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Non-Interruptive Alerts for Improving Use of Clinical Decision Rules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702308
Recruitment Status : Enrolling by invitation
First Posted : January 8, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Keaton Morgan, University of Utah

Brief Summary:
This study is an extension of a planned quality improvement project that aims to promote standard of care by increasing the use of evidence-based clinical decision rules amongst emergency medicine providers in the University of Utah Emergency Department. Patient-specific information from the EHR will be used to recommend the use of relevant clinical decision rules to emergency medicine providers at the point-of-care. These recommendations will be in the form of non-interruptive alerts with one-click access to the suggested decision rules through the MDCalc Connect EHR add-on application. Specific aims of the study are to determine if 1) patient-specific non-interruptive alerts increase the use of clinical decision rules amongst emergency medicine providers and 2) an increase in the use of clinical decision rules affects provider ordering habits.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Deep Vein Thrombosis Minor Head Injury Chest Pain Neck Trauma Other: Clinical Decision Rule Alerts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Non-Interruptive Alerts for Improving the Use of Clinical Decision Rules in the Emergency Department: A Cluster Randomized Controlled Trial
Actual Study Start Date : February 18, 2021
Actual Primary Completion Date : November 18, 2021
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Intervention Group
The intervention will contain two components: 1) a non-interruptive best practice advisory (BPA) in the Epic Storyboard and 2) a default suggested calculator tab in the MDCalc Connect app. Six clinical decision rules will be included: Canadian CT Head Rule, Canadian C-spine Rule, HEART Score, PERC Rule, Wells' PE Criteria and Wells' DVT Criteria. Predefined criteria based on chief complaint, patient age and vital signs will be used to determine when a decision rule may be relevant in a patient encounter. When a patient meets all of the predefined criteria, the intervention will be triggered.
Other: Clinical Decision Rule Alerts
The

No Intervention: Control Group
The control group will be usual care. Specifically, providers in the control group will not receive the clinical decision rule alert or the default suggested calculator tab in the MDCalc Connect app. The control group providers will have access to the MDCalc Connect app in its standard form and functionality.



Primary Outcome Measures :
  1. Total clinical decision rule usage [ Time Frame: During the intervention ]
    Composite measure of total number of clinical decision rules used through the MDCalc Connect app.


Secondary Outcome Measures :
  1. Individual clinical decision rule usage [ Time Frame: During the intervention ]
    Number of uses of individual clinical decision rules measured through the MDCalc Connect app.

  2. Computed tomography pulmonary angiography studies [ Time Frame: During the intervention ]
    The total number of computed tomography pulmonary angiography studies ordered

  3. Computed tomography head studies [ Time Frame: During the intervention ]
    The total number of computed tomography head without contrast studies ordered

  4. Computed tomography c-spine studies [ Time Frame: During the intervention ]
    The total number of computed tomography c-spine without contrast studies ordered

  5. Lower extremity ultrasound [ Time Frame: During the intervention ]
    The total number of lower extremity ultrasound studies ordered

  6. d-dimer tests [ Time Frame: During the intervention ]
    Total number of d-dimer blood tests ordered

  7. Delta troponin tests [ Time Frame: During the intervention ]
    Total number of times two or more troponin tests were ordered

  8. Emergency department bounceback rate. [ Time Frame: Up to 30 days after the intervention ]
    30-day emergency department return visit (or "bounceback") rate

  9. Admission rate [ Time Frame: During the intervention ]
    Hospital admission rate



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • 16 years of age or older
  • Qualifying chief complaint*

Patient Exclusion Criteria:

  • None

    • A full list of the qualifying chief complaints is provided in Appendix A of the full research protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702308


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
  Study Documents (Full-Text)

Documents provided by Keaton Morgan, University of Utah:
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Responsible Party: Keaton Morgan, Postdoctoral Fellow, University of Utah
ClinicalTrials.gov Identifier: NCT04702308    
Other Study ID Numbers: 00137874
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keaton Morgan, University of Utah:
clinical decision support
clinical decision rules
Additional relevant MeSH terms:
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Pulmonary Embolism
Craniocerebral Trauma
Thrombosis
Embolism
Venous Thrombosis
Chest Pain
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries