Medical Imaging Decision And Support

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2023

Interventions

  • Other: Active
    • In the active intervention condition, decision support is provided during the referral procedure of medical imaging exams.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Absolute number of imaging exams
    • Time Frame: 1 year
    • Overall absolute number of imaging exams ordered, total and by exam type.
  • Medical radiation from diagnostic imaging
    • Time Frame: 1 year
    • For all types of exams performed the average radiation dose will be collected and multiplied by the number of those types of exams performed.
  • Medical costs for diagnostic imaging
    • Time Frame: 1 year
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Augsburg
  • Collaborator
    • Erasmus Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Claudia Wollny, Dr., 0049 (0) 821 400, claudia.wollny@uk-augsburg.de

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