Electronic Support for Pulmonary Embolism Emergency Disposition

Pulmonary Embolism Clinical Trial

— eSPEED  

Official title:

Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601676
• Other study ID #: CN-13-1738-H
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: May 30, 2016

Study information

• Verified date: July 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.

Description:

Many low-risk emergency department patients with acute pulmonary embolism are routinely hospitalized despite being eligible for outpatient care. One impediment to home discharge is the difficulty of identifying which patients can safely forego hospitalization. This pragmatic clinical trial intends to evaluate the effect on emergency department disposition of a multicomponent intervention, including electronic clinical decision support system access, physician education, and physician-specific audit and feedback. The hypothesis for this study is that intervention sites, when compared with concurrent control sites, will see an increase in home discharges without an increase in 5-day pulmonary embolism-related return visits or 30-day all-cause mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1703
• Est. completion date: May 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department

Exclusion Criteria:

• Comfort-care only

• Left the ED against medical advice

• Current PE radiologically diagnosed >12 hrs prior to arrival

• Recent DVT or PE diagnosed within 30 days

• Pregnant

Related Conditions & MeSH terms

• Embolism
• Emergencies
• Pulmonary Embolism

Intervention

Other:
• Integration of electronic clinical decision support
Integration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism.

Locations

Country	Name	City	State
United States	Kaiser Permanente Fremont Emergency Department	Fremont	California
United States	Kaiser Permanente Oakland Emergency Department	Oakland	California
United States	Kaiser Permanente Redwood City Emergency Department	Redwood City	California
United States	Kaiser Permanente Richmond Emergency Department	Richmond	California
United States	Kaiser Permanente Roseville Emergency Department	Roseville	California
United States	Kaiser Permanente Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente South Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente San Francisco Emergency Department	San Francisco	California
United States	Kaiser Permanente San Jose Emergency Department	San Jose	California
United States	Kaiser Permanente San Leandro Emergency Department	San Leandro	California
United States	Kaiser Permanente San Rafael Emergency Department	San Rafael	California
United States	Kaiser Permanente Santa Clara Emergency Department	Santa Clara	California
United States	Kaiser Permanente Santa Rosa Emergency Department	Santa Rosa	California
United States	Kaiser Permanente South San Francisco Emergency Department	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of home discharge from the emergency department following treatment for pulmonary embolism		8 months post-implementation compared to 8 months pre-implementation
Secondary	Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality		30 days
Secondary	Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions		5 days