search
Back to results

Non-Interruptive Alerts for Improving Use of Clinical Decision Rules

Primary Purpose

Pulmonary Embolism, Deep Vein Thrombosis, Minor Head Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Rule Alerts
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring clinical decision support, clinical decision rules

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total clinical decision rule usage
Composite measure of total number of clinical decision rules used through the MDCalc Connect app.

Secondary Outcome Measures

Individual clinical decision rule usage
Number of uses of individual clinical decision rules measured through the MDCalc Connect app.
Computed tomography pulmonary angiography studies
The total number of computed tomography pulmonary angiography studies ordered
Computed tomography head studies
The total number of computed tomography head without contrast studies ordered
Computed tomography c-spine studies
The total number of computed tomography c-spine without contrast studies ordered
Lower extremity ultrasound
The total number of lower extremity ultrasound studies ordered
d-dimer tests
Total number of d-dimer blood tests ordered
Delta troponin tests
Total number of times two or more troponin tests were ordered
Emergency department bounceback rate.
30-day emergency department return visit (or "bounceback") rate
Admission rate
Hospital admission rate

Full Information

First Posted
January 4, 2021
Last Updated
January 9, 2022
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT04702308
Brief Title
Non-Interruptive Alerts for Improving Use of Clinical Decision Rules
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis, Minor Head Injury, Chest Pain, Neck Trauma
Keywords
clinical decision support, clinical decision rules

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Rule Alerts
Intervention Description
The
Primary Outcome Measure Information:
Title
Total clinical decision rule usage
Description
Composite measure of total number of clinical decision rules used through the MDCalc Connect app.
Time Frame
During the intervention
Secondary Outcome Measure Information:
Title
Individual clinical decision rule usage
Description
Number of uses of individual clinical decision rules measured through the MDCalc Connect app.
Time Frame
During the intervention
Title
Computed tomography pulmonary angiography studies
Description
The total number of computed tomography pulmonary angiography studies ordered
Time Frame
During the intervention
Title
Computed tomography head studies
Description
The total number of computed tomography head without contrast studies ordered
Time Frame
During the intervention
Title
Computed tomography c-spine studies
Description
The total number of computed tomography c-spine without contrast studies ordered
Time Frame
During the intervention
Title
Lower extremity ultrasound
Description
The total number of lower extremity ultrasound studies ordered
Time Frame
During the intervention
Title
d-dimer tests
Description
Total number of d-dimer blood tests ordered
Time Frame
During the intervention
Title
Delta troponin tests
Description
Total number of times two or more troponin tests were ordered
Time Frame
During the intervention
Title
Emergency department bounceback rate.
Description
30-day emergency department return visit (or "bounceback") rate
Time Frame
Up to 30 days after the intervention
Title
Admission rate
Description
Hospital admission rate
Time Frame
During the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Non-Interruptive Alerts for Improving Use of Clinical Decision Rules

We'll reach out to this number within 24 hrs