated that about 2 percent of cancers in the U.S. are due to CT use (Brenner and Hall, 2007).
Reflecting this concern, starting in 2017 Medicare will no longer reimburse for high-cost scans unless ordered using an "acceptable" Clinical Decision Support (CDS) system (Pitts, 2014). Despite this upcoming policy change, we 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 and CT scans, to healthcare providers treating patients in outpatient settings affiliated with Mount Sinai Hospital and Mount Sinai Queens hospital in New York City. 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: one group will receive the CDS, while the remaining providers will serve as the control group.
The CDS will be delivered through the order-entry software, Epic, through ACRSelect 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 computerized 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.'
- Conditions
- CT and MR Image Orders
- Being tested
- Clinical Decision Support (CDS)
- Keywords
- decision support systems, clinical
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 1-3, 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Clinical Decision Support (CDS) Receives: Other: Clinical Decision Support (CDS) |
| Control | No intervention | Will not receive Clinical Decision Support (CDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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")
includes magnetic resonance (MR) and computed tomography (CT) scans scored by ACR Select
Measured: 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
includes magnetic resonance (MR) and computed tomography (CT) scans scored by ACR Select
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.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Due to an error in the implementation of the project, CDS was provided to all providers, rather than to the intended random sample of providers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CT and MR Image OrdersStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Latif Jameel Poverty Action Lab
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Amy Finkelstein, PhD, Principal investigator, Massachusetts Institute of TechnologyMadhu Mazumdar, Mazumdar, Principal investigator, The Mount Sinai Health SystemBruce Darrow, MD, PhD, Principal investigator, The Mount Sinai Health SystemJoseph Kannry, MD, Principal investigator, The Mount Sinai Health SystemDavid S Mendelson, MD FACR, Principal investigator, The Mount Sinai Health SystemJoseph Doyle, PhD, Principal investigator, Massachusetts Institute of TechnologyJesse Shapiro, PhD, Principal investigator, Massachusetts Institute of TechnologyLaura Feeney, MA, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578290
- Sponsor's protocol ID
- JPAL-3872
- Status last verified
- Jan 2017
- First submitted
- 15 Oct 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Centers for Medicare & Medicaid Services, 2013. National Health Expenditures 2013 Highlights. Centers for Medicare & Medicaid Services.
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 24638246Sherman, 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.
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 21385821Medicare Payment Advisory Commission, 2014. Health Care Spending and the Medicare Program. MedPAC.
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 21517834Brenner 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 18046031Pitts, J., 2014. The Protecting Access to Medicare Act of 2014.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Clinical Decision Support (CDS) for Outpatient Radiology Imaging: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02578290
- Acronym / sponsor ID
- JPAL-3872
- Conditions
- CT and MR Image Orders
- Keywords
- decision support systems, clinical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to an error in the implementation of the project, CDS was provided to all providers, rather than to the intended random sample of providers.
- Enrolment
- 2,033 participants (actual)
- Lead sponsor
- Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Oct 2015 (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.
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'.
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 (Centers for Medicare \& Medicaid Services, 2013).
In particular, there is widespread concern in both the medical profession (Callaghan et al., 2014; Sherman, 2012) and the public sector (U.S. Government Accountability Office, 2008) of the cost and health risks of "over-scanning". Estimates suggest that as many as 30% of imaging in the U.S. are unnecessary (Consumer Reports, 2015; Dehn et al., 2000; Georgiou et al., 2011). 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 (Medicare Payment Advisory Commission, 2014); the indirect costs are likely considerably greater, since imaging often triggers additional follow up care (Sherman, 2012; Shreibati and Baker, 2011). It is also estimated that about 2 percent of cancers in the U.S. are due to CT use (Brenner and Hall, 2007).
Reflecting this concern, starting in 2017 Medicare will no longer reimburse for high-cost scans unless ordered using an "acceptable" Clinical Decision Support (CDS) system (Pitts, 2014). Despite this upcoming policy change, we 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 and CT scans, to healthcare providers treating patients in outpatient settings affiliated with Mount Sinai Hospital and Mount Sinai Queens hospital in New York City. 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: one group will receive the CDS, while the remaining providers will serve as the control group.
The CDS will be delivered through the order-entry software, Epic, through ACRSelect 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 computerized 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.'
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Clinical Decision Support (CDS)Clinical Decision Support (CDS) |
| Control | No intervention | –Will not receive Clinical Decision Support (CDS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Opted out of the study prior to October 13, 2015
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 |
|---|---|---|
| Clinical Decision Support (CDS)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. | Other | Treatment |
Primary outcome
number of "non-advised" scans ordered per visiting provider
Time frame: first 365 days after CDS is turned on for the treatment group
"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
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Due to an error in the implementation of the project, CDS was provided to all providers, rather than to the intended random sample of providers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- BackgroundCenters for Medicare & Medicaid Services, 2013. National Health Expenditures 2013 Highlights. Centers for Medicare & Medicaid Services.
- Background: PubMed 24638246Callaghan 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.
- BackgroundSherman, D., 2012. Stemming the tide of overtreatment in U.S. healthcare. Reuters. Feb 16, 2012.
- BackgroundU.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).
- BackgroundConsumer 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).
- BackgroundDehn, 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: PubMed 21385821Georgiou 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.
- BackgroundMedicare Payment Advisory Commission, 2014. Health Care Spending and the Medicare Program. MedPAC.
- Background: PubMed 21517834Shreibati 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.
- Background: PubMed 18046031Brenner 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.
- BackgroundPitts, J., 2014. The Protecting Access to Medicare Act of 2014.
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.
Amy Finkelstein, PhD principal investigator
Massachusetts Institute of Technology
Madhu Mazumdar, Mazumdar principal investigator
The Mount Sinai Health System
Bruce Darrow, MD, PhD principal investigator
The Mount Sinai Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support (CDS) in people with CT and MR Image Orders, run by Abdul Latif Jameel Poverty Action Lab at 2 sites 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 2 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: stopped early, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Due to an error in the implementation of the project, CDS was provided to all providers, rather than to the intended random sample of providers.). Results are not available in the source record.
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 "non-advised" scans ordered per visiting provider (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 NCT02578290, 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 24 Jan 2017.