Medical Imaging Decision And Support (MIDAS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Decision Support Systems
• Intervention / Treatment: Other: Active

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Wollny, Dr.; Phone Number: 2975 0049 (0) 821 400; Email: claudia.wollny@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Departments in hospitals that were able to integrate the ESR iGuide system in the ordering system

Exclusion Criteria:

• Departments without electronic medical records or without integration of the decision support system into their computerized order entry system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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.	Other: Active; In the active intervention condition, decision support is provided during the referral procedure of medical imaging exams.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute number of imaging exams	Overall absolute number of imaging exams ordered, total and by exam type.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Collaborators: Erasmus Medical Center; University Hospital Schleswig-Holstein; Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Radiology; Diagnostic Imaging; Referral; Healthcare Costs; Overdiagnosis; Guidelines as Topic; Clinical Trial Protocol
• Other Study ID Numbers: SFV-89-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No