Electronic Support for Pulmonary Embolism Emergency Disposition (eSPEED)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Other: Integration of electronic clinical decision support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1703
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Kaiser Permanente Fremont Emergency Department
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Emergency Department
    • Redwood City, California, United States, 94063
      • Kaiser Permanente Redwood City Emergency Department
    • Richmond, California, United States, 94801
      • Kaiser Permanente Richmond Emergency Department
    • Roseville, California, United States, 95661
      • Kaiser Permanente Roseville Emergency Department
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento Emergency Department
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento Emergency Department
    • San Francisco, California, United States, 94115
      • Kaiser Permanente San Francisco Emergency Department
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose Emergency Department
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro Emergency Department
    • San Rafael, California, United States, 94903
      • Kaiser Permanente San Rafael Emergency Department
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara Emergency Department
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente Santa Rosa Emergency Department
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente South San Francisco Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of home discharge from the emergency department following treatment for pulmonary embolism	8 months post-implementation compared to 8 months pre-implementation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality	30 days
Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions	5 days

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: David R Vinson, MD, Kaiser Permanente

Publications and helpful links

General Publications

• Vinson DR, Mark DG, Chettipally UK, Huang J, Rauchwerger AS, Reed ME, Lin JS, Kene MV, Wang DH, Sax DR, Pleshakov TS, McLachlan ID, Yamin CK, Elms AR, Iskin HR, Vemula R, Yealy DM, Ballard DW; eSPEED Investigators of the KP CREST Network. Increasing Safe Outpatient Management of Emergency Department Patients With Pulmonary Embolism: A Controlled Pragmatic Trial. Ann Intern Med. 2018 Dec 18;169(12):855-865. doi: 10.7326/M18-1206. Epub 2018 Nov 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Pulmonary Embolism
• Other Study ID Numbers: CN-13-1738-H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No