Clinical Decision Support SystemsMIDASNCT05490290
Medical Imaging Decision And Support
A study testing Active in people with Clinical Decision Support Systems, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Rationale: Diagnostic medical imaging is essential in health care and guides patient management decisions. Rapid advances in imaging technology have enabled diagnosis at an early disease stage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Decision Support Systems
- What is being tested?
- Active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2022to 30 May 2024
- 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
- Departments in hospitals that were able to integrate the ESR iGuide system in the ordering system
Who cannot join
- Departments without electronic medical records or without integration of the decision support system into their computerized order entry system
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Diagnostic medical imaging is essential in health care and guides patient management decisions. Rapid advances in imaging technology have enabled diagnosis at an early disease stage. Nevertheless, striving for early diagnosis leads to substantial overuse of diagnostic tests (too many tests are performed) and overdiagnosis (diagnosed abnormalities that are unlikely to affect a patient's health or well-being), with dire consequences to patient outcomes and health care costs. Computerized decision support systems (CDSS), such as the European Society of Radiology (ESR) iGuide, have been developed to guide referring physicians at the point of care. Objective: The overall objective of this project is to promote the appropriate, meaningful, value-based and personalized use of medical imaging. The specific objectives of this study are to evaluate the trends over time with implementation of a CDSS to guide imaging referrals (ESR iGuide) in key outcomes related to the appropriate use of diagnostic imaging tests, and to compare these trends between departments randomized between implementation of the active intervention (with decision support) and the control condition (no decision support). Study design: The study will be performed as a multi-center cluster randomized trial with departments acting as clusters combined with a before-after-revert design. Four hospitals with each 8 participating departments for a total of 32 clusters will be included in the study. All departments will start with the control condition. Subsequently, stratified per specialty (surgical vs non-surgical), half of the departments - chosen at random - will switch to the active intervention while the other half in the control condition. Study population: The study population consists of patients of eligible participating departments for whom a diagnostic imaging procedure is considered, and for whom a diagnostic imaging request is entered in a computerized order entry in such a form that it is registered by the CDSS.
Intervention: The control condition will consist of computerized order entry with structured data entry of the clinical indication and tracking of the imaging exams requested. The CDSS is implemented but without decision support and physicians are blinded to these referral guidelines. Without their knowledge their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate. They receive no feedback to their requests. In the active intervention the CDSS is implemented with decision support. Physicians are made aware of the referral guidelines and appropriate exams are suggested. Their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate and feedback is provided. Physicians are able to change their request in response to the feedback. In the revert condition decision support is removed to study the sustainable educational effect of temporary use of the system. Main study parameters/endpoints: The primary outcome is the proportion of inappropriate diagnostic imaging exams requested per cluster (department). Inappropriateness is determined by the decision support system and is based on the ESR imaging referral guidelines. Secondary outcomes are the overall absolute number of imaging exams ordered (total and by exam type), estimated medical radiation from diagnostic imaging in investigated groups, and estimated medical costs for diagnostic imaging from the healthcare system perspective in investigated groups.
Read more
Amendment November 2023:
At Johannes Gutenberg University Mainz, the CDSS could not be integrated into the hospital's internal computerized order entry system as required for the study. Therefore, departments from this hospital were not eligible for inclusion. Therefore, and 24 instead of 32 departments were from three locations (Augsburg, Kiel, Lübeck) were randomized accordingly. In a qualitative description of the process of integrating the CDSS in the local hospitals, Mainz will still be included.
- Conditions
- Clinical Decision Support Systems
- Being tested
- Active
- Keywords
- Diagnostic Imaging, Referral, Healthcare Costs, Guidelines as Topic, Clinical Trial Protocol, Overdiagnosis, Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveOther
In the active intervention condition, decision support is provided during the referral procedure of medical imaging exams.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | In the active intervention the CDSS is implemented with decision support. Physicians are made aware of the referral guidelines and appropriate exams are suggested. Their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate and feedback is provided. Physicians are able to change their request in response to the feedback. Receives: Other: Active |
| Control | No intervention | The control condition will consist of computerized order entry with structured data entry of the clinical indication and tracking of the imaging exams requested. The CDSS is implemented but without decision support and physicians are blinded to these referral guidelines. Without their knowledge their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate. They receive no feedback to their requests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of diagnostic imaging exams
The primary outcome is the proportion of inappropriate diagnostic imaging exams in total exams requested per cluster (department) measured by ESR iGuide report tool.
Measured: 1 year
Secondary outcomes (3)
Absolute number of imaging exams
Overall absolute number of imaging exams ordered, total and by exam type.
Measured: 1 year
Medical radiation from diagnostic imaging
For all types of exams performed the average radiation dose will be collected and multiplied by the number of those types of exams performed.
