Pulmonary EmbolismNCT04702308
Non-Interruptive Alerts for Improving Use of Clinical Decision Rules
A study testing Clinical Decision Rule Alerts in people with Pulmonary Embolism and Deep Vein Thrombosis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis, Minor Head Injury
- What is being tested?
- Clinical Decision Rule Alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 4 Nov 2022
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Clinical Decision Rule Alerts
- Keywords
- clinical decision support, clinical decision rules
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Craniocerebral Trauma, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Rule AlertsOther
The
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Clinical Decision Rule Alerts |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clinical decision rule usage
Composite measure of total number of clinical decision rules used through the MDCalc Connect app.
Measured: During the intervention
Secondary outcomes (9)
Individual clinical decision rule usage
Number of uses of individual clinical decision rules measured through the MDCalc Connect app.
Measured: During the intervention
Computed tomography pulmonary angiography studies
The total number of computed tomography pulmonary angiography studies ordered
Measured: During the intervention
Computed tomography head studies
The total number of computed tomography head without contrast studies ordered
Measured: During the intervention
Computed tomography c-spine studies
The total number of computed tomography c-spine without contrast studies ordered
Measured: During the intervention
Lower extremity ultrasound
The total number of lower extremity ultrasound studies ordered
Measured: During the intervention
d-dimer tests
Total number of d-dimer blood tests ordered
Measured: During the intervention
Delta troponin tests
Total number of times two or more troponin tests were ordered
Measured: During the intervention
Emergency department bounceback rate.
30-day emergency department return visit (or "bounceback") rate
Measured: Up to 30 days after the intervention
Admission rate
Hospital admission rate
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start18 Feb 2021
- Primary completion18 Nov 2021
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keaton Morgan, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702308
- Sponsor's protocol ID
- 00137874
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04702308
- Acronym / sponsor ID
- 00137874
- Keywords
- clinical decision support, clinical decision rules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 8 Jan 2021 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Clinical Decision Rule AlertsThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Clinical Decision Rule AlertsThe | Other | Intervention Group |
Primary outcome
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.
9 secondary outcomes
Individual clinical decision rule usage
Time frame: During the intervention
Computed tomography pulmonary angiography studies
Time frame: During the intervention
Computed tomography head studies
Time frame: During the intervention
Computed tomography c-spine studies
Time frame: During the intervention
Lower extremity ultrasound
Time frame: During the intervention
d-dimer tests
Time frame: During the intervention
Delta troponin tests
Time frame: During the intervention
Emergency department bounceback rate.
Time frame: Up to 30 days after the intervention
Admission rate
Time frame: During the intervention
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 18 Nov 2023.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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 Clinical Decision Rule Alerts in people with Pulmonary Embolism and Deep Vein Thrombosis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Nov 2023. 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 United States. 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?
Total clinical decision rule usage (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.