Measured: 1 year
Medical costs for diagnostic imaging
For all types of exams performed the average costs (German costs, healthcare perspective) will be determined and multiplied by the number of those types of exams performed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Dec 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clinical Decision Support SystemsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be performed as a multi-center cluster randomized trial with departments acting as clusters combined with a before-after-revert design. Four hospitals with each 8 participating departments for a total of 32 clusters will be included in the study. All departments will start with the control condition. Subsequently, stratified per specialty (surgical vs. non-surgical), half of the departments - chosen at random - will switch to the active intervention while the other remain in the control condition. Amendments November 2023: I)see Study Description II) We made an amendment to the applied sample size calculation. The original sample size for MERC review was calculated using clusterPower version 0.6.111 function crtpwr.2prop. The amended sample size calculation that in the online publication of the protocol applies a newer, more appropriate version of clusterPower version 0.7.0 using the function cpa.did.binary.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490290
- Sponsor's protocol ID
- SFV-89-19
- Acronym
- MIDAS
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dijk SW, Mommersteeg M, Steltenpool S, Wollny C, van der Voorn M, van Os Z, Kroencke T. Inappropriate imaging requests in abdominal imaging: observations from the MIDAS study, a multicenter randomized controlled trial in Germany. Abdom Radiol (NY). 2026 Jul;51(7):3690-3696. doi: 10.1007/s00261-025-05300-4. Epub 2025 Dec 19.
PubMed 41417083Kroencke T, Dijk SW, Halfmann MC, Wollny C, Barkhausen J, Janssen O, Rizopoulos D, Myriam Hunink MG. Challenges and insights from implementing clinical decision support systems for radiologic imaging: experience from the MIDAS trial. Insights Imaging. 2025 Jul 5;16(1):152. doi: 10.1186/s13244-025-02027-0.
PubMed 40616704Dijk SW, Wollny C, Barkhausen J, Jansen O, Mildenberger P, Halfmann MC, Stroeder J, Rizopoulos D, Hunink MGM, Kroencke T. Evaluation of a Clinical Decision Support System for Imaging Requests: A Cluster Randomized Clinical Trial. JAMA. 2025 Apr 8;333(14):1212-1221. doi: 10.1001/jama.2024.27853.
PubMed 39928308Dijk SW, Kroencke T, Wollny C, Barkhausen J, Jansen O, Halfmann MC, Rizopoulos D, Hunink MGM. Medical Imaging Decision And Support (MIDAS): Study protocol for a multi-centre cluster randomized trial evaluating the ESR iGuide. Contemp Clin Trials. 2023 Dec;135:107384. doi: 10.1016/j.cct.2023.107384. Epub 2023 Nov 8.
PubMed 37949165
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging Decision And Support
- ClinicalTrials.gov ID
- NCT05490290
- Acronym / sponsor ID
- MIDAS / SFV-89-19
- Conditions
- Clinical Decision Support Systems
- Keywords
- Diagnostic Imaging, Referral, Healthcare Costs, Guidelines as Topic, Clinical Trial Protocol, Overdiagnosis, Radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 5 Aug 2022 (actual)
- 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.
Rationale: Diagnostic medical imaging is essential in health care and guides patient management decisions. Rapid advances in imaging technology have enabled diagnosis at an early disease stage. Nevertheless, striving for early diagnosis leads to substantial overuse of diagnostic tests (too many tests are performed) and overdiagnosis (diagnosed abnormalities that are unlikely to affect a patient's health or well-being), with dire consequences to patient outcomes and health care costs. Computerized decision support systems (CDSS), such as the European Society of Radiology (ESR) iGuide, have been developed to guide referring physicians at the point of care. Objective: The overall objective of this project is to promote the appropriate, meaningful, value-based and personalized use of medical imaging. The specific objectives of this study are to evaluate the trends over time with implementation of a CDSS to guide imaging referrals (ESR iGuide) in key outcomes related to the appropriate use of diagnostic imaging tests, and to compare these trends between departments randomized between implementation of the active intervention (with decision support) and the control condition (no decision support). Study design: The study will be performed as a multi-center cluster randomized trial with departments acting as clusters combined with a before-after-revert design. Four hospitals with each 8 participating departments for a total of 32 clusters will be included in the study. All departments will start with the control condition. Subsequently, stratified per specialty (surgical vs non-surgical), half of the departments - chosen at random - will switch to the active intervention while the other half in the control condition. Study population: The study population consists of patients of eligible participating departments for whom a diagnostic imaging procedure is considered, and for whom a diagnostic imaging request is entered in a computerized order entry in such a form that it is registered by the CDSS.
Intervention: The control condition will consist of computerized order entry with structured data entry of the clinical indication and tracking of the imaging exams requested. The CDSS is implemented but without decision support and physicians are blinded to these referral guidelines. Without their knowledge their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate. They receive no feedback to their requests. In the active intervention the CDSS is implemented with decision support. Physicians are made aware of the referral guidelines and appropriate exams are suggested. Their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate and feedback is provided. Physicians are able to change their request in response to the feedback. In the revert condition decision support is removed to study the sustainable educational effect of temporary use of the system. Main study parameters/endpoints: The primary outcome is the proportion of inappropriate diagnostic imaging exams requested per cluster (department). Inappropriateness is determined by the decision support system and is based on the ESR imaging referral guidelines. Secondary outcomes are the overall absolute number of imaging exams ordered (total and by exam type), estimated medical radiation from diagnostic imaging in investigated groups, and estimated medical costs for diagnostic imaging from the healthcare system perspective in investigated groups.
Amendment November 2023:
At Johannes Gutenberg University Mainz, the CDSS could not be integrated into the hospital's internal computerized order entry system as required for the study. Therefore, departments from this hospital were not eligible for inclusion. Therefore, and 24 instead of 32 departments were from three locations (Augsburg, Kiel, Lübeck) were randomized accordingly. In a qualitative description of the process of integrating the CDSS in the local hospitals, Mainz will still be included.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be performed as a multi-center cluster randomized trial with departments acting as clusters combined with a before-after-revert design. Four hospitals with each 8 participating departments for a total of 32 clusters will be included in the study. All departments will start with the control condition. Subsequently, stratified per specialty (surgical vs. non-surgical), half of the departments - chosen at random - will switch to the active intervention while the other remain in the control condition. Amendments November 2023: I)see Study Description II) We made an amendment to the applied sample size calculation. The original sample size for MERC review was calculated using clusterPower version 0.6.111 function crtpwr.2prop. The amended sample size calculation that in the online publication of the protocol applies a newer, more appropriate version of clusterPower version 0.7.0 using the function cpa.did.binary.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Other: ActiveIn the active intervention the CDSS is implemented with decision support. Physicians are made aware of the referral guidelines and appropriate exams are suggested. Their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate and feedback is provided. Physicians are able to change their request in response to the feedback. |
| Control | No intervention | –The control condition will consist of computerized order entry with structured data entry of the clinical indication and tracking of the imaging exams requested. The CDSS is implemented but without decision support and physicians are blinded to these referral guidelines. Without their knowledge their imaging requests are categorized as appropriate, under certain conditions appropriate, or inappropriate. They receive no feedback to their requests. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Departments in hospitals that were able to integrate the ESR iGuide system in the ordering system
Key exclusion criteria (1 listed)
- Departments without electronic medical records or without integration of the decision support system into their computerized order entry system
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 |
|---|---|---|
| ActiveIn the active intervention condition, decision support is provided during the referral procedure of medical imaging exams. | Other | Active |
Primary outcome
Appropriateness of diagnostic imaging exams
Time frame: 1 year
The primary outcome is the proportion of inappropriate diagnostic imaging exams in total exams requested per cluster (department) measured by ESR iGuide report tool.
3 secondary outcomes
Absolute number of imaging exams
Time frame: 1 year
Medical radiation from diagnostic imaging
Time frame: 1 year
Medical costs for diagnostic imaging
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 41417083Dijk SW, Mommersteeg M, Steltenpool S, Wollny C, van der Voorn M, van Os Z, Kroencke T. Inappropriate imaging requests in abdominal imaging: observations from the MIDAS study, a multicenter randomized controlled trial in Germany. Abdom Radiol (NY). 2026 Jul;51(7):3690-3696. doi: 10.1007/s00261-025-05300-4. Epub 2025 Dec 19.
- Derived from this study: PubMed 40616704Kroencke T, Dijk SW, Halfmann MC, Wollny C, Barkhausen J, Janssen O, Rizopoulos D, Myriam Hunink MG. Challenges and insights from implementing clinical decision support systems for radiologic imaging: experience from the MIDAS trial. Insights Imaging. 2025 Jul 5;16(1):152. doi: 10.1186/s13244-025-02027-0.
- Derived from this study: PubMed 39928308Dijk SW, Wollny C, Barkhausen J, Jansen O, Mildenberger P, Halfmann MC, Stroeder J, Rizopoulos D, Hunink MGM, Kroencke T. Evaluation of a Clinical Decision Support System for Imaging Requests: A Cluster Randomized Clinical Trial. JAMA. 2025 Apr 8;333(14):1212-1221. doi: 10.1001/jama.2024.27853.
- Derived from this study: PubMed 37949165Dijk SW, Kroencke T, Wollny C, Barkhausen J, Jansen O, Halfmann MC, Rizopoulos D, Hunink MGM. Medical Imaging Decision And Support (MIDAS): Study protocol for a multi-centre cluster randomized trial evaluating the ESR iGuide. Contemp Clin Trials. 2023 Dec;135:107384. doi: 10.1016/j.cct.2023.107384. Epub 2023 Nov 8.
- Study Protocol Published in the journal Contemporary Clinical Trials - "Medical Imaging Decision And Support (MIDAS): Study protocol for a multi-centre cluster randomized trial evaluating the ESR iGuide"Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Clinical Decision Support Systems, run by University Hospital Augsburg at 1 site in Germany.
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 1 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 30 Jan 2025. 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 Germany. 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?
Appropriateness of diagnostic imaging exams (time frame: 1 year). 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 NCT05490290, which also lists 4 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 30 Jan 2025.